[Senate Hearing 107-368]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-368
 
      ALZHEIMER'S RESEARCH AND CARE: HELPING PATIENTS AND FAMILIES
=======================================================================


                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON AGING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             SECOND SESSION

                                   ON

  EXAMINING THE ISSUE OF ALZHEIMER'S AND THE ROLE THAT THE COMMITTEE 
            PLAYS IN THE REAUTHORIZATION OF THE LEGISLATION

                               __________

                     APRIL 2, 2002 (BALTIMORE, MD)

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions











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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

               EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut     JUDD GREGG, New Hampshire
TOM HARKIN, Iowa                     BILL FRIST, Tennessee
BARBARA A. MIKULSKI, Maryland        MICHAEL B. ENZI, Wyoming
JAMES M. JEFFORDS (I), Vermont       TIM HUTCHINSON, Arkansas
JEFF BINGAMAN, New Mexico            JOHN W. WARNER, Virginia
PAUL D. WELLSTONE, Minnesota         CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             PAT ROBERTS, Kansas
JACK REED, Rhode Island              SUSAN M. COLLINS, Maine
JOHN EDWARDS, North Carolina         JEFF SESSIONS, Alabama
HILLARY RODHAM CLINTON, New York     MIKE DeWINE, Ohio
           J. Michael Myers, Staff Director and Chief Counsel
             Townsend Lange McNitt, Minority Staff Director
                                 ------                                

                         Subcommittee on Aging

                BARBARA A. MIKULSKI, Maryland, Chairman
CHRISTOPHER J. DODD, Connecticut     TIM HUTCHINSON, Arkansas
PATTY MURRAY, Washington             JUDD GREGG, New Hampshire
JOHN EDWARDS, North Carolina         JOHN W. WARNER, Virginia
HILLARY RODHAM CLINTON, New York     PAT ROBERTS, Kansas
                    Rhonda Richards, Staff Director
             C. Kate Lambrew Hull, Minority Staff Director













                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                         Tuesday, April 2, 2002

                                                                   Page
Mikulski, Hon. Barbara A., a U.S. Senator from the State of 
  Maryland.......................................................     1
    Prepared statement...........................................     3
Hutchinson, Hon. Tim, a U.S. Senator from the State of Arkansas..     5
Savage, Peter V., caregiver, Baltimore, MD.......................     6
    Prepared statement...........................................    32
Naugle, Cass, Executive Director, Central Maryland Chapter, 
  Alzheimer's Association........................................     8
    Prepared statement...........................................    33
Salerno, Judith A., M.D., Deputy Director, National Institute on 
  Aging, National Institutes of Health...........................    18
    Prepared statement...........................................    36
Lyketsos, Constantine G., M.D., professor, Johns Hopkins 
  University School of Medicine, Baltimore, MD, on behalf of the 
  Alzheimer's Association........................................    20
    Prepared statement...........................................    39

                          Additional Material

Vaeth, Sue, Senior Care Manager, Maryland Department of Aging, 
  Baltimore, MD..................................................    34
Nyankale, Henrique S., Caregiver, Gaithersburg, MD...............    42
  
















      ALZHEIMER'S RESEARCH AND CARE: HELPING PATIENTS AND FAMILIES

                              ----------                              


                         TUESDAY, APRIL 2, 2002

                               U.S. Senate,
                             Subcommittee on Aging,
       Committee on Health, Education, Labor, and Pensions,
                                                     Washington, DC
    The subcommittee met, pursuant to notice, at 10:10 a.m., at 
the Gerontology Research Center, Johns Hopkins Bayview Medical 
Center, Baltimore, Maryland, Hon. Barbara A. Mikulski [chairman 
of the subcommittee] presiding.
    Present: Senator Mikulski.

                 Opening Statement of Senator Mikulski

    Senator Mikulski. Good morning, everybody.
    The United States Senate Committee on Health, Education, 
Labor, and Pensions will come to order.
    This is a hearing of the Subcommittee on Aging, of which I 
am the chairperson, and it is a field hearing on the issue of 
Alzheimer's and the role that the committee plays in the 
reauthorization of Alzheimer's legislation.
    I am glad to be once again back at Bayview, where I visited 
in 1999. At that time, I said that I was very deeply troubled 
that the National Institute on Aging's budget was quite 
spartan, that it was close to $600 million, when Alzheimer's is 
one of the most devastating chronic conditions to affect 
primarily older Americans.
    At that time, the National Institute on Aging's budget was 
$600 million. That was for the whole National Institute on 
Aging, including diabetes, cardiovascular disease, Parkinson's, 
and Alzheimer's. Alzheimer's research got $323 million, and I 
knew that we needed more money to come up with more ideas on 
how to deal with both the issues of aging, health, as well as 
Alzheimer's.
    At that time, I said to my constituents here that I 
promised to fight for more funding for the National Institute 
on Aging. I was not going to fight just for incremental 
increases; I said that I was going to work my earrings off to 
double the funding for the National Institute on Aging. Well, I 
have my earrings here; I worked them off. And I am happy to 
announce today that when we pass the appropriations bills this 
year, we will have doubled the funding for the National 
Institute on Aging.
    I have a little saying, which is that ``each and every one 
of us can make a difference,'' and I know that all of you in 
this room are already making a difference, from the researchers 
who are working

[[Page 2]]

so hard on cures and cognitive stretch-outs to the advocates 
who speak up for the families of those with Alzheimer's to the 
caregivers as well as the public policy administrators. Each of 
you has made a difference, but we have all worked together on 
this change, and I believe that when we do work together, we do 
make change.
    This year when we implement the President's request, the 
National Institute on Aging budget will be $1 billion--$1 
billion. Alzheimer's research for this year will go from a 
little over $300 million in 1998 to $600 million. This is 
really a great victory, and everybody in this room has worked 
so hard, as well as your counterparts nationwide.
    Now, this is not about money; it is really about mission. 
Doubling the budget for the National Institute on Aging is 
paying off. I took a tour this morning to see what the research 
looks like. Scientists have found evidence that a drug that is 
now used to lower cholesterol might prevent Alzheimer's. 
Researchers are testing a vaccine on mice that might also help 
deal with these issues.
    There are currently seven clinical trials looking at 
whether estrogen, Vitamin E, and even aspirin might help to 
prevent Alzheimer's or prevent the onset of Alzheimer's, in 
other words, delay the onset.
    Cutting-edge research demands cutting-edge facilities. When 
I took this tour 3 years ago, the building in which world-class 
research was going on was really a third-class building. World-
class research needs world-class facilities.
    So Senator Sarbanes, Congressman Ben Cardin and I teamed up 
with Hopkins to outwit the General Services Administration on 
how we could get you a new building faster, cheaper, and 
better-equipped on the drawing board. We won that victory, and 
next year, we are going to have a groundbreaking for a new 
facility that will mean better labs, better collaboration, and 
the ability to do better research.
    So we now have the money, we now have the building, because 
we know that more needs to be done. Alzheimer's disease is a 
devastating illness. One in 10 people over 65 and nearly half 
of those over 85 will experience it.
    The issue of family caregiving, on which I will be holding 
a hearing later on in the spring, means that caregiving 
families through their own family sweat equity really put into 
the economy. If caregivers were to be paid a wage for what they 
do for their own families, their spouse, their parent or 
whatever, it would come out to about $196 billion of real sweat 
equity from the American people.
    We need to get help to those who practice self-help, and 
not only breakthroughs, but cures and cognitive ability to 
stretch out and help for the caregiver.
    So we will be hearing more about these issues as this 
hearing is going on.
    I have recently introduced a bill to make sure that 
Alzheimer's families have the support they need, both in the 
lab and in the community. With Senator Kennedy and Senator 
Clinton, and also on a bipartisan basis, we have introduced 
legislation to be able to do this, to be able to improve the 
care of patients, and again, we will talk more about that.

[[Page 3]]

    But I want to listen to you now. Yes, I have fought hard 
for the funding for Alzheimer's research and care, because I 
understand what it does to families. My dear father had 
Alzheimer's. I have said that I watched my father die one brain 
cell at a time. My father was a very modest man, a hardworking 
man. He owned a grocery store just a few blocks from this 
building where we sit today. My father would not have wanted a 
big monument built to him, but he would have been very proud 
that the young lady that he sacrificed so much to send to 
school was out there to help other dads like himself. He and my 
mother raised me to be a fighter, to stand up for what is 
right, and I believe that the commandment of ``Honor your 
mother and your father'' is not only a good commandment to live 
by, but it is also a very good commandment to govern by. This 
is why I work so hard on issues affecting aging.
    We used Bayview; we had the geriatric evaluation under Dr. 
John Burton. Dad used the Mason Lord adult daycare that was so 
important to both care for him and give my mother a bit of a 
breather. And then, as a very young social worker, I was also 
out here when Mason Lord and Mazie Rappaport, a social worker, 
were doing pioneering work.
    Wherever pioneering thought was given and where compassion 
was linked with care and research, it was right here at 
Bayview, right here on this campus.
    So we are very pleased to be here and be able to be an 
advocate and make sure that families that have worked hard all 
of their lives will have the opportunity to enjoy that life.
    With that, I will conclude my remarks and turn to our 
witnesses.
    [The prepared statement of Senator Mikulski follows:]

                 Prepared Statement of Senator Mikulski

    I'm happy to be back here at Bayview. The last time I was 
here was in June 1999. The National Institute on Aging's budget 
was spartan, just $597 million. Alzheimer's research got just 
$323 million. I promised to fight for more funding for the 
National Institute on Aging. Not just an incremental increase--
I promised to double the funding.
    I have good news to share with you. I've kept that promise. 
The National Institute on Aging's budget will be more than $1 
billion this year. That's double what it was 5 years ago. 
Alzheimer's research this year will receive more than $600 
million. It's a great victory because of the important work 
done here at Bayview.
    Doubling the budget for the National Institute on Aging is 
paying off. Scientists have found evidence that a cholesterol-
lowering drug may prevent Alzheimer's. Researchers are testing 
a vaccine on mice that may prevent the disease in humans. Seven 
clinical trials are currently underway to find out whether 
estrogen, vitamin E, gingko biloba, and aspirin help to prevent 
Alzheimer's.
    This cutting edge research demands cutting edge facilities. 
That's why I fought, with the help of Senator Sarbanes and 
Congressman Cardin, to make sure NIA research will have a new 
state-of-the art facility here at Bayview. A new facility means 
better labs, better collaboration by working together at 
central location, and a better chance of recruiting the best 
researchers from around the world.

[[Page 4]]

    Even with these victories, there is still a lot more to do. 
Alzheimer's Disease is a devastating illness. Four million 
Americans suffer from Alzheimer's, including one in ten people 
over age 65 and nearly half of those over age 85. Nineteen 
million Americans say they have a family member with the 
disease. The Medicare program alone spent $31.9 billion for the 
care of people with Alzheimer's disease in the year 2000. 
Without a cure, the number of Alzheimer's patients will more 
than triple in the next 50 years. Fourteen million Americans 
will suffer from Alzheimer's by 2050. If science can help delay 
the onset of Alzheimer's by even 5 years, it would improve the 
lives of millions of families and save billions of dollars.
    Now I'm fighting to make sure Alzheimer's families have the 
support they need, both in the lab and in the community. I have 
introduced legislation that helps to meet the day-to-day needs 
of seniors and the long-range needs of our Nation. This bill 
reauthorizes the Alzheimer's Demonstration Program that helps 
patients and families get support services like respite care 
and home health care. It connects public and private resources 
to improve the care for patients and their families. And, it 
focuses on helping the people who are hardest to reach or 
underserved. This important program is set to expire this year. 
I'm fighting instead to expand this program to every State, to 
keep our promises to America's families. I look forward to 
hearing from Cass Naugle today about the Demonstration Program 
in Maryland and others like it around the country.
    My bill also addresses the long term needs of our aging 
Nation by expanding Alzheimer's research at the National 
Institute on Aging. It expands the Alzheimer's Disease 
Prevention Initiative to speed up the discovery of new ways to 
prevent the disease. My bill establishes a research program on 
ways to help caregivers of Alzheimer's patients.
    I fight hard for more funding for Alzheimer's research and 
care because I understand what Alzheimer's does to those who 
have it and their families. My dear father suffered from 
Alzheimer's. We had hoped it was a vitamin deficiency, and all 
he needed was for the family to pitch in and send Mom and Dad 
on a cruise. Instead the diagnosis was Alzheimer's. My family 
and I watched him die one brain cell at a time. My Dad got care 
right here at Mason Lord. He had a geriatric evaluation and 
went to adult daycare. I believe that ``Honor Thy Father and 
Mother'' is not only a good commandment to live by, it's a good 
policy to govern by.
    Thank you all for coming to today's hearing on Alzheimer's 
Disease, especially those of you who took time off from work or 
away from your loved ones to be here. I hope that by coming to 
you we've made this a little easier. We have two panels today 
to discuss where we need to go in terms of research and care: 
Peter Savage, who cares for his wife, Ina, and Cass Naugle, 
Executive Director of Central Maryland Alzheimer's Association, 
will testify on the first panel. Dr. Judy Salerno, Deputy 
Director of NIA, and Dr. Constantine Lyketsos, a researcher at 
Johns Hopkins University, will testify on the second panel.
    Thank you for your great work and commitment to this fight. 
I am looking forward to our discussion.

[[Page 5]]

    Senator Mikulski. Before we begin I have a statement of 
Senator Hutchinson.
    [The prepared statement of Senator Hutchinson follows:]

                Prepared Statement of Senator Hutchinson

    Senator Mikulski, thank you for holding this hearing today. 
As an original co-sponsor of S. 2059, the Alzheimer's Disease 
Research, Prevention and Care Act of 2002, I want to express my 
strong support for your efforts, Madame Chairman, to promote 
Alzheimer's research and awareness. Alzheimer's is a 
degenerative neurological disorder that is the leading cause of 
dementia, which results in impaired thinking, memory, and 
behavior. It currently afflicts nearly 4 million Americans, a 
number which is estimated to increase to approximately 14 
million Americans by 2050 unless science finds a cure or a way 
to prevent the disease.
    The cause of Alzheimer's disease is currently unknown, and 
the medications available only slow the progress of the 
disease. Seventy percent of Alzheimer's patients are cared for 
at home by family or friends. Their home care will cost an 
average of $12,500 per year. Many of these patients need to 
live in assisted living or long-term care facilities, however. 
Nursing care for these patients can often exceed $40,000 per 
year. The total cost of Alzheimer's care in the United States 
today is estimated at almost $100 billion annually. With the 
aging baby boomer generation approaching retirement, millions 
of Americans will continue to be affected by this horrible 
disease. The need for a cure has never been greater.
    To help scientists and medical researchers find a cure, I 
joined Senator Mikulski in supporting S. 2059, the Alzheimer's 
Disease Research, Prevention, and Care Act of 2002. This 
important legislation recognizes that the most effective way to 
curb the number of patients affected by Alzheimer's disease is 
to find a way to prevent it before it starts. The bill 
authorizes the Alzheimer's Disease Prevention Initiative, which 
directs the National Institute on Aging (NIA) to focus its 
efforts on identifying possible preventive interventions and 
undertaking clinical trials to test their effectiveness.
    In addition, S. 2059 will reauthorize the Alzheimer's 
Demonstration Grant Program to develop and replicate innovative 
ways to provide care to Alzheimer's patients that are 
traditionally hard to reach or underserved. It expands the 
program by providing funding to support programs in every 
State. The Alzheimer's Disease Research, Prevention and Care 
Act also authorizes $1.5 billion for the NIA for research and 
development, as well as establishing a program to conduct 
caregiver research.
    Making the investment to treat Alzheimer's disease today 
means healthier lives for everyone tomorrow. We will find a 
treatment for Alzheimer's, but first we must make the 
commitment to invest the resources now to prevent this disease 
from continuing its progression undeterred.
    Senator Mikulski. I believe that the best ideas come from 
the people, so we are going to have two panels today. Our first 
panel includes Mr. Peter Savage, an old friend and someone I 
have known over the years who comes with great first-hand 
experience; and also, Cass Naugle, who is Executive Director of 
the Central

[[Page 6]]

Maryland Chapter of the Alzheimer's Association. Following 
that, we will hear from the researchers on our second panel.
    Mr. Savage, we welcome you here and look forward to your 
testimony. I know that you have first-hand insights that you 
would like to share with us.
    Ms. Naugle, I know that you have overseen the growth of the 
Central Maryland Chapter of the Alzheimer's Association. When 
you took over, they had a budget of $50,000; it is now $1.4 
million. I thought I was doing well doubling the NIA budget; I 
have got to talk to you. You have a lot of secrets to tell me. 
But I know that in addition to being an advocate, you look out 
for your mom, who is also dealing with this issue, and you know 
the pain first-hand.
    Mr. Savage, please go ahead.

     STATEMENT OF PETER V. SAVAGE, CAREGIVER, BALTIMORE, MD

    Mr. Savage. Thank you.
    On behalf of three daughters who are at risk, Senator, I 
would like to thank you very much for your efforts, because I 
have the problem directly, but I also have the fear of the 
problem indirectly, and that funding, it seems to me, is going 
to make a difference. I was asked to talk about the effects of 
Alzheimer's on family and access to research, which I will try 
to do.
    It seems to me that there are really no generalizations, 
because each family's situation is slightly different. The 
progress of the disease manifests itself at different speeds, 
and where the disease goes quickly, it overcomes emotional 
defenses and financial resources and, I would imagine, leaves 
chaos. That has not been my case.
    My wife, being Brazilian, and our family approach being an 
extended family support system, our approach has been--you talk 
about sweat equity--a lot of family and extended family and a 
lot of friends who are involved. Each daughter has been a part 
of research on what has been done. One looked into elder care; 
one looked at eldercare lawyers; another looked into 
Alzheimer's support groups, which is how we got to meet Cass. 
And when full-time support was necessary, they finally placed 
an ad in the newspaper, and after many mistakes, we found that 
not necessarily nurses were appropriate, but people who were 
really resourceful were appropriate. We went through 35 
interviewees and finally found a group of people who could 
serve as a support group for my wife on an around-the-clock 
basis.
    And I would emphasize that perhaps the most important thing 
in the success of that effort was the compatibility of those 
people with my wife. My wife does not tolerate fools gladly, 
and there are a lot of people in this business who will tell 
you, ``I do not do windows, and I do not do this, and I do not 
do that''--and that is not helpful. What you really need is 
somebody who can take on the responsibility of dealing with 
someone who has a flexible agenda and a menu of things that are 
needed.
    Part of the problem in the case of my wife was that she was 
such a super-confident person to begin with. She still speaks 
two or three languages, but she spoke five languages. She ran a 
very tight ship when she ran the household. She brought up 
three very sane

[[Page 7]]

children, and for better or for worse, she is one of those 30 
percent of the people who knows full well what is going on and 
exactly what are the consequences of where we are going. That 
produces tears occasionally.
    There are still some outstanding issues which we have to 
face. We have not dealt with all of them. We still have to deal 
with long-term health care or home care, and there is the 
possibility of institutionalization, and then the question of 
how the resources will go to pay for that; and there is 
increasing dependency.
    I would say that in this struggle, there have been some 
heroes and some villains in the process. I can say that a 
competent eldercare lawyer--he or she--is clearly one of those 
heroes. And I will not name names, but I can just say that 
there are a number of people who are highly recommended. And 
indeed, I came through Cass Naugle and through Alzheimer's 
Association and through the recommendations of support groups 
to find exactly the person or people whom we needed.
    I would say that one hero is Dr. Claudia Kawas, formerly of 
the Johns Hopkins Bayview Neurological Center. Those at 
Shepherd Pratt who determined that my wife had Alzheimer's in 
1995 sent us to her as one of the alternatives, and when she 
was conducting clinical trials, she slotted Ina for the 
appropriate place and was very helpful.
    She also believed in psychological counseling, saying that 
it was not a dead-end disease where you just throw people out 
once they get this disease. So we then worked out with Dr. 
Koliatsos of Shepherd Pratt and their neuropsychiatric program 
so that Ina has care and attention, and that is a really good 
settling influence. It means that you see a psychologist, or 
you see a social worker, and you have rules of discussion so 
that when you have problems in the household, you have somebody 
to go to who is really an arbiter, and that has been no end of 
help.
    I would also say that there are some villains in this 
fight, and one of the villains is the insurance companies who 
deny coverage by reason of pre-existing conditions. That is a 
problem that we have overcome by incorporating; we had to do 
that to get around that problem. But even so, for example, the 
Johns Hopkins neuropsychology service cannot accept our 
insurance because the costs just are not covered, so that 
something is automatically eliminated.
    I would also say that the worst villain is Social Security. 
They play by their own rules. They do not accept the power-of-
attorney. They do not accept a signature stamp. They clearly 
have a policy of lack of helpful cooperation from the start, 
and they deny applications just readily. In my case, there is a 
complicated issue which I am going to have to hire a lawyer to 
solve.
    Remedies--I cannot say that there is any easy one, but get 
a sense of humor; talk through the problems, including the 
patient in the discussions. We are now writing a book of 101 
bad Alzheimer's jokes. It starts with Easter: One of the 
benefits of Alzheimer's is that a patient can hide her own 
Easter eggs.
    Thank you very much.
    [The prepared statement of Mr. Savage may be found in 
additional material.]

[[Page 8]]

    Senator Mikulski. Thank you very much, Mr. Savage. You have 
raised some very important issues, one of which is the whole 
issue of medical care and even how, while we are talking about 
health insurance, the HMO situation, and so on, there is also 
even a question of what Medicare would pay for.
    The Bush administration has made changes which I found out 
by reading the newspaper. After you conclude your testimony and 
before we go to the research panel, I am going to ask Ms. 
Richards on my staff to share with you what we know about what 
the changes are, because I think we have got to be able to get 
this out to the community.
    Thank you very much for your testimony, and I want to 
acknowledge your wife being here and the great dignity with 
which she presents herself.
    Mr. Savage. Thank you.
    Senator Mikulski. Cass Naugle.

STATEMENT OF CASS NAUGLE, EXECUTIVE DIRECTOR, CENTRAL MARYLAND 
                CHAPTER, ALZHEIMER'S ASSOCIATION

    Ms. Naugle. Senator Mikulski, I am pleased to have the 
opportunity to discuss the impact of the Alzheimer's Disease 
Demonstration Grants to States Program. This program was 
created in recognition that 4 million Americans are affected by 
Alzheimer's disease and that most of their care is provided in 
the community by family members.
    The goals of the Alzheimer's Disease Demonstration Grants 
to States Program are to increase the availability of 
supportive services for people with Alzheimer's and their 
caregivers and to assure that these services are effectively 
coordinated.
    In addition to working as executive director of an 
Alzheimer's Association chapter, I have experienced this 
disease first-hand. First, my father's sister, who helped raise 
me, developed Alzheimer's, then, my mother's younger brother. 
My father was then diagnosed, and we cared for him at home for 
3 years until he passed away last June. Now my mom is a victim 
of this disease.
    Using adult day services and in-home caregivers, my 
siblings and I are able to keep her in her home, which is very 
important to her right now. This is the home where she was 
born, where she raised eight children, and where she lived with 
my father for 62 years.
    As difficult as it has been to lose people I love to this 
disease, I know that my family was fortunate. I knew what 
questions to ask about our family members' care, and I knew 
where to go for answers to their care needs.
    Unfortunately, too often, this is not the case. Finding the 
way through a complex system of community services can be 
frustrating to families who are already overwhelmed by the 
challenges of caregiving.
    In working with families at the Alzheimer's Association, 
the saddest thing I have ever heard from a caregiver is: ``I 
wish I had known about these services when my family member was 
still alive.''
    The Alzheimer's Disease Demonstration Grants to States 
Program helps States to assure that community services are 
accessible and appropriate for the unique needs of people with 
Alzheimer's

[[Page 9]]

and their families. The initial program from 1992 to 2000 was 
created to address the needs of underserved families and gaps 
in community services. Twenty-nine States received funding 
through this program.
    With this funding, States were able to develop outreach and 
other services for underserved families in rural and urban 
areas and also diverse ethnic populations. The program also 
funded the development of a wealth of training materials for 
primary and long-term care providers of people with 
Alzheimer's.
    There is a current phase of the Alzheimer's grant program 
that has funded nine additional States, and the goal of this 
program is to integrate the dementia services that were 
developed into the mainstream home and community-based care 
system.
    Maryland has benefitted from this funding in both of the 
programs, and it has really made a difference for families 
coping with Alzheimer's. It enabled the four Alzheimer's 
Association chapters in Maryland to reach thousands of families 
who were not using services because they did not know they were 
available, or they did not know how to access them.
    The Western Maryland, Eastern Shore, and Southern Maryland 
sites targeted families in rural areas. These sites collaborate 
with other community agencies and help to connect families to 
services.
    Here in Baltimore City, we focused on outreach to African 
American families. This funding helped our chapter to establish 
three support groups targeted to African American caregivers, 
and it has resulted in increased participation of African 
American families in our services.
    The Maryland Alzheimer's demonstration grant has had a 
significant impact on the availability of services for 
caregiving families, and it essentially built the capacity of 
the Alzheimer's Association chapters to serve more people more 
effectively. It enabled the chapters to offer respite care 
subsidies to give families time off from caregiving. It 
increased the number of caregiver education programs to inform 
caregivers about the disease and how to access community 
resources. It provided for training of assisted living, nursing 
facility, home health agency and adult daycare staff to enhance 
the quality of care for people with Alzheimer's. It also helped 
the chapters train physicians and health care professionals in 
community clinics to encourage early diagnosis and intervention 
with treatments and services. Finally, it promoted 
collaboration among Alzheimer's Association chapters and public 
agencies to better coordinate care throughout Maryland.
    The Alzheimer's Association is currently participating in 
the Alzheimer's grant program through the Maryland Department 
of Aging, and Secretary Ward is here with us today. This 
program has two sites in the State in areas with limited 
caregiver services--the Eastern Shore and Southern Maryland. 
The funding has established a consumer-directed respite program 
for family caregivers. It is also strengthening the skills of 
health care providers through dementia training, and it is 
encouraging the development of new services by offering 
training to entrepreneurs on how to start and manage respite 
care services.
    Senator Mikulski, speaking on behalf of the Alzheimer's 
Association and the 85,000 Marylanders with Alzheimer's and 
their fami

[[Page 10]]

lies, I applaud your efforts to expand these programs through 
the Alzheimer's Disease Research and Caregiver Act. This bill 
will help to continue to ensure that no family faces this 
illness alone by providing essential accessible services and 
hope for the future.
    Thank you.
    [The prepared statement of Ms. Naugle may be found in 
additional material.]
    Senator Mikulski. Thank you very much for your testimony 
and for your advocacy.
    I am going to talk about the Alzheimer's Association in a 
minute, but I want to acknowledge that Sue Ward is here. Sue is 
the head of the Maryland Department of Aging, and all of us who 
have been involved in issues and services on aging really think 
she has been doing an outstanding job.
    Sue Vaeth runs the Alzheimer's Demonstration Program in 
Maryland, and she has submitted testimony for the record.
    [The prepared statement of Ms. Vaeth may be found in 
additional material.]
    Senator Mikulski. Sue Ward, I am not trying to put you on 
the spot, but as administrator of the program and the one who 
is handling so many of the information and referral calls, did 
you want to say anything or add anything?
    Ms. Ward. I believe that Ms. Naugle has said it all. The 
demonstration grant is very exciting for all of us, and we are 
all very pleased to be a part of it and certainly thank you on 
behalf of a variety of organizations.
    Senator Mikulski. Sue, I am going to ask you to join the 
witnesses at the table for when I ask the questions about the 
family--and again, I am not trying to put you on the spot--and 
you know I cannot put you on the spot. But when we speak of 
Alzheimer's as a disease, it does not exist in the vapors; it 
exists in the person, and it exists in the family and in the 
community. So when we are looking at the issues, again we are 
going to come to the research on treatment, but one of the 
biggest issues is those who have it now. Alzheimer's affects 
first the person who has it, the family who cares for the 
person who has it--it can be a spouse, it can be a parent--and 
it also affects the community.
    When we find the cure--and I believe that one day, we 
will--we will be able to reduce nursing home admissions and 
significantly reduce the costs to both families and the 
taxpayers.
    So I am going to focus now on the family issues, and the 
reason, Sue, that I asked you to come up is because you 
administer the Department of Aging, and one of the big issues 
is information and referral as well as caregiving.
    Mr. Savage, let me turn to you for a moment. You talked 
about Social Security being ``the villain.'' Could you 
elaborate on, first of all, the ability to find a caregiver and 
compatibility with your wife? These are all really very 
difficult issues, but Social Security should be an easy process 
for you. It is one thing that we should have literally in 
control--when so many things with Alzheimer's are out of our 
control.
    Mr. Savage. Well, it starts with you have to take a number, 
and you have to wait in line, and the person with Alzheimer's 
has to be there, because if anything has to be signed or 
approved, my wife

[[Page 11]]

has to be there to sign an ``X'' so that somebody can witness 
it; she cannot use a stamp.
    Senator Mikulski. Why were you turning to Social Security? 
Was it to apply for Social Security?
    Mr. Savage. It was to apply for disability, and the 
question was whether she had enough quarters to qualify for 
disability. And that has become a very contentious issue which 
is going to have to go through an appeal for which I will have 
to hire a lawyer to solve the problem.
    I do not know how much you want to hear about this.
    Senator Mikulski. Well, actually, I will want to hear more 
about it in a more private setting, respecting your family--but 
what I find troubling is not only the waiting time--that is a 
management issue--but let us go to the ability to sign papers, 
apply, et cetera. I have a power-of-attorney, I have a medical 
power-of-attorney; you try to plan and do the right thing.
    Mr. Savage. They do not accept that.
    Senator Mikulski. Do you have the power-of-attorney for 
your wife?
    Mr. Savage. I have power-of-attorney which was issued to 
me, and I had to bring my wife to sign everything and approve 
everything because they would not accept it.
    Senator Mikulski. This is really very troubling. In my 
family, my mother was the executor of my father's affairs, and 
I was kind of the administrative executive assistant to back 
them up. My father was already on Social Security, so we did 
not have to grapple with this. But this is a very troubling 
issue that you have raised.
    So your wife had to sign even though----
    Mr. Savage. She had to sign an ``X''; she could not use a 
stamp which we have. She cannot use that.
    Senator Mikulski. She cannot spell her name?
    Mr. Savage. She cannot write in the right slot, or legibly, 
so we now have a stamp which we had made for her so she can 
stamp things in somebody's presence--a check or whatever. So 
the caregiver can go to the store, and she can stamp the check, 
and everybody knows about it, so it is not unusual. But with 
Social Security, she has to sign an ``X'' in the presence of 
somebody from Social Security, so she has to be there, and it 
has to be explained to her, and that is complicated, especially 
after we have had a long wait, and she is getting antsy and 
impatient and wants to go to the bathroom. It gets to be a 
complicated issue.
    Senator Mikulski. I understand, and I find this very, very 
troubling. I want to assure you right now that first of all, 
when this hearing concludes, I am going to ask my staff to 
contact you and, in the appropriate private setting, we want to 
go over this, one, to see if we cannot help you get it 
straightened out as a constituent service, and second, if we 
can, I want to fully understand what you have been through as a 
case example for me to get into this with Social Security--and 
I am going to get into it with Social Security.
    Mr. Savage. Thank you.
    Senator Mikulski. You are a man of great experience, you 
are a well-educated man, you have financial resources, and you 
are a paperwork guy so you know how to organize yourself. I 
would say that 65 percent of the American people do not even 
know about

[[Page 12]]

power-of-attorney and many of these other things. So we want to 
help you and then, in helping you, in helping the one, we want 
to be able to help the many.
    Mr. Savage. I think the many are very important. And it is 
not that they were uncivil to me. They were usually civil, but 
they are not too quick in some cases. Just being able to pull 
things up on a screen--they could pull it up one time, but they 
could not pull it up the next time--so just getting to the 
records and giving you the information that you need to defend 
your own position was impossible.
    Senator Mikulski. But you know, the best advocate for the 
person is the family, and if the family has established the 
legal right to speak for the individual, you should be able to 
act on your wife's behalf to be able to do the appropriate 
things to get her the things to which she is entitled. That is 
where I am coming in, and I will come back to you.
    Cass, tell me about the Alzheimer's Association. Tell me 
what the Alzheimer's Association does. I think I know, but I 
would like to hear from you. And then, as executive director, 
what do people come to you the most about?
    Ms. Naugle. The Alzheimer's Association was created to fill 
in the information gaps and service gaps that families had. 
Back in 1980, families were essentially on their own; they had 
their doctor, but often they did not know very much about the 
illness; and they had nursing homes. Between that, the family 
took care of the care of the person without really too much 
support.
    So the Alzheimer's Association provides a help line that 
gives families information about the illness, about access to 
community resources, or anything that they need like support or 
anything over the phone. We provide respite care, because many 
of the services that people with Alzheimer's need are not 
covered by insurance or Medicare.
    We have a program called the Safe Return program, because 
many people with Alzheimer's can wander and become lost.
    Senator Mikulski. Yes, we have been a supporter of that 
program with you.
    Ms. Naugle. Yes. So we provide this program. We provide a 
lot of caregiver education and training to health professionals 
who provide care and also, of course, support groups throughout 
the whole State. Some are for people in the early stages, which 
is how Peter and Ina got involved with the Association. We have 
support groups just for spouses; we even have a group for 
Catholic nuns.
    Senator Mikulski. And those are Catholic nuns who volunteer 
to do research, the famous brain study.
    Ms. Naugle. Yes. So when people call the Association, it is 
for any variety of reasons. Usually it is, ``My family member 
is starting to act funny; what do I do about that?'' And then, 
after they get the diagnosis, it is, ``Where do I go from 
here?'' and we connect the families to services.
    Senator Mikulski. Where do you send them for diagnosis?
    Ms. Naugle. We have a listing of health care facilities 
that we know do a good workup and have a good understanding.
    Senator Mikulski. And they have an excellent geriatric 
evaluation program here.

[[Page 13]]

    Do you also use the Veterans Administration for older 
males, usually World War II veterans, and so on?
    Ms. Naugle. Yes. We have a wonderful connection with the 
Dementia Clinic that they offer at the VA in Baltimore.
    Senator Mikulski. After you explain the services--first of 
all, you do a good job, and I will come to Sue on that--what is 
the biggest surprise for families and that often adds to their 
sorrow--because this disease produces grief. As one loses 
cognitive ability, there is also the loss of the relationship, 
the loss of income. There is a lot of grief in this; am I 
correct?
    Ms. Naugle. Absolutely.
    Senator Mikulski. So there is the sorrow factor and, in the 
caregivers, even depression. But from the standpoint of public 
policy or public resources, what is often their biggest shock 
and biggest disappointment?
    Ms. Naugle. Their biggest surprise is that Medicare does 
not cover the services that they need, or they may have had a 
high option Blue Cross and Blue Shield for their whole life, 
but they find that that does not cover adult daycare or someone 
to help them in the home.
    So when families realize that most of those expenses are 
out-of-pocket, that is a big shock to them.
    Senator Mikulski. So issues like adult daycare, long-term 
care and even nursing home care; the big shock is that Medicare 
is not going to pay for it and that they will have to pay for 
it, as well as what we would call housekeeping services in the 
home to help--the kind of folks that Mr. Savage was talking 
about.
    Mr. Savage. It is even a tax deductibility issue. They are 
very strict as to what you can and cannot deduct; you have to 
be careful and look at the code pretty carefully. It is a real 
question.
    Senator Mikulski. Sue, as you run the Department of Aging, 
and you try to create a caregiver program and an information 
referral program, what are people coming to you for? When I say 
``you,'' I mean the Department of Aging and those that are in 
every county in the State. People do not realize that the 
Department of Aging is really the primary source of funds, 
along with local government, of the senior centers, which is 
usually the gateway for many people.
    Ms. Ward. Thank you, Senator, for inviting me to 
participate. We have submitted written testimony.
    Primarily, I think people come in order to get information 
about resources. As you know, 80 percent or more of the care 
that is provided to frail older people in the country is 
provided by the family, and most people can function, as Mr. 
Savage has, if they know where to go and what to do and receive 
some help.
    In my own family case, I have a grandmother, an aunt and a 
mother all of whom were demented. She was not eligible for 
Social Security at all, but it was the reverse mortgage that 
was my surprise, just for your information, because she could 
not apply and we had wanted to get a reverse mortgage to 
provide her care in her home as long as we could.
    Back to the question that you asked me, yes, they come 
primarily for information about resources. Obviously, the 
Alzheimer's Association is the primary resource for all of us 
to use----

[[Page 14]]

    Senator Mikulski. Do you contract with them?
    Ms. Ward. Yes, and in fact this latest demonstration grant 
is a joint venture. I think Cass got the earlier grant, and 
then we received this grant, and then we contracted with the 
Alzheimer's Association for part of that, as well as the area 
agencies. What we are trying to do, as Cass said, is develop 
more caregivers in rural areas where there are not the 
resources that people need to develop micro-enterprises to help 
people who have never necessarily thought of doing this to 
provide the care in the home as long as possible, and then to 
provide the respite services that are necessary for the family. 
And these providers can be family members.
    Senator Mikulski. In addition to the issue of a work force 
in the area of caregiving--because you need not only 
competency, which is skill-based, but the person has to truly 
be honest and reliable because of the vulnerability of the 
population----
    Mr. Savage. They have to have judgment.
    Ms. Ward. Yes.
    Senator Mikulski [continuing]. Exactly--and also 
compassion. I mean, this is not like being a cafeteria worker 
where getting folks through the line is fine; this takes a lot 
of very tender, loving care, again with a very vulnerable 
population.
    The federal government provides you with money for 
information and referral. Is the federal government doing 
enough to help you help the others?
    Ms. Ward. We would obviously like more staff in information 
and assistance, which is what we call it, because in addition 
to providing information, we try to help walk people through 
the process.
    Senator Mikulski. And it is very time-consuming.
    Ms. Ward. Yes.
    Senator Mikulski. And very difficult. People tell their 
stories anecdotally. They do not call and say, ``I want to know 
the resources and the regulatory framework for my spouse'' or a 
parent; they will usually say, ``My father is really not 
himself. Mother is doing the best she can,'' and then go on 
with their story. Am I correct?
    Ms. Ward. Absolutely. I think ``Father is acting funny'' is 
one of the primary explanations that people have for calling.
    Senator Mikulski. But do you think we have adequate 
services?
    Ms. Ward. Absolutely not--and I think Maryland does very 
well.
    Senator Mikulski. Where do you think the big service 
deficits are--and then I would like Cass and Peter to talk 
about it. What do you think are the service area deficits?
    Ms. Ward. Primarily, I think the amount of service is a 
problem, but also geographic areas. One reason we are 
concentrating on the rural areas is because if we think about 
the work force shortage generally in caregiving, rural areas 
are severely strapped in having people who are willing and able 
to do this, who can get the training to do this, and who have 
even thought of doing it. Many people who might want to start a 
business think of computers or crafts or something else. 
Caregiving is not necessarily something they think of, but a 
lot of these people are very experienced in caregiving. They 
have been doing this all their lives. And the opportunity to 
continue to do it and to get a little remuneration for it is 
extremely important, we feel.

[[Page 15]]

    Senator Mikulski. I want to switch gears now to the 
research. Peter, is Ina involved in a clinical trial?
    Ms. Savage. No. She is taking one medicine now which she 
would have to stop to involve herself in some of these tests. 
But through Dr. Lyketsos and Dr. Kawas and others, every time 
something has come along, we have tried to involve her.
    Senator Mikulski. But how did you hear about the clinical 
trials?
    Mr. Savage. Basically, when Ina was diagnosed at Shepherd 
Pratt, when we were then referred over to Dr. Kawas, he was 
engaged in several of the studies, so they quickly looked at 
her to see if she might fall into this one or might fall into 
that, might fall into the other. I was immediately engaged; I 
am a baseline study for God knows how many studies at the 
moment, so that any time something new comes along, including 
the recent vaccination, we try to get around to gatekeepers and 
get into a study. So through those contacts, we have been able 
to know what is going on.
    Senator Mikulski. What gatekeepers?
    Mr. Savage. For example, a company that was doing the 
vaccinations had 365 people in the total sample, and 25 percent 
of them were going to be given a placebo. I was trying to just 
get my wife to be considered for the study.
    Senator Mikulski. I am going to ask you a tough love 
question, because you are obviously a real fighter for your 
wife, and God bless you.
    Mr. Savage. Yes.
    Senator Mikulski. You are a real fighter--and thank you, 
Mrs. Savage.
    Then, I am going to ask about this also when we turn to our 
scientists. But you want to get anything you can to help her, 
which therefore means even circumventing the protocol; am I 
correct?
    Mr. Savage. You are absolutely right. What does it hurt?
    Senator Mikulski. We will come back to the protocol. But 
what it also brings up is your gateway to new knowledge or new 
resources and so on was because you got to the right area for 
geriatric evaluation. And again in my father's case, here at 
Bayview, there was a complete physical, a complete 
neurological, and a complete psychological, so we would then 
know if his medications were wrong and that was affecting his 
memory, or whatever. That then brought us to the team approach 
which is one of the signatures of the Mason Lord effort here.
    But whether you are in a rural area or not, the whole 
ability to get there is an issue. But it seems to be that the 
quality of the information is the trigger; am I right, Ms. 
Naugle?
    Ms. Naugle. Absolutely, just getting the information out to 
families. We try through every way possible, through the 
telephone, and we have a website where we have research 
opportunities that families can explore.
    Mr. Savage. I would also say that Dr. Kawas was excellent 
at using my wife as the poster girl for Alzheimer's for a 
while, because she was at one time quite articulate in a couple 
of languages, so she has appeared at board meetings where we 
have been trying to raise funds, and she has appeared in 
Baltimore Sun articles, and she has been in National 
Geographic, and she has been on an hour-

[[Page 16]]

long program in Brazil, where it is really an unknown disease 
in rural areas, and she appeared on ``Good Morning America.''
    All of that then drew information to us, because people 
discovered that we had a problem, and therefore, people would 
ask, ``Have you tried this?'' and we would go and look at that 
and then check it with Shepherd Pratt or with the Neurological 
Center here at Bayview to see if it checked out into anything 
which was responsible and which we should pursue.
    So I used all of those resources. Every time I would take 
an exam, I would get somebody's telephone number, and if I 
would hear something, I would call them.
    Senator Mikulski. God bless you. What really emerges is 
that, first of all, what is absolutely needed from a public 
policy perspective--and we are going to go to the research in a 
few minutes--but first of all, we really need people who are 
trained in this field. This subcommittee held a hearing last 
year on the shortage of geriatricians, people who are the 
primary medical caregivers, if you will, of older people, or 
who train people as to the adequate diagnosis, and then the 
ability to pay for that diagnosis.
    Then, there is the training of primary care physicians to 
be able to detect the signs of Alzheimer's to get patients 
diagnosed--because there could be any reason for symptoms--if 
you have had recent surgery, and you are on medications, you 
are going to be bewildered and have a memory loss or a memory 
deficit, but that is going to come back in a matter of weeks.
    Then, there is this issue of what Medicare pays for and 
Social Security; Medicare is a big factor in a family's lives, 
because there is a family expectation that Medicare is going to 
pay for this--am I right--and then information and referral.
    Mr. Savage. Yes.
    Ms. Naugle. Yes.
    Senator Mikulski. So we have a lot of work to do. When we 
hold our hearing on caregiving, I would like you to be able to 
come, because we are going to be talking about the States, and 
I would like you to be able to come, Sue, to talk about that 
area.
    Ms. Ward. Thank you, Senator.
    Senator Mikulski. We could spend our whole hearing on the 
issue of caregiving.
    The movie ``Iris'' for which one of the actors won an 
Academy Award tells the story of Iris Murdoch, one of the great 
writers of the 20th century, and a brilliant linguist, who 
herself moves to Alzheimer's. It is about the devotion of a 
husband, her own spunkiness and so on, and I think this movie 
is going to raise awareness.
    This is tough to face. The first thing is for families to 
face it, then to get the help they need, and then to make sure 
that government is on their side and is not adding to their 
hardship. And while government is trying to help with services, 
government has to help with the resources.
    We are going to go on to the research, but before we do, is 
there anything else you would like to sum up for me to take 
back to my colleagues on what we should think about or what we 
should do?
    Peter.
    Mr. Savage. Well, my wife is young and therefore does not 
qualify for Social Security generally because she is only 60 
years old.

[[Page 17]]

So that is a problem for younger people who face this issue, 
and it is more complicated. It is not just an issue of Social 
Security; it is an issue of what kind of support is available 
for somebody who does not fit a usual pattern.
    And I must say there are resources, and it is wonderful 
that there are resources, but some of them are not financial 
resources--it is your own imagination or somehow getting around 
the problems--and all of that has a cost. I guess I am blessed 
in that I can shoulder some of these responsibilities, but it 
would be nice to have some help.
    Senator Mikulski. Certainly. Good for you.
    Cass.
    Ms. Naugle. Again, Maryland has benefitted so much from the 
Federal funding that we have received to expand services, and 
it would be wonderful to be able to expand that to all the 
States in the country so there would be the same level of 
service for someone who lives here but is caring for someone in 
Minnesota.
    Senator Mikulski. So essentially take the programs 
nationwide instead of just demonstration programs--because 
every State is different; for our colleagues in the West, the 
geography makes a difference, the culture of the community, et 
cetera. I think that is excellent, and it is a goal of mine. 
Again, thank you for what you are doing.
    Sue.
    Ms. Ward. I think there is one other thing that we have not 
really considered but came to mind today because of something 
that Mr. Savage was saying. That is that in addition to the 
caregiving needs, the descendants of people who have 
Alzheimer's always have a worry--for me, it is a grandmother, 
an aunt, and a mother, so my children and I are already 
preparing for the possibility of my developing dementia as 
well. But that is something that we do not think of in the 
policy setting. We provide support groups, but do we really 
deal with that issue. I would like to see us include, at least 
in Maryland, something in the caregiving nature for helping 
that innate fear that descendants may have.
    Senator Mikulski. That is part of the research, too, on 
genetic proclivity.
    This has been excellent, and I want to say God bless you 
for your excellent advocacy, whether it is the family, 
community, or government. We really appreciate it.
    Ms. Ward. Thank you, Senator, for your advocacy.
    Ms. Naugle. Thank you, Senator.
    Mr. Savage. Thank you.
    Senator Mikulski. Let us hear from the ``genius club'' now 
and see what they want to tell us. We want research, we want 
magic solutions, and we want them now.
    We have two outstanding scientists with us today. Dr. Judy 
Salerno is Deputy Director of the National Institute on Aging. 
We need to recognize that the National Institutes of Health are 
located in Bethesda, MD, but this is a very unique campus in 
the sense that the National Institute on Aging is right here at 
Bayview. It is the lead Federal agency for Alzheimer's, and Dr. 
Salerno is an experienced researcher and an expert on geriatric 
care, and will tell us about her work. She has also served at 
the Department of

[[Page 18]]

Veterans Affairs, and I am the appropriator for the Veterans 
Administration, so I would even welcome your advice and 
insights on where we could also be using another Federal agency 
for breakthroughs.
    Dr. Salerno has her M.D. and her master's of science in 
health policy from Harvard, and we want to welcome her.
    Dr. Lyketsos, we also want to welcome you. Dr. Lyketsos is 
an associate professor of psychiatry at Johns Hopkins and is 
director of the Johns Hopkins Neuropsychiatry Service and 
Course Director for an ongoing series of continuing medical 
education programs on Alzheimer's dementia and care of the 
aging. He is the Baltimore site director of the Alzheimer's 
anti-inflammatory patient trial and is a principal investigator 
in many areas. We have been able to attract such outstanding 
researchers. And again, you have been a very strong advocate.
    Dr. Salerno, I am going to ask you to please present your 
testimony now.

STATEMENT OF JUDITH A. SALERNO, M.D., DEPUTY DIRECTOR, NATIONAL 
       INSTITUTE ON AGING, NATIONAL INSTITUTES OF HEALTH

    Dr. Salerno. Thank you, Senator, and thank you for inviting 
me to appear before you today to discuss Alzheimer's disease, 
an issue of considerable importance to every, single one of us.
    As a geriatrician and a physician specializing in the care 
of older persons, I would like to particularly thank Mr. Savage 
for sharing his story and reminding us of the human toll of 
this devastating disease.
    I first began as a clinical researcher at the intramural 
program at NIA in 1988. At that time, we rarely considered 
prevention or cure of Alzheimer's. A little more than a decade 
later, prevention and cure are the bywords of our research 
initiative.
    We have been able to identify a number of risk factors, 
both genetic and possible lifestyle factors, and are on the 
threshold of using powerful brain imaging techniques to help us 
improve our ability to diagnose Alzheimer's in its early 
stages.
    But most importantly, we are making significant advances 
toward effectively treating and hopefully even preventing 
Alzheimer's disease. NIA is currently supporting 18 clinical 
trials, seven of which are prevention trials. These trials are 
testing agents such as estrogen, anti-inflammatory, anti-
oxidant agents for their effects on slowing the progress of 
disease or preventing it altogether.
    We have recently initiated several clinical trials that 
build upon findings that focus on possible links between 
vascular disease and Alzheimer's. For example, as you 
mentioned, it has been widely reported that high blood levels 
of homocysteine, an amino acid commonly found in the blood and 
already considered a risk factor for cardiovascular disease, is 
associated with an increased risk of Alzheimer's. This is of 
great interest since blood homocysteine levels can be reduced 
by increasing intake of foliate, Vitamins B6 and B12.
    So we are supporting a clinical trial at NIH to look at the 
effects of supplementation on cognition in healthy men and 
women.

[[Page 19]]

    Other studies have indicated that the use of statins, the 
most commonly used cholesterol-lowering drug, may decrease the 
risk of developing Alzheimer's as well. A trial testing whether 
statins can slow the rate of progression in Alzheimer's is 
being launched this year.
    The Alzheimer's patient, we have come to realize--and we 
heard so eloquently discussed this morning--it is not only the 
patient with the disease, but the entire family unit. Most 
Americans with Alzheimer's disease are cared for at home by a 
relative, a spouse, an adult child, an in-law, or a friend.
    In addition to the financial burdens this imposes, 
caregivers frequently experience significant emotional stress 
and physical strain and often do not receive the support they 
deserve. Caregiving, as we know, is a 24-hour-a-day, 7-day-a-
week job. NIA has invested in REACH, a large, multi-site 
clinical trial to examine ways we can strengthen caregivers' 
ability and capacity to care for their loved ones. It is 
designed to help show us what works and at what cost.
    Another critical component of our research is translating 
basic science findings into clinical interventions. A very 
promising strategy has been the development of the vaccine 
approach to preventing or reversing the formation of amyloid 
plaques on the brain, amyloid plaques being the characteristic 
lesion of Alzheimer's disease. Human trials of an Alzheimer's 
disease vaccine were conducted by the Elan Corporation and not 
funded by NIH, but were halted earlier this year when a number 
of patients developed brain inflammation.
    Despite this outcome, the science on which the study was 
based continues to be a foundation for building safer 
strategies for arresting the progression of Alzheimer's.
    We have recently funded studies in conjunction with the 
Neurologic Institute to better understand the science 
underlying the vaccine approach. Fifteen years ago, we were in 
the dark about so many things we now understand about the 
biology and the genetics of Alzheimer's. Ten years ago, we 
could not model the disease in animals. But today, as you saw 
on your tour, we have transgenic mice who have been an 
invaluable tool for modeling Alzheimer's amyloid plaque 
development in the brain and for testing new therapies.
    Five years ago, prevention of Alzheimer's was a distant 
view. Now we have seven major clinical trials for prevention of 
this disease. It is difficult to know with certainty how the 
Alzheimer's story will turn out, but the pace of discovery and 
the progress we have made in recent years has been 
breathtaking. Our continued investment in Alzheimer's research 
will help us sustain the pace and advance our knowledge of safe 
and effective treatments and prevention strategies that really 
work.
    Thank you, Senator, for this opportunity to appear and 
report our progress.
    [The prepared statement of Dr. Salerno may be found in 
additional material.]
    Senator Mikulski. Thank you. We will come back and ask you 
some questions, but thank you.
    Dr. Lyketsos.

[[Page 20]]

 STATEMENT OF CONSTANTINE G. LYKETSOS, M.D., PROFESSOR, JOHNS 
HOPKINS UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, MD, ON BEHALF 
                 OF THE ALZHEIMER'S ASSOCIATION

    Dr. Lyketsos. Senator, good morning. I want to thank you 
for this very important hearing and for inviting me to testify 
and also for your staunch advocacy of the Alzheimer's cause.
    I also want to acknowledge the Alzheimer's Association and 
second what you have said about them, as well as the NIA for 
providing the leadership in the research effort.
    I also want to acknowledge several of my staff in the room 
from our clinical and research team who have taken the time to 
come today. They are the true workers on the research effort.
    I speak to you as a scientist and as a doctor who has taken 
care of many thousands of Alzheimer's patients, but I also have 
been touched personally by Alzheimer's in that my wife's 
grandmother suffered quite horribly from this disease, as I 
know many others in this room have been affected.
    You do make the point that we all support research as 
critical to the cure and prevention of Alzheimer's. Research is 
also critical to improving the lives of the 4 million victims 
currently. I want to remind you, as I am sure you know, that we 
lead, and the U.S. affects countless others with Alzheimer's 
around the world who are emulating what we do here, so there is 
a broader impact of this research.
    I strongly endorse the bill that you have submitted, the 
2000 Alzheimer's Disease Research, Prevention, and Care Act, 
and while I am delighted to hear about the $1 billion increase 
of NIA funds in general----
    Senator Mikulski. Now, we reached $1 billion--we did not 
add $1 billion. That is phase two.
    Dr. Lyketsos. I realize that, and that is where I wanted to 
go--hoping that the $1 billion in a few years will be dedicated 
to Alzheimer's research more specifically.
    Now, as a Hopkins professor, I want to point out that we 
are proud to be at the forefront of research and care. Our 
Memory Disorders Program for the care of patients with 
Alzheimer's, one of the first ever established in the United 
States, currently spans all the Hopkins institutions, both here 
at Bayview, at Hopkins Hospital, and at our affiliate at Copper 
Ridge. We have developed and provide not only diagnostic 
evaluations but ongoing care from diagnosis to the end of life 
for many thousands of people with Alzheimer's. I want to 
emphasize that already what we do in the care of patients makes 
a huge difference.
    But we are here to discuss research, and research in this 
area is hard to summarize. In my written testimony, I have gone 
into greater detail, and I am going to skip ahead to talk a 
little bit about what I see as the critical issues in treatment 
research.
    The most exciting possibility there that I want to 
illustrate relates to the possibility of preventing Alzheimer's 
that Dr. Salerno has already spoken about. This hinges 
primarily on the recognition that Alzheimer's is damaging the 
brain for many years--maybe decades--before it actually causes 
symptoms. An estimate has shown that if we can intervene during 
that time period, and if we

[[Page 21]]

can reduce or delay the onset of symptoms by 5 years, we would 
reduce the number of cases by half, which is a substantial 
impact. Therefore, NIA has initiated this effort.
    Our team at Hopkins is involved in three of the seven 
studies that Dr. Salerno mentioned, and the one that we are 
furthest ahead with right now and I want to talk a little bit 
about is the ADAP study, which is the Alzheimer's Disease Anti-
Inflammatory Prevention Study. Many of the staff members who 
are doing the work in this study are in the room.
    This study tries to recruit people 70 and older who are 
healthy seniors who have a first-degree relative with 
Alzheimer's. We already have at six sites around the country--
600 people. We have 120 here in town who are already enrolled 
in the study, and we have had great help from Secretary Ward 
and from the Alzheimer's Association in this recruitment 
effort.
    But I want to make the point that we need to eventually get 
2,400 participants, and given that we are talking about healthy 
seniors, one of the major efforts that we are hoping to get 
help with is the education of seniors about the availability of 
these research studies and the encouragement for them to 
participate. It is hard to encourage seniors to participate in 
these studies. The studies are expensive. I am sure you hear 
that a lot. It is expensive to do the research. But these sorts 
of studies take several years, many clinicians, and thousands 
of participants to give us answers about just a simple drug or 
two drugs, as we are looking at in ADAP.
    In addition to prevention studies, I want to emphasize 
other treatment studies. Drug discovery in particular, which 
these days is more of a collaboration between industry and the 
academic world, needs to be supported because that is 
ultimately what is going to bring us the cure.
    We also need to spend more time on the treatment of the 
noncognitive symptoms of Alzheimer's. We have shown through our 
research that as many as 90 percent of people with the disease 
develop what are sometimes referred to as ``psychiatric 
symptoms,'' which are very debilitating, including depression, 
delusions, hallucinations, and the like.
    Senator Mikulski. Is this prior to the onset?
    Dr. Lyketsos. No. This is after the onset. Through the 
course of the 10-year illness, 90 percent develop these 
symptoms. And research into how to treat those symptoms is 
really in its infancy. We have been doing a lot of it in my 
group, but I want to emphasize the importance of supporting 
that research further.
    We also do not want to limit ourselves to medication 
therapies. We are very interested in our group in non-
medication treatments for the patients as well as for the 
caregivers. Just to give you a few examples, we are working now 
with an exercise intervention to see if, through somewhat 
aggressive exercise treatment, we can reduce the progression of 
Alzheimer's disease. That study is funded by the Alzheimer's 
Association.
    We are also developing and researching a distance learning 
educational program to see whether we can train personal care 
workers through a CD-ROM interactive program in how to take 
care of people with Alzheimer's.

[[Page 22]]

    So research in those areas will hopefully improve the 
ability of people to give care day-to-day.
    Finally, there is the issue of delivering treatments where 
they need to be given. You have mentioned this morning the 
nursing home environment. We know that perhaps as many as 50 or 
60 percent of people in nursing homes have Alzheimer's, but we 
also have not known as much about the assisted living 
environment. My group is doing the Maryland Assisted Living 
Study funded by NIMH, the National Institute of Mental Health, 
and in our first early findings, we are discovering that as 
many as two-thirds of assisted living residents might suffer 
from Alzheimer's and that they are not receiving the sort of 
care that we would want them to receive. So improving the 
ability to deliver these treatments that already exist and the 
new ones that come out in these environments where millions of 
people with Alzheimer's live is an important mission.
    I want to summarize by expressing my deep appreciation for 
your inviting me to speak. We do know that this disease affects 
all of us personally, and there is a whole range of treatment 
and other research that is eventually going to need $1 billion 
a year hopefully to bring it forward.
    Thank you.
    [The prepared statement of Dr. Lyketsos may be found in 
additional material.]
    Senator Mikulski. Thank you very much for that outstanding 
testimony, but most of all for the work and the devotion that 
each of you have spoken with. Obviously, you are deeply 
involved in thinking about the lives of people with 
Alzheimer's, their activities of daily living, and their 
interactions with the people whom they love and who love them 
and, again, this great loss.
    You have been kind enough to mention the bill that I have 
introduced with Senator Kennedy and others. I was concerned 
that there needed to be a real focus on Alzheimer's research in 
the authorizing. Our colleagues on the Appropriation Committee 
which actually puts money in the federal checkbook are very 
good, but we developed this legislation called the Alzheimer's 
Disease Research, Prevention and Care Act. It focuses on 
prevention and authorizes research on caregiving, which is an 
area that is often not focused on, plus it is hard to measure, 
hard to evaluate, and so on, as well as keeping those 
demonstration projects going. And we do authorize the National 
Institute on Aging at $1.5 billion, so I anticipated what you 
would be asking.
    Let me now go to my questions. First of all, you 
acknowledged the people in the room who are your researchers. I 
think we should ask them to stand up and give them a round of 
applause.
    [Applause.]
    Senator Mikulski. We are glad to see all of you.
    Cass, do you have people with you from the Alzheimer's 
Association, the families and the advocates?
    Ms. Naugle. Yes.
    Senator Mikulski. Let us give them a round of applause as 
well.
    [Applause.]
    Senator Mikulski. Very good, very good. This is very 
dynamic.

[[Page 23]]

    I want to ask some questions now. When we talk about 
prevention, Dr. Salerno--and seven of the clinical trials are 
here--not only what advice would you give to us in terms of 
funding the research, but what advice would you give families 
now in terms of just general prevention? Do you think it is 
diet, exercise?
    Dr. Salerno. I think we are on the threshold of 
understanding those issues, but as far as practical 
information, as we talked about before, increasing foliate in 
your diet certainly does not hurt, and exercise leading to 
understanding and prevention of associated diseases like 
hypertension and diabetes. We have a lot of information about 
that, and the interplay of those factors is something that we 
are just beginning to understand.
    Senator Mikulski. Let me ask about that, because it goes to 
something that Mr. Savage identified, which is how do you get 
the medical treatment for someone who has Alzheimer's. We think 
of someone who might be 72 years old, and they have Alzheimer's 
and diabetes and are insulin-dependent--no neuropathy signs, 
but they have to take insulin--this is a difficult patient 
management issue, first of all in terms of just remembering to 
take your insulin, to keep track, to do the blood work and so 
on. Where do people turn, and what kind of research is actually 
going on to be able to deal with these issues?
    Dr. Lyketsos. I think you have hit upon a critical point. 
The Alzheimer's patient rarely has just Alzheimer's, and it 
might be diabetes, it might be heart disease or hypertension; 
on average, there are two or three other conditions for the 
typical patient.
    Here in Baltimore, where I am fairly familiar with the 
scene, the groups such as ours at Hopkins Bayview that 
specialize in this area are overwhelmed by referrals because 
there is very little training and availability elsewhere.
    Senator Mikulski. Who is referring?
    Dr. Lyketsos. Lots of sources--the Alzheimer's Association; 
the families hear about us from word-of-mouth; the NIA; our 
colleagues in primary care with whom we have worked over the 
years. We are typically backed up several months because we do 
not have the staff to handle the kind of need that is out 
there. We have been trying to grow the programs very slowly 
around town, but there are not many clinicians who are 
interested in going into this area. It does not pay as much; it 
is hard work; there is a lot of after-hours work, and it is 
frankly very difficult to take care of people with terminal 
illnesses who are declining for many years.
    Senator Mikulski. You bring up some very important points. 
Number one, I am just appalled at the really skimpy 
reimbursement to primary care physicians taking Medicare 
patients--just Medicare patients. When you add to that the 
complexity--first of all, the older you are, you usually have 
more things that you are coping with, you have more drugs that 
you are dealing with, and these are important tools for 
survival. Yet that physician out there, whether it is in 
Highlandtown or Locust Point or Timonium or Bel Air or Bethesda 
or wherever, is listening to the patient--first of all, you 
have to really listen--and then, you are managing multiple 
diseases and multiple drugs. If you then add a memory loss 
issue, and if that person does not have a competent caregiver, 
that even compounds it.

[[Page 24]]

    So I think one of our issues is that you cannot be an 
expert everywhere. There are just not enough of you. Just like 
there are not enough geriatricians to do this--but the teaching 
of those involved in internal medicine who, demographically 
have large populations of the elderly--I think we need to 
reimburse them so they will have the time to listen and 
practice the medicine they want to do. Then you all essentially 
train the physicians so they can do broader-based care.
    Is that really a very important public policy?
    Dr. Lyketsos. I think it is. I would want to follow up and 
go back to something you said earlier, that it is really a team 
that we need to reimburse. There is a physician, but there is 
often a nurse, a social worker, an occupational therapist--many 
times, there is a broader team.
    Senator Mikulski. Or a nutritionist.
    Dr. Lyketsos. Or a nutritionist. It is a team care 
approach, and Medicare really limits who it will pay for 
Alzheimer's-related services.
    Senator Mikulski. Dr. Salerno.
    Dr. Salerno. I would add that we have to ``gerontologize'' 
all of the health professions, that we are never going to have 
enough people with a specialty in this area, and that we really 
have to give them the tools to be able to care for a broader 
range of folks. It really is very much absent in the training 
of most health professionals, and we need to do more to provide 
the training and the tools.
    Senator Mikulski. So that while we are doing research, we 
really have to put emphasis on training and the training of 
all--what was the phrase you used?
    Dr. Salerno. ``Gerontologize.''
    Senator Mikulski. Gerontologize. If you can say it, we 
ought to be able to fund it. [Laughter.] So you are saying 
across the board in all other training--because somewhere along 
the line we are all going to get old; that is part of the 
predictable behavior.
    Let me come back to research. Dr. Salerno, what areas of 
research do you think show the most promise?
    Dr. Salerno. I certainly think that we have shifted into 
the prevention mode, and I think that understanding the disease 
and the underlying pathology has given us great opportunities 
to look for drugs that work, and knowing the mechanisms, we can 
see where along the line we can intervene, whether it be in the 
amyloid plaque production and also in nonpharmaceutical 
approaches, as we heard a few minutes ago.
    I think that prevention is really the key now and looking 
at the disease much earlier than we used to, and that is the 
progression from a normal, cognitively healthy person to those 
whom we call mild cognitively impaired to see who will go on to 
develop Alzheimer's disease--looking at the entire spectrum as 
we go through that.
    Senator Mikulski. So early detection----
    Dr. Salerno. Absolutely.
    Senator Mikulski [continuing]. Which really comes from 
early observation, it goes to making gerontology part of the 
basic train

[[Page 25]]

ing, if you will, of internal medicine and so on, where they 
begin to see the early signs.
    Dr. Salerno. And then we can intervene earlier and perhaps 
delay that onset or stop it altogether, and that is really the 
promise of the research that we are doing now.
    Senator Mikulski. Let me ask you about complementary 
medicine. I notice in the seven trials that, in addition to 
estrogen and so on, you are looking at ginkgo biloba, which you 
see advertised in every vitamin store that it will help you 
with your memory.
    You need to know that I am a believer in the field of 
complementary medicine, but I also want to protect my 
constituents from quackery. That is why I joined with Senator 
Tom Harkin to establish an Office on Complementary and 
Alternative Medicine at NIH to be able to do the research.
    When people are desperate, they will go anywhere and do 
anything, from wearing copper bracelets to putting garlic on 
their earrings. I do not want to trivialize the field, but 
there are legitimate complementary modalities--and I am glad 
you are doing this research--as well as those who will exploit 
the vulnerabilities of people.
    First, are you doing research in those areas, and do you 
have any observations or comments that you would like to make 
about that?
    Dr. Salerno. Yes. Ginkgo is one of our largest clinical 
trials to date, and I think it is important that we look at 
these issues and these interventions in a systematic way so 
that we can get real answers. I think the potential for harm 
even in some nutritional therapies that are advocated by the 
anti-aging folks--and I am anti-aging, but I am certainly----
    Senator Mikulski. Are you talking about ``The Wrinkle 
Cure'' stuff?
    Dr. Salerno. Yes, but certainly we need to do this safely.
    Senator Mikulski. We all buy the books.
    Dr. Salerno. I visited my mother last weekend in New York, 
and she has a whole pharmacy on her night table, and I went 
through and said, ``Do not take this, do not take this, take 
this''--it just shows you that these are our most vulnerable 
people and people who often do not have a lot of resources to 
spend on these cures that do not work.
    So the research that we are doing is to give us answers and 
give the public information that we have to get out there when 
we have the answers, both to health professionals and the 
public. I think that is very important in getting the message 
across about what is safe and what is not.
    Senator Mikulski. Well, two things--first, I agree with 
you, and I hope there is collaboration going on with the Center 
for Complementary and Alternative Medicine. Under President 
Clinton, there was a White House Commission on Complementary 
and Alternative Medicine, and their report will be coming out, 
which I think will be very important information that you can 
use.
    Let me go to the non-medication issue. We know we are doing 
research on those things where there could be a drug for the 
cure, but most of all, a cognitive stretch-out. As you said, 3 
to 5 years can make all the difference financially, 
emotionally, and so on. But

[[Page 26]]

you have also talked about the non-medication research. Could 
you elaborate on that for us, Dr. Lyketsos?
    Dr. Lyketsos. Sure. Those of us who have been taking care 
of patients for many years have realized that there are many 
strategies that make a difference in their lives and in the 
lives of caregivers, and the research is now showing that that 
is not just a difference in quality of life, but it impacts on 
outcomes like institutionalization. So a team in New York a few 
years back showed that a very structured education program for 
the caregiver will delay institutionalization by about a year 
or two.
    There is some other promise that we are hoping to find that 
exercise interventions in middle stages of the disease, before 
the motor symptoms happen, would improve the functional course 
and also delay institutionalization.
    Activity interventions might have a lot to do with 
preventing behavioral problems that occur, agitation that many 
of the patients experience.
    Senator Mikulski. What kind of activity?
    Dr. Lyketsos. Basically, structuring the day with something 
to do, and it probably matters less exactly what you do; it 
matters more that you do something, rather than leaving the 
person unoccupied where, in addition to deconditioning their 
body, they decondition their mind.
    So those are the kinds of things that could make a big 
difference. A point that I often make when I lecture is that 
the evidence is there already that those interventions in terms 
of bang for buck have as much success as some of the approved 
medicines that we have on the market in terms of delaying, say, 
institutionalization, helping life quality. If we put the two 
together, it can only improve the mix.
    Senator Mikulski. What is interesting to me, in addition to 
looking for the medications, is looking for the genetic 
therapies for those who might have a family history. They are 
so promising now that we have new ways of measuring the brain, 
new ways of developing the protocols, and these mice that help 
us to learn things faster. Essentially what both of you are 
saying is that the things that would keep anyone healthy are 
those things that can be helpful--a diet that is low in fat, 
big on vegetables and fruits. When in doubt, eat something 
green, and if you are still in doubt, eat something greener, 
because that provides the folic acid. All those things that our 
mothers told us--eat your spinach, eat your kale, pizza is not 
a vegetable--as well as exercise are important. It would then 
seem to me that as you are working on this, if people looked at 
other associations like heart disease, diabetes--the 
associations are all recommending the same things.
    This also goes to education. If I may say, every doctor you 
go to for just about anything you have will tell you that you 
need a reasonable diet, and you need to exercise, and they 
usually have nothing else to tell you after that. So, how do 
you do exercise?
    My mother, who had diabetic neuropathy, learned exercises 
to do in her home, and she was faithful in doing that: using 
her wheelchair, walking back and forth on some plastic that we 
put down to keep those legs moving, one-pound weights that she 
could use at home, leg lifts--all those practical tips. You are 
not going to use

[[Page 27]]

a primary care doctor to do this teaching. This then goes to 
public education in many ways, because it is different exercise 
for different groups, some homebound. But again, this could 
even be part of the structure of the day; am I right?
    Dr. Lyketsos. Absolutely, yes. In fact, I want to point out 
that Laura Poterwels, who is in the room, with our group is a 
graduate student in our school of public health and is an 
exercise physiologist who is developing an Alzheimer's-specific 
intervention program as part of the research.
    We are not sure yet how to do this, how to develop the 
exercise intervention for the person with Alzheimer's disease, 
because you have to take into account their memory impairment, 
the availability of the caregiver to help them, and so forth. 
So it is a really critical issue.
    Senator Mikulski. Well, first of all, so much has happened 
since we came here on that very melancholy day when we knew 
that our father was changing--that was in 1985, so one can get 
a sense of the progress; it has been almost 20 years. Then, 
there was care and compassion, and I know that through the 
adult daycare program here, the structure that it provided, 
even though we were faithful at home, was a different type of 
structure. Mother at times needed a breather from him, and he 
needed a breather from her. And this was great, but even 
compared to where we were 3 years ago, looking at behavioral 
issues, diet, exercise, genetics, pharmaceutical solutions, 
this multi-pronged approach is really so far advanced. And when 
you think about what the whole Institute is doing for 
essentially less than $1 billion a year, I think the American 
taxpayer should know that we are really getting value for our 
public investment. There is strong science here, but it is 
science with practicality and compassion, and that is really 
outstanding.
    Do you have anything else you would like to tell me, just 
open-ended, about what we should be doing. You see, this 
becomes a permanent record of the United States Senate's look 
at what we should be doing. Do you have anything else that you 
would like to share with me?
    Dr. Salerno. I would just like to say that any funds that 
we get for research I can guarantee that we will invest wisely, 
because there is a lot that we can do, will be doing, and I 
think we have the long view of research, and that is that we 
are going to find a cure, and we are going to prevent this 
disease, and that it may not happen tomorrow, but it will 
happen.
    Dr. Lyketsos. One point that I want to emphasize again to 
you, Senator, is the importance of teaching our seniors about 
research participation. That is probably one of the biggest 
barriers that we face in the field is all the education we have 
to do every time with every senior.
    I gave the example of the ADAP study, where we ask seniors 
to come in and take a pill every day that might have an anti-
inflammatory in it, and they might have to do this for 5 years. 
Julie Pedrosa, who is our coordinator and also here today, has 
groups of seniors 20 at a time where she spends a long time 
discussing what research is about.

[[Page 28]]

    So educating our public that this is the research that 
needs to happen and encouraging them to consider participation 
will make a big difference.
    Senator Mikulski. What are the barriers?
    Dr. Lyketsos. There are many barriers. One is their 
suspicion about research.
    Senator Mikulski. They do not want to be guinea pigs.
    Dr. Lyketsos. They do not want to be guinea pigs. And that 
is particularly true among some of the communities that have 
been badly affected by research.
    Senator Mikulski. Yes. The African American community 
remembers Tuskegee.
    Dr. Lyketsos. Right. So that is one big barrier. Another 
barrier is the concern about the risks of being in research. If 
you are talking about treatment research, there are side 
effects to medicines.
    There has been a lot of bad press over the last year or two 
about research, especially in the Baltimore area, so that does 
not help a lot.
    So there are many barriers, and if we can educate our 
public amongst the seniors that ultimately, it is going to come 
down to them being in the studies, that that is how the 
prevention work will be able to succeed in answering the 
questions.
    Senator Mikulski. But you know, Doctor, I get calls in my 
office from people who are desperate, not only in this field, 
but cancer patients, patients with advanced diabetes, and very 
often patients with some form of pediatric cancer. People are 
desperate to get into the clinical trials. They call me as if 
it is a political perk rather than coming in--but they come so 
late, and after everything is exhausted, they look to a 
clinical trial to be, if you will, their final solution or 
their final grasp. So I do think there needs to be more 
education about it.
    Now, before I wrap up, I would not be me, in Highlandtown, 
if I did not do what I used to do when I was a Congresswoman. 
When I was a city councilwoman, and I would come out to the 
neighborhoods here, and when I was a Congresswoman, we would 
always have town hall meetings where you could ask me 
questions, I could ask you questions back, or if you wanted me 
to ``Give them hell, Barb,'' at city hall, whether it was 
William Donald Schaefer or someone else. President Reagan was 
always particularly mesmerized by what I told him constituents 
would say. If there is anybody here who would like to ask me a 
question or something that you would like me to take back to 
Washington to tell my Senate colleagues and even the White 
House.
    Yes--and please identify yourself.
    Ms. Boswell. My name is Tara Boswell, and in addition to 
working as a facilitator for the Alzheimer's Association, I 
work in adult daycare. One of the questions and concerns that I 
have is that medical assistance does not recognize Alzheimer's 
as a legitimate need for medical daycare, and a lot of people 
are turned away who could really benefit from the structure and 
socialization that the doctor was talking about. So that was 
one thing that I was hoping you could take back with you.
    Senator Mikulski. Very good. That is an excellent point.
    Anybody else? Yes?

[[Page 29]]

    Ms. West. I am a facilitator for the Alzheimer's 
Association also, and I had a problem with the power-of-
attorney for my aunt. The lawyers suggested that my cousin get 
custody rather than power-of-attorney, and it worked out better 
for him for that particular reason.
    But I would also like to know about people who have to 
leave their jobs to take care of a person or a family member 
with Alzheimer's. There seems to be no support out there for 
them, no medical insurance for them, and that is also a 
problem.
    Senator Mikulski. What is the issue--loss of an income?
    Ms. West. The loss of income, and when they try to get 
medical assistance for themselves, they are told, ``That is 
your choice; you chose to stay home and take care of that 
person,'' when there was no one else there to take care of 
them.
    Senator Mikulski. May I ask your name?
    Ms. West. Shirley West.
    Senator Mikulski. Ms. West, when we hold our hearing on 
caregiving, this is one of the issues that we want to bring 
out. We have been talking about this because again, caregiving 
is also a tremendous loss of income, or in families where they 
take a part-time job, it is usually the women who do this.
    Second--let us just say it is a daughter helping out a 
parent. I will use that as an example--it affects her income, 
it affects her own Social Security in the future, and it also 
means that if you are part-time, you cannot get health 
insurance unless you go the individual route, and then it costs 
you $6,000 or $7,000--and if you could afford that health 
insurance, you would not worry about it in the first place.
    Am I on the right track?
    Ms. West. Exactly.
    Senator Mikulski. Well, thank you. You bring up a very good 
point, because we have to find a way to acknowledge 
particularly those who take a step-down in their own income to 
be able to help their families.
    In another administration, when I was working with Vice 
President Gore, we were looking at the Social Security issues 
for both homemakers and caregivers because of their loss of 
income. It was like a ``Mommy tax,'' and the better the 
daughter, if you will, she was penalizing herself.
    So we want to come back and look at that, and you raise a 
very good point. Thank you for bringing it to our attention.
    Anybody else? Yes?
    Ms. Sigurdson. Senator, my name is Kathy Sigurdson. I am a 
former caregiver of my husband who had Alzheimer's. To me, it 
is very important to have support for the caregivers. It is 
important to have more research funds to find a cure and more 
support for the caregivers for the Safe Return Program. My 
husband was lost for 90 minutes. The caregiver support program, 
the daycare, was very important to me because I could 
concentrate on work and know that he was safe for 8 hours.
    Senator Mikulski. I am sorry--what is the thing that is 
important to you?
    Ms. Sigurdson. The daycare.
    Senator Mikulski. The adult daycare.

[[Page 30]]

    Ms. Sigurdson. Yes. I was able to go to work knowing that 
he was safe for 8 hours.
    Senator Mikulski. And not only safe, but getting the 
support and encouragement that he needed.
    Ms. Sigurdson. Yes, yes, and the structure that he needed. 
So the caregiver support program is very important, Safe Return 
is very important, and money for research--hopefully more than 
$1 billion.
    Senator Mikulski. Thank you for your eloquence. Thank you.
    Anybody else?
    Mr. Savage. Get campaign reform in place and make it work.
    Ms. Ward. Senator, there is another barrier that seniors 
have to participating in research, and that is that they want 
to know whether they are in the control group or----
    Senator Mikulski. They want to know if they are on the 
placebo.
    Ms. Ward. Exactly.
    Senator Mikulski. But then, it is not a placebo if you know 
you are getting it. The placebo is the belief that you are 
getting it.
    Ms. Ward. Yes, but they do not want to participate if they 
are not going to get help, and that is another barrier.
    Senator Mikulski. And that is one of the challenges of 
research; it really is. But I think we are an informed public, 
and also, I think there are also generational differences. I 
think that younger people as they are coming along are more 
interested. But this is it.
    It seems, though, that we have to work on the cures; then, 
we have to work on those who are part of a team, whether they 
are social workers, doctors or nurses, to really understand, 
first of all, the normal processes of aging so you can know 
what is not going well; and then, as they are able to identify 
it, to get people on the right track; and then, we really have 
to pay people. We really have to pay doctors, we have to help 
the nurses, et cetera. So we have some big challenges.
    I want to ask the exercise lady to tell me what you are 
doing.
    Ms. Poterwels. I am currently working on a Ph.D. in public 
health at the Hopkins School of Public Health, but Dr. Lyketsos 
and I are working on exercise trials. This is a small pilot 
trial where half of the people will get a home-based exercise 
intervention which involves the resistance bands and personal 
instruction as well as pictures of each exercise, so that 
hopefully, they cannot really go wrong, and personal attention. 
The other half will get a home safety evaluation and 
recommendations for improving that.
    We are hoping to at least improve the functional ability or 
at least maintain the physical function and activities of daily 
living of these people.
    Senator Mikulski. What are you looking at, though? Are you 
looking at what exercises might improve cognitive ability? Are 
you looking at how to get older people in an exercise program 
and have them stick with it?
    Ms. Poterwels. We are actually just recruiting Alzheimer's 
disease patients, so it is only going to be those who have a 
caregiver that is with them for at least 10 hours a week; and 
we will be doing this home-based exercise program and looking 
at the beginning and at the end for cognitive outcomes, 
behavioral outcomes,

[[Page 31]]

as well as physical functioning to see if it improves or 
maintains that.
    Senator Mikulski. Yes, Dr. Salerno.
    Dr. Salerno. I would just like to add that the NIA has a 
major campaign for the promotion of exercise among all older 
people, and we have a free booklet that you can get by going on 
line, and you can get the telephone number on our website or 
call our Alzheimer's Disease Education and Referral Center. It 
tells you how you can safely in later age exercise and keep 
yourself health.
    Senator Mikulski. I am a big believer in videos, and I 
would love to know from all of you if it is included in the 
funds to get the information out, because sometimes the ability 
to put out into the public what we have already learned is 
critical--things that are so practical--we have got to find 
better ways of doing that.
    The great thing about a video is that the caregiver can 
come in and watch it, but so can the 15-year-old niece or 
nephew who says, ``I am going to do this with Grans or Pops,'' 
and turn it into a fun thing, rather than everybody being 
gripped with sadness or feeling helpless. This is not the 
grandfather you used to go fishing with, and what can you do? 
Well, maybe it is playing hoops from your own living room--
speaking of the Terps these days.
    Dr. Salerno. We have a video, too.
    Senator Mikulski. Good. I would like to see that video.
    I know my staff is going to start handing me these little 
blue cards that tell me it is time to wrap it up. But first of 
all, I want you to know that I have found this conversation 
very informative and very instructive for all who participated, 
but I also want you to know that I found it very inspirational. 
I am really inspired by the dedication of American families to 
the people they love. You know, we do a lot of analyzing of our 
society about what is right, and maybe it is not the way it 
was, but just listening to you, I know there is a tremendous 
amount of dedication, as well as among the scientists and the 
clinicians and all of their work. You have really inspired me. 
You have really energized me. You have really encouraged me to 
eat more folic acid, to ``Go green,'' and get my own exercise 
program.
    So just know that when I am in Washington, I will never 
forget you. God bless you.
    [Additional material follows.]

[[Page 32]]

                          ADDITIONAL MATERIAL

                 Prepared Statement of Peter V. Savage
    Ina Dutra Savage, born in Rio de Janeiro, Brazil in 1941, came to 
the U.S. for the first time to attend high school as an international 
exchange student in 1958. After graduating from Mineola High School, 
she returned to Brazil to attend the Catholic University of Rio, where 
she got a degree in sociology and became an associate teacher at the 
university. Because of her linguistic ability--she spoke Portuguese, 
French, English and Italian--she was hired by the U.S. Embassy to serve 
as a social secretary assigned to the U.S. Ambassador, Lincoln Gordon. 
In this job, she met her husband, Peter Savage, and they were married 
in 1967. She was assigned with her husband, a CIA officer, to Brazil 
and, later, Argentina, returning to the U.S. in 1978, with her husband 
and three daughters. When her children were of school age, Ina enrolled 
in a Master's Degree program for linguistics at University of Maryland, 
graduated in 1988 and was licensed to teach French and Spanish in the 
Baltimore public school system in 1990.
    The first sign of any difficulty for Ina was her apparent inability 
to remember her teaching program in classes and her inability to 
maintain class discipline--both very much out of character. In 1991, 
she had to resign as a teacher and signed up as a translator/
interpreter for Spanish, French and Portuguese. Other lapses and 
orientation problems appeared and, in 1993, she was referred to a 
neurologist. After more than a year of exams, observation, and tests it 
became apparent that there was a progression to her ailment and she was 
referred to Shepard Pratt for more analysis. After long study, she was 
diagnosed with Alzheimer's disease in October, 1995. At that point, the 
impact on the family began to be felt.
    The first problem was that Ina could no longer drive a car, so that 
getting kids to and from school, shopping, and daily activities were 
shifted to her husband or older daughters, two of whom were off at 
college. The Alzheimer's Association was helpful in identifying support 
groups where others could point the way to the problems we faced. An 
elder care lawyer had to be identified, our wills and living wills had 
to be drawn up), and we had to plan for our future finances to deal 
with an uncertain future with an uncertain timeframe.
                    immediate and pressing problems
    The immediate concerns following the diagnosis were:
     Where could Ina's husband, Peter, find a job that allowed 
flexible time for him to deal with the family chores Ina could no 
longer perform?
     How could we get health insurance that could avoid a pre-
existing condition exclusion for the Alzheimer's?
     Where should we go for medical attention to the immediate 
manifestations of a disease that was, probably, Alzheimer's?
     What resources were available to support any of these 
decisions that had to be made?
                           long term problems
    Longer term problems also loomed and needed consideration in the 
short term:
     If institutionalization were the likely end of the line 
for Ina, how would she qualify for Medicare and Medicaid?
     Social Security had not recognized several years of Ina's 
independent contractor work and, accordingly, disqualified her time 
necessary to qualify for benefits. How to deal with this?
     What were the roles that each member of the family would 
take on as Ina's abilities declined?
     Who are the lawyers, accountants, brokers, psychologists, 
and support groups who can help sort out these questions?
    None of these questions has a definitive answer that suits every 
family. Certain it is, however, that when a mainstay of a household 
becomes incapacitated--becomes a vegetable--the world of a family is 
stood on its head. And if there are insufficient financial resources to 
meet unexpected needs the impact can be ruinous and relationships 
within the family unbearable.
    While some of these questions remain unresolved, there were answers 
for the short term--pressing questions. Peter got a real estate license 
and became a commercial broker so that his hours were flexible and he 
could tailor work around family demands.

[[Page 33]]

    The family became an incorporated entity where all, including Ina, 
were salaried employees or dependents, so that, under Maryland law, a 
health insurer could not deny coverage by reason of pre-existing 
conditions.
    Shepard Pratt referred us to Claudia Kawas, a neurologist 
conducting various tests for new drugs aimed at Alzheimer's disease at 
the Bayview Neurological Center at Johns Hopkins, who introduced 
various courses for enrolling in new clinical trials. Staff working 
with Dr. Kawas were helpful in assessing how our resources should be 
allocated in meeting the crisis. They recommended a book, ``The 36 Hour 
Day,'' by Dr. Peter Ravens (and others). This book was indispensable 
reading.
    In addition, Dr. Kawas was in a position to diagnose Ina's 
situation to see which study might be most suited to her treatment. In 
the end, however, Ina would have had to discontinue taking drugs which 
had proven beneficial (donepezil) to qualify her for several of the 
studies being conducted by Dr. Kawas or for other studies being 
considered in the field. Ina is presently involved in a long term study 
measuring the progression of memory disorder at the Bayview Research 
Center and has donated her brain on her death, to Johns Hopkins.
    Her present doctor, Vassilis Koliatsos, of Shepard Pratt 
Neuropsychiatry Program, has also kept us current on new clinical 
trials under consideration and advised us on what courses to consider. 
Ina volunteered for the positron emission tomography (PET) study at 
Johns Hopkins but, again, she would have had to stop taking donepezil 
for a 6-month period prior to the study.
    Dr. Constantine Lyketsos, of the Johns Hopkins Neuropsychiatry 
Service was very helpful in getting Ina around the gatekeepers to the 
ELAN/EN1792 vaccine study at the Mayo Clinic last September, but her 
mini-mental scores were lower than the candidates permitted in the 
sample. This test was ended abruptly and her non-participation was 
probably a grace.
    Most of the longer term problems have still to be resolved, but the 
most aggravating part has been dealing with the bureaucracy at Social 
Security who have been so unhelpful that a lawyer has had to become 
involved at considerable expense.
    The roles of family members are still being resolved. Ina now 
requires caretakers 24 hours a day, so the daughters have advertised 
for caretakers, interviewed them, made a schedule and coordinated it so 
that Peter can have his work day free to go to the office and have 
weekend activities out of the house. One daughter acts as a caretaker 3 
days a week and Peter is on duty nights and weekends.
    The long-term prospects are still clouded by Ina having to qualify 
for disability and Medicaid within the time that she may require 
permanent institutionalization. In addition, the family has been 
challenged by the difficulty in finding appropriate activities to keep 
Ina stimulated as the disease has progressed. Each case of Alzheimer's 
disease affects the family and the individual differently. Services and 
supports that are utilized by one family or individual may not meet the 
needs of another.
    Senator Mikulski, I thank you for inviting me to speak at this 
hearing and for the opportunity to discuss how Alzheimer's disease has 
affected the Savage family.
                   Prepared Statement of Cass Naugle
    Senator Mikulski and honored guests, I am pleased to have the 
opportunity to discuss the impact of the Alzheimer's Disease 
Demonstration Grants to States Program. This program was created in 
recognition that Alzheimer's disease affects 4 million Americans and 
that most of their care is provided in the community by family members. 
The goals of the Alzheimer's Disease Demonstration Grants to States 
Program are to increase the availability of supportive services for 
people with Alzheimer's and their caregivers, and to assure that these 
services are effectively coordinated.
    In addition to working as executive director of an Alzheimer's 
Association chapter, I have experienced this disease first-hand. First, 
my father's sister, who helped raise me, developed Alzheimer's, then my 
mother's younger brother. My father was also diagnosed. We cared for 
him at home for 3 years until he passed away last June. Now my mom, my 
hero, is a victim of this disease. Using adult day services and in-home 
caregivers, my siblings and I are able to keep her in her home, which 
is very important to her at this point. This is the home where she was 
born, where she raised eight children, where she lived with my father 
for 62 years.
    As difficult as it has been to lose people I love to this disease, 
I know my family was fortunate. I knew what questions to ask about our 
family members' care and I knew where to go for answers to their care 
needs. Unfortunately, too often this is not the case. Finding the way 
through a complex system of community services can be frustrating to 
families already overwhelmed by the challenges of caregiving.

[[Page 34]]

As executive director, the saddest thing I have ever heard from a 
caregiver is ``I wish I had known about these services when my family 
member was alive.''
    The Alzheimer's Disease Demonstration Grants to States Program 
helps States assure that community services are accessible and 
appropriate for the unique needs of people with Alzheimer's and their 
families. The initial program in 1992 was created to address the needs 
of underserved populations and gaps in community services for people 
with Alzheimer's. Twenty-nine States received grants through this 
program. With this funding, States were able to develop outreach 
programs and educational materials for under-served rural, urban and 
diverse ethnic populations. It enabled States to develop respite 
resources and other supportive services. The program also funded the 
development of a wealth of training materials for primary and long-term 
care providers of people with Alzheimer's.
    The current phase of the Alzheimer's Disease Demonstration Grants 
funded nine additional States. The focus is on integrating dementia 
care services into the mainstream home and community based care system.
    The four Maryland chapters of the Alzheimer's Association benefited 
from this critical funding in the first demonstration program from 1992 
to 2000 and it has truly made a difference for families coping with 
Alzheimer's disease. It enabled the Alzheimer's Association to reach 
thousands of families who were not using services, because they did not 
know they were available or because they did not know how to access 
them.
    The Western Maryland, Eastern Shore and Southern Maryland sites 
targeted families in rural areas. These sites collaborated with other 
community agencies and developed care coordination programs to help 
effectively connect families to services. Here in Baltimore City, we 
focused on outreach to African American families. This funding helped 
our chapter to establish the three support groups targeted to African 
American caregivers, and it has resulted in increased participation of 
African American families in all of our services.
    The Maryland Alzheimer's Demonstration Grant has had a significant 
impact on the availability and accessibility of supportive services for 
caregiving families. It enabled the chapters to offer respite care 
subsidies, to give family caregivers time off to rest. It increased the 
number of caregiver education programs, to inform caregivers about the 
disease and about how to access community resources. It provided for 
training of assisted living, nursing facility, home health agencies and 
adult daycare staff, to enhance the quality of care for people with 
Alzheimer's. It helped the chapters to train physicians and health care 
professionals in community clinics, to encourage early diagnosis and 
intervention with treatments and services. Finally, it promoted 
collaboration among the Alzheimer's Association chapters and public 
agencies to better coordinate care and services throughout Maryland.
    The Alzheimer's Association is participating in the current 
Alzheimer's Demonstration Grant Program through the Maryland State 
Department of Aging. This program has sites in two areas of the State 
with limited caregiver services, the Eastern Shore and Southern 
Maryland. The funding has established a consumer-directed respite 
program for family caregivers. It also is helping to strengthen the 
skills of existing and future health care workers through dementia 
training. It is encouraging the development of new services by offering 
training to entrepreneurs on how to start and manage a respite services 
business.
    Senator Mikulski, speaking on behalf of the Alzheimer's 
Association, and the 85,000 Marylanders with Alzheimer's and their 
families, I applaud your efforts to expand these critical programs 
through the Alzheimer's Disease Research and Caregiver Act. This bill 
will help continue to ensure that no one faces this illness alone, by 
providing essential, accessible services and hope for the future.
                    Prepared Statement of Sue Vaeth
    Ms. Chairman and Members of the Committee:
    I am pleased to submit written testimony on behalf of the Maryland 
Department of Aging (MDoA) regarding Maryland's Alzheimer's 
Demonstration Project.
    MDoA's mission, in partnership with the local Area Agencies on 
Aging, is to provide leadership and advocacy for older Marylanders and 
their families through information, education, programs, and services 
that promote and enhance choice, independence and dignity. The 
Alzheimer's Demonstration Grant Project allows us to develop new 
methods of providing services that address our mission.
    Given the recent increases in State and Federal funding for 
services in the support of family caregivers, the State needed to build 
on its current service delivery systems to facilitate the access of 
families caring for individuals with dementia to the services that were 
developed with these funds. Maryland began this process by taking 
advantage of the National Alzheimer's Demonstration Project funding to 
im

[[Page 35]]

prove the responsiveness of the existing home and community-based care 
system for persons with dementia and their families. Maryland's project 
focuses on developing an innovative rural model that addresses the 
critical lack of dementia-competent service providers, as well as 
providing respite to families in the ways families determine to be most 
helpful. As part of this project, MDoA is working with private partners 
to move interdepartmental and community-based efforts forward to create 
a more efficient and accessible system. The Alzheimer's Association and 
local micro-enterprise business developers play a significant role in 
this project.
Background
    The State of Maryland received Alzheimer's Disease Demonstration 
Grants to States funding from 1992 to 2000. During this time the 
Alzheimer's Association chapters, in partnership with the Maryland 
Department of Human Resources, led successful outreach efforts to 
inform rural areas and the City of Baltimore about resources for 
individuals with Alzheimer's disease. The funding helped develop and 
grow a new Alzheimer's Association chapter on the Eastern Shore, 
established a branch office in Southern Maryland, and assisted the 
Western Maryland Chapter to establish a branch office in Hagerstown. 
The project dramatically improved the capacity of the Central Maryland 
Chapter to serve African-American families and improve care networks in 
Baltimore City. The demonstration project made significant progress in 
developing support groups among minority and rural populations, as well 
as training family caregivers. In recent years, the project trained 
hundreds of health care providers and physicians about Alzheimer's 
disease.
    This project was noteworthy in its ability to involve communities 
in addressing their own particular needs. A strong infrastructure now 
exists in rural, underserved areas as a result of this demonstration 
grant.
    Since the inception of this project, significant changes have 
occurred. While Alzheimer's disease is a now a household word, families 
in rural areas are still having difficulty accessing services. Those 
with and without the ability to pay cannot find individuals who will 
provide the care needed. The booming economy of the late l990s and 
early 2000 created a demand for employees and low unemployment. 
Individuals willing to accept a demanding, skilled position for low 
wage, inconsistent hours and few benefits became increasingly more 
difficult to find, even in rural areas with higher than average 
unemployment. Developing new services for people with dementia in rural 
areas is challenging. The lack of large population centers, the absence 
of a private-pay market, the small or non-existent pool of trained 
employees, and the inadequate reimbursement from public sources, 
creates an unresponsive environment for individuals or organizations 
seeking to serve the growing population of individuals with dementia.
    The new Alzheimer's Demonstration Project provides the technical 
assistance necessary for developing these potential providers' capacity 
to meet the demands of the growing aging population.
The Demonstration Project
    The Maryland Alzheimer's Demonstration Project (ADP) has two 
objectives: (1) the project will expand the number of rural providers 
of dementia-competent care through developing micro-enterprises, or 
small businesses owned by low-income entrepreneurs; and (2) the project 
will implement a consumer-directed respite care model to improve the 
responsiveness, efficiency and quality of care for people with dementia 
and their families.
    The project is being piloted by three Area Agencies on Aging (AAA), 
St. Mary's, Charles, and MAC, Inc., which serves the four lower Eastern 
Shore counties. All sites focus on the low-income, rural population.
    At least sixty individuals and families will receive respite care 
in a way that provides the most relief to them. Families are given 
guidance and counseling in developing a plan for services. They 
determine who will provide the care, and when and how often it will be 
used. Families may identify neighbors or other family members to 
provide respite care, or they may choose a provider agency or an adult 
daycare center.
    The individuals with dementia were on a waiting list for Maryland's 
Senior Care Program services. The Senior Care Program, financed by 
State funds and administered by MDoA, fills gaps in services for low-
income, older people who have significant functional impairments. The 
Senior Care Program creates a package of services that assists 
individuals to remain in their homes rather than enter a long-term care 
facility. The waiting list exists because of limited funding and the 
lack of service providers. Respite funds from the Alzheimer's 
Demonstration Grant Program have immediately enabled individuals who 
qualify to begin to receive services. Most im

[[Page 36]]

portant, family caregivers are in charge of what kind of respite 
services will be provided and who provides the services.
    The consumer-directed model will be implemented in tandem with 
activities to address the lack of qualified service providers in rural 
areas. The Maryland ADP is tackling this issue using a strategically 
executed effort to assist individuals to become independent 
contractors, to develop micro-enterprises or small businesses owned and 
operated by low-income entrepreneurs, and to enhance the dementia-care 
expertise of existing providers who may not currently serve individuals 
with dementia.
    As a result of Maryland's efforts, we expect that at least twenty-
five micro-enterprises will develop business plans and begin service to 
individuals with Alzheimer's Disease and their families. The micro-
enterprise partners will train individuals who express an interest in 
starting their own caregiving businesses. The new entrepreneurs will 
attend classes that include tax and regulations issues, and other 
relevant business practices. In addition, new providers, other existing 
providers, and family members may receive specific training on working 
with people who have dementia.
    The Maryland Department of Aging will develop a manual on consumer 
directed services and the Alzheimer's Association will develop a manual 
for how to create micro-enterprises. The manuals will be published and 
made available so this project can be duplicated in other Maryland 
counties and nationwide.
    The Maryland ADP will result in an improvement in the families' 
satisfaction with the services they receive, improved access to respite 
and other services that assist families to care for individuals with 
dementia, and improved service delivery systems.
Accomplishments
    In the first nine months of the project, the participating Area 
Agencies on Aging have provided case management and/or respite services 
to 67 families. The Alzheimer's Association has entered into 
partnerships with local micro-enterprise businesses to develop a 
curriculum and training for potential providers. The first of these 
training sessions is scheduled for April 2002. Thirty-two people have 
signed up to take these business classes. The Alzheimer's Association 
has also held several training sessions about dementia for family 
caregivers and existing care providers. Additional training sessions 
will be offered throughout the grant period.
    The following story illustrates how the demonstration project, with 
just a little bit of money and some case management guidance has made a 
difference for one family.
    Mary, 29-year-old woman, has been caring for her mother for 6 
years. Mary's mother is diagnosed with Alzheimer's disease, and needs 
24-hour care due to constant pacing and wandering. Mary's mother cannot 
attend the adult daycare center because of the wandering. Mary assists 
her mother with feeding, bathing and other personal care. She does not 
want to place her mother in a nursing home.
    Mary's husband works during the day and takes care of their two 
children, ages 6 years and 6 months, and his mother-in-law in the 
evenings. Mary works part time in the evenings at a fast food 
restaurant in order to help meet financial obligations.
    When the case manager first visited her, Mary was tearful, 
exhausted and afraid of losing control. With the guidance of the case 
manager over several visits, Mary was able to find a friend who could 
help her care for her mother. The grant funds pay for this expense. If 
not for the grant, Mary would not be able to get respite assistance. If 
she desires, Mary's friend will be able to take advantage of the 
dementia training that is offered by the Alzheimer's Association.
             Prepared Statement of Judith A. Salerno, M.D.
    Senator Mikulski:
    Thank you for inviting me to appear before you today to discuss 
Alzheimer's disease (AD), an issue of interest and concern to us all. I 
am Dr. Judith Salerno, Deputy Director of the National Institute on 
Aging (NIA), the lead Federal agency for Alzheimer's disease research. 
As a geriatrician who has spent much of my career working with AD 
patients and their families, I am delighted to be here this morning to 
tell you about the exciting progress we are making toward 
understanding, treating, and preventing AD.
    As you know, AD is a major public health issue for the United 
States, and it has a devastating impact on individuals, families, the 
health care system, and society as a whole. An estimated 4 million 
Americans are currently battling the disease, with annual costs 
estimated to exceed $100 billion. Moreover, the rapid aging of the

[[Page 37]]

American population threatens to increase this burden several-fold in 
the coming decades.
    However, despite the grim statistics, we have made, and are making, 
tremendous progress.
    When I first began working with AD patients as a clinical 
researcher in NIA's Intramural Program in 1988, preventing or curing AD 
was considered, at best, a distant possibility.
    Our understanding of AD's underlying biology was limited, and for 
this reason it was difficult even to predict what might be effective as 
a treatment or preventive.
    Today, the picture is considerably brighter. Through laboratory and 
population-based scientific studies, we have identified a number of 
risk factors for AD, including both genetic and possible lifestyle 
factors. Research supported by the NIA and the National Institute of 
Mental Health (NIMH) has identified several genes that can cause AD, 
thereby helping us identify pathways affecting its development or 
progression, which will lead to better molecular predictors of the 
disease even before it is clinically apparent.
    The development and refinement of powerful imaging techniques that 
target anatomical, molecular, and functional processes in the brain 
will give us an improved ability to diagnose AD early, while the 
patient can still take an active role in decisionmaking.
    These techniques, along with better neuropsychological tests, are 
also enabling us to identify people who are at very high risk of one 
day developing the disease and to determine just how the disease starts 
in brain. This knowledge, in turn, may allow early intervention in 
persons long before the disease affects their level of functioning.
    Most importantly, we are making significant advances toward 
effectively treating, or even preventing, AD. NIA is currently 
supporting 18 AD clinical trials, seven of which are large-scale 
prevention trials. These trials are testing agents such as estrogen, 
anti-inflammatory drugs, and anti-oxidants for their effects on slowing 
progress of the disease, delaying AD's onset, or preventing it 
altogether. We eagerly await the results of these trials.
    As we search for effective preventive interventions and treatments 
for AD, it is becoming clear that, rather than seeking only a ``magic 
bullet'' that will, by itself, prevent or cure the disease, we may be 
able to identify a number of potential interventions that can be used 
to reduce risk. Several recent studies have highlighted this.
    For example, a recent study in the New England Journal of Medicine 
\1\ indicates that elevated blood levels of the amino acid 
homocysteine, already considered a risk factor for cardiovascular 
disease, are associated with an increased risk of developing AD. The 
relationship between AD and homocysteine is of particular interest 
because blood levels of homocysteine can be reduced, for example, by 
increasing intake of folic acid (or folate) and vitamins B6 and B12. 
And, in fact, in a separate study in the Journal of Neuroscience. \2\ 
NIA researchers show that folic acid may protect mice against some of 
the symptoms of AD. NIA has ongoing clinical trials of these substances 
to test whether supplementation can slow the rate of decline in 
cognitively normal men and women as well as in women at increased risk 
for developing dementia, and a trial on people diagnosed with AD is due 
to start in 2003. Other studies have indicated that the use of statins, 
the most common type of cholesterol-lowering drugs, may lower the risk 
of developing AD. A study of statins to slow the rate of disease 
progression in AD patients is planned for fall 2002.
---------------------------------------------------------------------------
    \1\ S. Sesdradri, A. Beiser, J. Selhub, et al., ``Plasma 
Homocysteine As A Risk Factor For Dementia and Alzheimer's Disease,'' 
N. Eng. J. Med., 346:7,pp.476-483.
    \2\ Kruman, T.S. Kumaravel, A. Lohani, W. Pedersen, R.G. Cutler, Y. 
Kruman, N. Haughey, J. Lee, M. Evans, and M.P. Mattson, ``Folic Acid 
Deficiency and Homocysteine Impair DNA Repair in Hippocampal Neurons 
and Sensitize Them To Amyloid Toxicity in Experimental Models of 
Alzheimer's Disease,'' Journal of Neuroscience, 22:5,pp.1752-1762.
---------------------------------------------------------------------------
    Another promising area of study is the role of mentally stimulating 
activities throughout life as a factor capable of maintaining cognitive 
health or even reducing the risk of cognitive decline or AD. Through 
its Advanced Cognitive Training for Independent and Vital Elderly 
(ACTIVE) study, NIA is currently exploring whether three specific 
interventions (on memory, reasoning, and speed of processing) can 
maintain or improve functioning in unimpaired, community-dwelling older 
adults. In addition, NIA-supported researchers recently found that more 
frequent participation in activities such as reading, doing crossword 
puzzles, or playing card games is associated with a reduced risk of 
later developing AD. \3\
---------------------------------------------------------------------------
    \3\ Wilson RS, Mendes de Leon CF, Barnes LL et al., ``Participation 
in Cognitively Stimulating Activities and Risk of Incident Alzheimer 
Disease,'' JAMA 287: 742-748.

---------------------------------------------------------------------------

[[Page 38]]

    In addition, scientists funded by NIA and NIMH are developing and 
refining powerful imaging techniques that hold promise of earlier and 
more accurate diagnosis of AD, as well as improved identification of 
people who are at risk of developing the disease. For example, recent 
studies suggest that positron emission tomography (PET) scanning of 
metabolic changes in the brain and magnetic resonance imaging (MRI) 
scanning of structural brain changes may be useful tools for predicting 
future decline associated with AD and other neurodegenerative diseases. 
Researchers have also developed a new method of functional MRI (fMRI), 
a technique for visualizing activity of brain structures, that is both 
easier on the person being tested and capable of imaging smaller 
structures in the brain than has been possible in the past.
    These methodologies may also be useful for evaluating the efficacy 
of drugs in stemming the progression of AD or preventing its onset 
altogether. However, these and other emerging imaging techniques, while 
promising, require further testing and analysis before they can be 
routinely adopted in the clinical setting.
    Another very important area of research involves easing the burden 
on caregivers of AD patients. In a sense, the AD ``patient'' is not 
only the person with the disease, but the entire family unit is. Most 
Americans with AD are cared for outside the institutional setting by an 
adult child or in-law, a spouse, another relative, or a friend. The 
financial costs of this care can be devastating to families; by one 
estimate, the average lifetime cost per person for patients with AD is 
$174,000. In addition to these financial burdens, caregivers frequently 
experience significant emotional stress and physical strain, yet they 
often do not receive adequate support.
    NIA is investing in new approaches to assist these often forgotten 
Americans. A first priority is to assess the magnitude of the problem. 
For example, the ongoing Aging, Demographic, and Memory Study (ADAMS) 
has been designed to assess dementia and AD among Americans, the burden 
on caregivers, the economic cost of dementia to families and to 
society, and the burden of dementia over the course of the illness.
    NIA is also supporting a study of a combined behavioral and drug 
intervention on patients with mild AD. In this study, caregivers will 
be key participants in the behavioral intervention, and the researchers 
hypothesize that this participation will reduce caregivers' 
psychological stress. In addition, NIA is supporting a large, multi-
site clinical trial, REACH (Resources for Enhancing Alzheimer's 
Caregiver Health), to examine the effectiveness of various 
interventions to strengthen family members' capacity to care for 
individuals with AD. Thus far, the study has recruited over 1200 
caregiver/care recipient pairs at six different sites across the 
country to participate in 12 different interventions. REACH is designed 
to show us what works to support caregivers and at what cost; we 
anticipate that the first findings from this trial may be available 
within the next several years. The NIMH is supporting a major project 
called the Clinical Anti-psychotic Trial of Intervention Effectiveness 
for Alzheimer's Disease (CATIE-AD) designed to help identify effective 
treatments for behavioral problems in AD, to help reduce the burden of 
care for both providers and families.
    The process of translating basic science findings into clinical 
interventions is a challenging but critical component of AD research. 
One promising finding of recent basic research efforts was the ability 
of an immunization strategy to prevent or reverse formation of amyloid 
plaques in mouse models of AD. The initial clinical trial of this AD 
vaccine approach, conducted by the Irish pharmaceutical company Elan 
Corporation, plc and not an NIH-funded trial, was halted earlier this 
year when a number of participants on the experimental treatment were 
found to have brain inflammation. Despite the unfortunate outcome of 
this trial, the science on which the study was based will provide a 
base on which to build better and safer strategies for arresting or 
reversing the brain lesions of AD. In collaboration with the National 
Institute of Neurological Disorders and Stroke (NEDS), NIA has already 
issued a Request for Applications (RFAs) and funded a number of studies 
to better understand the science underlying the vaccine approach.
    The RFA with NINDS is one of many collaborations in which the NIA 
participates as part of its program of AD research. NIA frequently co-
sponsors RFAs and Program Announcements (PAs) with other institutes, 
and leads an inter-institute AD working group. With NINDS and NIMH, NIA 
co-sponsors the Cognitive and Emotional Health Project (Healthy Brain 
Project), the goals of which are to assess the current state of 
knowledge of predictors of cognitive and emotional health with age and 
to accelerate the pace of scientific advances in these fields. NIA also 
collaborates with other institutes, including NlNDS and the National 
Institute of Child Health and Human Development, to conduct preclinical 
toxicology tests on compounds that may be effective against AD, and, 
with the National Center for Complementary and Alternative Medicine, 
co-sponsors a large clinical trial of ginkgo biloba as an AD 
preventive.

[[Page 39]]

    Fifteen years ago, we did not know any of the genes that could 
cause AD, and we had no idea of the biological pathways that were 
involved in the development of brain pathology. Now, we know the three 
major genes for early onset disease and one of the major risk factor 
genes for late-onset disease, and we have extensive knowledge of 
pathways leading to the development of AD's characteristic amyloid 
plaques in the brain. Ten years ago, we could not model the disease in 
animals. Today, transgenic mice are an invaluable resource for modeling 
amyloid plaque development in the brain and in testing possible 
therapies. Five years ago, we did not have any prevention trials funded 
and had no ways of identifying persons at high risk for the disease. 
Now, we have seven ongoing prevention trials, and scientists are 
identifying persons at high risk for developing AD by imaging, 
neuropsychological tests, and structured clinician interviews. And as 
recently as one year ago, we did not understand anything about how 
plaques and tangles relate to each other. Now, through the creation of 
the first double transgenic mouse to produce both plaques and tangles, 
we know that plaques in the brain can influence the development of 
tangles in brain regions susceptible in AD.
    It is difficult to predict the pace of science or to know with 
certainty what the future will bring. However, the progress we have 
already made will help us speed the pace of discovery, unravel the 
mysteries of AD's pathology, and develop safe, effective preventions 
and treatments, to the benefit of older Americans.
    Thank you, Senator Mikulski, for giving me this opportunity to 
share with you our progress on Alzheimer's disease. I would be happy to 
answer any questions you may have.
          Prepared Statement of Constantine G. Lyketsos, M.D.
    Good morning. Let me begin by thanking you Senator Mikulski for 
holding this very important hearing and for inviting me to testify this 
morning. This is just one more example of your constant and invaluable 
leadership in the fight to conquer Alzheimer's disease. I am delighted 
to be here with my friends from the Alzheimer's Association and want to 
acknowledge that organization's ongoing staunch advocacy here in 
Baltimore, in Maryland, and across the country, on behalf of people 
with Alzheimer's disease and their families. It is an honor for me to 
serve as chair of the Medical/Scientific Advisory Committee to the 
Central Maryland Chapter of the Association.
    I also want to acknowledge Dr. Richard Hodes, Director of the 
National Institute on Aging (NIA) and his Deputy Director, Dr. Judy 
Salerno who is also with us today. They are leading a rapidly 
escalating effort, not just at NIA but also across institutes 
throughout NIH, to find the answers to Alzheimer's disease. They have 
attracted the best scientists to this important enterprise--now they 
need the money from Congress to take advantage of the scientific 
opportunities that have been created.
    I speak to you today as a scientist and medical school professor at 
Johns Hopkins, as a physician who has cared for thousands of patients 
with Alzheimer's disease and their families, but also as the spouse of 
a woman whose grandmother suffered greatly before dying from this 
horrible illness. Alzheimer's has touched me personally, as it has so 
many here in this room today.
    Most of us are likely to live at least until age 65, and many of us 
will live to age 85 or older. In fact, when I ask audiences to whom I 
speak how many expect to live to be 85 years, almost everyone raises 
their hand. Those of us living to 65 have 1-in-10 chance, and those of 
us living to 85 have as much as a 1-in-3 chance of developing 
Alzheimer's disease or a related condition. Therefore, the specter of 
Alzheimer's disease is a very personal one. It will affect us all 
directly or indirectly in the years to come.
    Research is an essential part of the battle to conquer Alzheimer's 
disease. The ultimate goal must be to find treatments that will cure, 
prevent, or delay this illness. At the same time, we must focus our 
energies on research designed to improve the lives of the 4 million 
victims currently alive in the United States, and the countless others 
worldwide, for whom a prevention or cure will come too late. And, we 
must research ways to improve the lives of the caregivers, who are just 
as affected by the disease. It is critical that we as a Nation dedicate 
adequate resources to this effort.
    That is why I so strongly endorse S. 2059, the Alzheimer's Disease 
Research, Prevention and Care Act of 2002, which you and Senator 
Kennedy have introduced to assure adequate resources for the essential 
research that must be done in the immediate years ahead. And by 
reauthorizing and expanding the Alzheimer's grant programs to the 
State, you will help assure that what we learn about Alzheimer's 
disease is translated to better access, care and treatment for people 
with the disease and their caregivers.

[[Page 40]]

    Your bill provides the essential stimulus to help the goal set by 
the Alzheimer's Association and endorsed by your colleagues on the 
Senate Appropriations Committee, to increase Federal funding for 
Alzheimer's research to $1 billion per year.
    Good research is costly, but the potential return on investment is 
huge. For a Congress concerned about controlling health care spending 
and guaranteeing the future of Medicare, finding a way to stop 
Alzheimer's disease must be a very high priority.
    We at Johns Hopkins are proud to be at the forefront of both 
research and care of Alzheimer's and related disorders. Our memory 
disorders clinical program, one of the first ever established in the 
United States, spanning the several Johns Hopkins medical institutions 
and our affiliated long-term care facility, Copper Ridge, provides 
diagnostic evaluations and ongoing care ``from diagnosis to the end of 
life'' for thousands of patients with Alzheimer's every year.
    We now know a great deal about evidence-based, systematic care for 
people with Alzheimer's disease, which can make a substantial 
difference in the lives of our patients and their families. Current 
treatments, which include a combination of medications, counseling, and 
a variety of other interventions have been shown to alleviate symptoms, 
to delay institutionalization, and to delay the course of this 
progressive illness. While the cure is not yet on hand, what we have 
today can be of great benefit when properly applied. While it is beyond 
the topic of this particular hearing, I would emphasize the urgency of 
incorporating this knowledge into health and long term care policy. 
That includes adding a prescription drug benefit and chronic care 
coverage to Medicare.
           alzheimer's research opportunities and priorities
    We are here today to discuss the research needs for the future. 
These can be summarized in a few broad strokes.
    First, we need to better understand the biology of Alzheimer's 
disease. This involves laboratory work to understand the complex 
mechanisms involved in the brain degeneration, the hallmark of the 
condition. My colleagues at the NIA-funded Johns Hopkins Alzheimer's 
Disease Research Center are working hard every day in this effort.
    Second, we need to better characterize risk and preventive factors 
for Alzheimer's disease through epidemiologic research. Research at 
Johns Hopkins has already led to the identification of estrogen and 
NSAIDs (non-steroidal anti-inflammatories) as possible preventive 
factors, and to the implementation of prevention studies using both of 
these treatments.
    Much more needs to be known about the risk and preventive factors 
for dementia so as to develop effective preventions or treatments. 
Currently under investigation are the role of genes, nutrients, 
medications (prescription and over the counter), and other biological 
factors (e.g., homocysteine) in the development of AD. Recent research 
out of Hopkins indicates that the incidence of Alzheimer's peaks and 
then declines in late life. This research also suggests that a large 
proportion of the population may not be susceptible to the development 
of Alzheimer's. The reason for this non-susceptibility likely includes 
some combination of protective factors involving both genes and 
environment. Identification of protective genes and their gene products 
would be a major breakthrough.
    One area of enormous potential, where basic biological, 
epidemiological, and clinical research overlap, is the growing evidence 
of the connection between vascular disease and Alzheimer's. We already 
know about risk factors and effective prevention of vascular disease. 
If we can better understand these connections, we may be on the path to 
prevention of Alzheimer's as well. This is a particularly important 
field of research for people of color, particularly African-Americans 
and Hispanics, who are at higher risk of vascular disease.
    Third, we need to improve the accuracy and ease of the diagnosis of 
Alzheimer's disease. In academic medical centers such as Johns Hopkins, 
we can achieve diagnostic accuracy of over 90 percent in many cases; 
but that level of diagnostic accuracy is not realized in most clinical 
settings. We know now that Alzheimer's disease has a long pre-clinical 
phase, where the disease is damaging the brain, but when there are no 
symptoms. At present we do not have the capability of diagnosing the 
disease in these very early stages of its development. Yet, accurate 
diagnosis is critical to effective treatment. In addition, the earlier 
the diagnosis, the greater the effectiveness of treatments. Also, 
diagnostic tests that are accurate may provide clues to the biology of 
the illness. A wide range of diagnostic tests, including cutting edge 
imaging techniques of the living brain, must be evaluated for this 
purpose.
    Fourth, we need to improve our understanding of the full range of 
clinical manifestations of the disease. Recent research from our group 
has found that as many

[[Page 41]]

as 90 percent of patients develop non-cognitive symptoms such as 
depression, agitation, delusions, hallucinations, and distressing 
behaviors. Most of these are a direct consequence of the brain damage 
that the disease brings about. These are very troubling symptoms which 
dramatically worsen the lives of patients, burden caregivers, and can 
rapidly lead to early institutionalization. They also create some of 
the most difficult challenges for residential facilities caring for 
persons with dementia. Effective management of the symptoms can have a 
wide range of benefits, for the patient, the family, and the formal 
care system.
    Fifth, we must substantially and immediately increase research into 
the treatments of Alzheimer's disease. The most exciting possibility 
comes from recent knowledge of the pre-clinical phase of Alzheimer's 
disease. It turns out that the disease is damaging the brain for many 
years before the onset of any symptoms. This offers an opportunity to 
intervene and stop or slow it before symptoms occur. That is the key to 
preventing Alzheimer's. One estimate indicates that if the disease 
could be delayed by 5 years, the number of people suffering from the 
disease would be reduced by half. To this end the National Institute of 
Aging has initiated prevention studies to find out whether certain 
medications can prevent the onset of Alzheimer's symptoms and other 
Institutes are now joining NIA in that effort.
                   clinical studies at johns hopkins
     At Johns Hopkins we are proud to have a leadership role in these 
clinical studies. By way of example, I mention today the Alzheimer's 
Disease Anti-inflammatory Prevention Trial or ADAPT in which I have a 
leadership role. ADAPT is designed to find out whether healthy people 
70 and older without memory symptoms, who have a family history of 
Alzheimer's, are less likely to develop the disease if treated with 
non-steroidal anti-inflammatory medications. This study has already 
enrolled 600 people at six sites nationwide, one of which covers the 
Baltimore-Washington area. We eventually plan to enroll a total of 
2,400 participants over the next year-and-a-half. I would like to take 
a moment to acknowledge the presence in the room my staff of the ADAPT-
Baltimore team who are working extremely hard in this critical study. 
This, along with other studies investigating other potential treatments 
or preventions such as estrogen, and ginkgo, are in the field 
recruiting participants.
    These sorts of studies are very expensive, each costing anywhere 
between $15 and $25 million, but they are the only way we will find the 
safe and effective way to stop Alzheimer's. Each study takes several 
years to complete and involves scores of clinicians as well as 
thousands of participants. The most promising studies involve healthy 
seniors, or people with mild cognitive impairment, who must be enrolled 
in sufficient numbers and over long enough periods of time for the 
symptoms of Alzheimer's disease to emerge. These studies also require 
substantial investment in outreach efforts to recruit and retain enough 
study participants, including particularly participants from the 
diverse ethnic and cultural backgrounds affected by Alzheimer's 
disease.
    The success of these studies depends not just on adequate funding, 
but also on educating our seniors about the availability of these 
studies and encouraging them to consider participation in them. That is 
another reason, Senator Mikulski, why this hearing and your very 
visible leadership is so important.
    In addition to these efforts to find ways to prevent Alzheimer's, 
laboratories at universities worldwide and several pharmaceutical 
companies are working aggressively to find effective medications for 
the treatment of Alzheimer's disease. Already we have several FDA-
approved treatments that have some benefits for disease symptoms. 
Redoubling laboratory efforts at drug discovery and bringing potential 
new medication treatments to clinical trials where we can assess their 
safety and efficacy should be a major undertaking over the next few 
years.
    Equally important to finding ways to treat the cognitive symptoms, 
we need to evaluate further treatments for the non-cognitive symptoms 
of the disease. That will yield great benefits for patients and 
families and for long term care providers. For example, in the 
Depression in Alzheimer's Disease Study funded by the National 
Institute of Mental Health, we have recently found that alleviation of 
depression may delay the functional decline of the disease.
    We must not limit ourselves to medication treatments since a 
variety of other interventions greatly benefit patients. With our 
affiliate, the Copper Ridge Institute, we are investigating the 
benefits of several non-medication treatments for Alzheimer's patients 
and their caregivers. Increased funding in this area, thus far 
primarily supported by the Alzheimer's Association, will also be 
necessary.
    Finally in the area of treatment, we need to be sure that we can 
deliver treatments where they are needed. I specifically want to 
mention the long-term care environment. Currently, about one-quarter of 
people with Alzheimer's disease, perhaps

[[Page 42]]

as many as one-third, live in residential care facilities. We have 
known for many years that a very large portion of the nursing home 
population has Alzheimer's or another dementia. We are only now finding 
this out about assisted living. In our Maryland Assisted Living Study 
(funded by the National Institute of Mental Health), our initial 
findings indicate that as many as two-thirds of residents suffer from 
memory disorders and that the detection and treatment of these 
disorders in that environment is sorely lacking. It is critical that we 
understand better the presence and course of Alzheimer's in assisted 
living and that we deliver the most effective available treatments to 
this population of patients as well.
    In summary, and with my deep appreciation for your inviting me to 
speak at this hearing, I would like to strongly emphasize that 
Alzheimer's is a disease that affects us all at a personal, an 
economic, and a societal level. Research is the key that will allow us 
as society to manage this scourge. Redoubling efforts of research in 
the laboratory, looking for risk factors and protective factors, 
improving diagnosis, understanding of the course of the disease, and 
developing a wide range of preventive and other treatments, with a 
special emphasis on drug discovery, and improving care must be our 
mission for the future.
               Prepared Statement of Henrique S. Nyankale
    Mr. Chairman, and Members of the Committee:
    My name is Henrique Shadrack Nyankale, a resident of the State of 
Maryland. I am a graduate student in Public Administration at George 
Mason University, and an Intern of the Metropolitan Washington Counsel 
of Governments in the Management and Operations Division in the Office 
of the Corporation Counsel, in Washington, DC. I am pleased to have the 
opportunity to present my testimony on the scourge of the Alzheimer's 
disease. I speak for my family and for the 4 million innocent Americans 
who found themselves victims of this disease. Remember our former 
President Ronald Reagan, who after serving this Nation so well, finds 
himself suffering from the scourge of this terrible disease called 
Alzheimer's?
    My interest in health policy advocacy began on the first week of 
June, 2002, when I was taking a Health Policy course from the 
Washington Health Policy Institute at the Law School of George Mason 
University in Arlington Campus, Virginia. In discussing the devastating 
effects of various diseases, the word Alzheimer's brought back bad 
memories to me, because my father-in-law died from this disease at the 
age of 65 in Johannesburg, South Africa. Before his death, our family 
experienced first-hand the physical, emotional and financial hardships 
of caring for him. We did not have access to any resources to help 
improve his condition, nor did we get any support to help us care for 
him at home. It was excruciating for us to watch his health deteriorate 
before our eyes each day. When I came to the U.S., I thought I came to 
heaven where no diseases penetrated. To my surprise, my health policy 
research has uncovered the shocking truth about the ugliness of the 
Alzheimer's disease. In my State--Maryland--alone, there were nearly 
80,000 Americans who had been diagnosed with Alzheimer's disease in the 
year 2000. This number is expected to jump to approximately 130,000 
within the next 28 years, a 62.5 percent increase, according to the 
U.S. Census Bureau's PPL-47 Report.
    Mr. Chairman, nationwide, the statistics that show the growing 
trend in the numbers of people who are, and will be diagnosed with 
Alzheimer's disease in the next 28 years are: 1. Disheartening to the 
coward, 2. Challenging to the courageous, and 3. Meaningless to the 
unconcerned, who happily lays in the false lull of the Alzheimer's 
silent killing tactics. Anyone interested in disproving my fear of--and 
challenge from--this looming national catastrophe should refer to the 
State-by-State current and predicted figures and percentages of 
Americans with Alzheimer's from the U.S. Census Bureau's PPL-47 Report 
developed by Paul R. Campbell, or find it at www.census.gov (and look 
for PP-47). The above statement presents an opportunity to both the 
Senate and House of Representatives. It is a boat of opportunity that 
both Houses may choose to board and save the millions of Americans who 
are being held hostage by the Alzheimer's or leave the Nation at the 
mercy of this ominous, ravaging and unmanned health destroyer called 
Alzheimer's disease.
    The results of the 2001 studies by Harold Rubin 
(www.therubins.com), have shown that: (1) Alzheimer's disease is the 
most prevalent neurodegenerative disease, and is considered non-
reversible; (2) In 1999 alone, 44,536 Americans died of Alzheimer's 
disease, making this disease the 8th leading cause of death nationwide, 
as reported in the National Vital Statistics Reports (Vol. 49, No. 8). 
According to the Centers for Disease Control, although Alzheimer's had 
ranked 12th among the leading causes of death in 1998, the 1999 death 
toll (indicated above) from Alzheimer's jumped in ranking from 12th to 
the 8th position, surpassing the totals for other various major causes 
of death, including motor vehicle accidents and cancer.

[[Page 43]]

    The June 7, 2001 Report of the American Medical Association 
indicates that Alzheimer's disease will reach epidemic proportions 
within the next few decades. This report issued an ominous prediction 
that the incidence of Alzheimer's disease will more than triple within 
the next 30-40 years, as life expectancy continually increases and as 
the 76 million baby boomers in the U.S. begin reaching age 65 in the 
year 2011. By 2050, the number of Americans aged 65 and older will have 
doubled from the current 35 million to 70 million people.
    Currently, approximately 4 million Americans are suffering from 
Alzheimer's disease, with annual costs approaching more than $100 
billion. The Alzheimer's Association predicts that the current 4 
million Alzheimer's figure will exponentially increase to 14 million by 
the middle of this century, unless a cure or prevention is found.
    The Alzheimer's Association also reports that more than 7 of 10 
people with Alzheimer's live at home with almost 75 percent of the home 
care provided by family and friends, which causes a great deal of 
physical, emotional and financial hardship, not only to the victims, 
but also to their loved ones who must devote extensive time and effort 
to care for them. At the national level, the impact of Alzheimer's 
disease on American businesses is alarming. Business costs associated 
with this disease totaled $33 billion in 1998 and nearly doubled to $61 
million in 2002. Currently, businesses spend over $36 billion annually 
in lost productivity as employees are absent from work to provide care 
to their loved ones with Alzheimer's disease.
    Let us look back in history for the precursor to the current bill. 
In 1982, the Alzheimer's Association established a Pilot Research Grant 
Program. In the same year, U.S. Representative Bill Lowery introduced 
legislation asking Congress to declare National Alzheimer's Disease 
Week. Later that year, President Ronald Reagan signed legislation 
designating Thanksgiving week as the National Alzheimer's Disease 
Awareness Week.
    In response to the 1983 Alzheimer's Association's launching of its 
``National Program to Conquer Alzheimer's Disease'' presented before 
the Select Committee on Aging, Congress allocated $22 million for a 
government-wide effort to find the cause and cure for Alzheimer's 
disease. President Ronald Reagan approved the creation of a task force 
to oversee and coordinate scientific research on Alzheimer's disease. A 
year later, and for the first time, Congress declared the month of 
November the ``National Alzheimer's Disease Month.'' In 1984, in 
recognition of the need to find cure for Alzheimer's disease, Congress 
allocated $44 million to Alzheimer's research, and through the National 
Institute on Aging, authorized support of the first five Alzheimer's 
Disease Research Centers.
    In 1986, Research grants were established to fund independent 
Alzheimer's research projects. With the assistance of the Alzheimer's 
Association, the National Institute on Aging and the Warner-Lambert 
Pharmaceutical Company initiated a clinical trial to test the THA on 
Alzheimer's patients. Since then, progress has been made in finding 
drugs that can slow down or cure a few early symptoms of Alzheimer's. 
To highlight the devastating nature of Alzheimer's disease, the U.S. 
Office of Technology Assistance, published the first report on 
Alzheimer's disease entitled ``Losing a Million Minds: Confronting the 
Tragedy of Alzheimer's Disease and Other Dementias.'' But we still have 
a long way to go in hunt for cure of Alzheimer's disease. In 1994, 
former President Ronald Reagan announced that he has been diagnosed 
with Alzheimer's disease.
    Efforts towards establishing legislation on Alzheimer's picked up 
momentum when in 1999, a bipartisan Congressional task force on 
Alzheimer's disease was launched by Representatives Edward Markey (D-
MA) and Christopher Smith (R-NJ). The bill's momentum was generated by 
Senators Barbara Mikulski and Edward Kennedy. Senator Mikulski 
sponsored the bill and both she and Senator Kennedy introduced it to 
the Committee on Health, Education, Labor and Pensions on March 21, 
2002. Progress has been marked by the Committee's passing of the bill, 
S. 2059, Alzheimer's Disease Research, Prevention and Care Act 2002. 
The introduction of this bill in the Senate has sparked off similar 
action in the House of Representatives where on June 25, 2002, 
Representative Edward Markey (D-MA) introduced a similar bill--H.R. 
4606--to the House Committee on Energy and Commerce where it is 
awaiting the committee's consideration.
    Looking at the progress this bill has made in both Houses, I am 
encouraged. I am happy to hear that on Wednesday, June 26, 2002, the 
Committee on Health, Education, Labor and Pensions passed S. 2059. 
Advocates of this legislation are happy to hear that the bill has been 
placed on the Senate Legislative Calendar under the General Orders, 
Calendar No. 483, for consideration by the full Senate. My heartfelt 
gratitude goes to Senators Mikulski and Kennedy for sponsoring this 
bill. I also thank Senators Cochran (R-MS), Hutchinson (R-AR), Miller 
(D-GA), and

[[Page 44]]

Dodd (D-T) who mustered courage and co-sponsored this bill. I also 
thank all the other Senators who voted for it.
    The purpose of the bill S. 2059, Alzheimer's Disease Research, 
Prevention and Care Act of 2002, is to foster the development of 
innovative models of care for persons with Alzheimer's disease and 
their caregivers, particularly the underserved minority, rural and low-
income populations. It reauthorizes the Alzheimer's Disease 
Demonstration Grant Program to assist individual States and calls for 
establishing an Alzheimer's Disease Cooperative Study Group. It also 
boosts Alzheimer's Disease Prevention Initiative by authorizing $1.5 
billion for the National Institute on Aging. If it passes the full 
Senate and Congress makes it into law, it will have tremendous impact 
on healthcare delivery in our Nation. Its benefits will include 
increasing the federal government's commitment to research on 
preventing and finding a cure for Alzheimer's disease. The bill will 
provide the most comprehensive legislation to date, expanding critical 
programs and services, particularly to underserved communities.
    On the other hand, if this bill is not made into law, a number of 
grave consequences will result. First, as life expectancy continues to 
increase and the 76 million baby boomers in our Nation begin reaching 
age 65 by 2011, the number of Americans stricken with Alzheimer's 
disease will increase exponentially, as predicted by experts. As a 
result, the number of Alzheimer's victims requiring full-time care will 
also increase tremendously. Billions of dollars will have to be spent 
by millions of caregivers as they take care of their Alzheimer's-
stricken family members. Business operations will be affected, as 
increasing numbers of employees will be forced to provide home care to 
their loved ones who suffer from Alzheimer's disease, resulting in 
increased employee absenteeism and lost productivity. Insurance costs 
will be so high that many people will not be able to afford health and 
long-term care for this debilitating disease.
    I, therefore, urge you all to support the passage of the bill S. 
2059, the Alzheimer's Disease Research, Prevention and Care Act of 
2002. Please vote in favor of this bill and help those who are 
skeptical realize the importance of continued research and support to 
victims and families plagued with Alzheimer's disease. Research and 
statistics make frightening predictions about the impact of Alzheimer's 
disease on our society, beginning within the next 10 years and 
skyrocketing within the next 30-40 years.
    Since Alzheimer's disease attacks mostly the aging population, we 
should remember that as more Americans (including many of us here 
today) approach age 65 and beyond, the chances of being struck by 
Alzheimer's increases dramatically. Let us not ``age in fear.'' Please 
remember that we are now able to use the Hubble telescope to scan outer 
space and see some never-before-seen formations of new stars, galaxies, 
planets and supernovas. We, the Americans, are attempting to land 
spacecrafts on comets. We are now able to walk in space and conduct 
technical repairs in space. We do all of this in the hopes of improving 
our lives in the future. Because we are able to do these things, we can 
challenge ourselves, look into the future, and sense the bleak and 
devastating impact of this dreaded disease and find ways and means to 
conquer Alzheimer's disease. Let us use our knowledge of science and 
medicine and advanced technology as the tactical weapons we can deploy 
to defeat and conquer Alzheimer's disease, so that we may all ``age 
gracefully'' and not ``in fear.''
    Mr. Chairman, the future of the 4 million Americans with 
Alzheimer's disease is in the hands of all the Senators who are 
listening to this testimony or are reading it from whatever source. 
They are the ones who have the power to vote for the passage of this 
bill S. 2059 into an Alzheimer's legislation. Therefore, the longevity 
of, or short-lived life of the 14 million Americans predicted to have 
Alzheimer's disease by the year 2030, is also in the hands of the 
Senators and Representatives. Your vote will show whether you are for 
or against Alzheimer's victims living longer.
    Past efforts should give us an impetus to surge forward and find 
ways to detect, confine, control, and eliminate the Alzheimer's 
disease. Please vote for the passage of the bill S. 2059, will you?
    Thank you, Mr. Chairman.

    [Whereupon, at 11:47 a.m., the hearing was adjourned.]

                                    

      
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