[Senate Hearing 108-715]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 108-715

                      ALZHEIMER'S DISEASE RESEARCH

=======================================================================

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION

                               __________

                            SPECIAL HEARING

                     MARCH 23, 2004--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations


 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 senate



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                               __________
                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio                    TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas                MARY L. LANDRIEU, Louisiana
                    James W. Morhard, Staff Director
                 Lisa Sutherland, Deputy Staff Director
              Terrence E. Sauvain, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
JUDD GREGG, New Hampshire            ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho                   DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas          HARRY REID, Nevada
TED STEVENS, Alaska                  HERB KOHL, Wisconsin
MIKE DeWINE, Ohio                    PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama           MARY L. LANDRIEU, Louisiana
                                     ROBERT C. BYRD, West Virginia (Ex 
                                         officio)
                           Professional Staff
                            Bettilou Taylor
                              Jim Sourwine
                              Mark Laisch
                         Sudip Shrikant Parikh
                             Candice Rogers
                        Ellen Murray (Minority)
                         Erik Fatemi (Minority)
                      Adrienne Hallett (Minority)

                         Administrative Support
                             Carole Geagley


                            C O N T E N T S

                              ----------                              
                                                                   Page

Opening statement of Senator Mike DeWine.........................     1
    Prepared statement...........................................     2
Statement of Dr. Richard J. Hodes, Director, National Institute 
  on Aging, National Institutes of Health, Department of Health 
  and Human Services.............................................     3
    Prepared statement...........................................     6
Statement of Johnny Orr, husband of Alzheimer's patient, West Des 
  Moines, IA.....................................................    11
Summary statement of Romie Orr...................................    12
Prepared statement of Johnny Orr.................................    13
Statement of Dennis Kroucik, Alzheimer's patient, Elryia, OH.....    14
    Prepared statement...........................................    15
Statement of Shelley Fabares, national board member, Alzheimer's 
  Association, Studio City, CA...................................    16
    Prepared statement...........................................    18
Statement of Sheldon Goldberg, president and CEO, Alzheimer's 
  Association, Chicago, IL.......................................    19
    Prepared statement...........................................    21
Statement of Dr. David Snowden, professor in the Department of 
  Neurology and the Sanders-Brown Center on Aging at the 
  University of Kentucky, Lexington, KY..........................    23
    Prepared statement...........................................    25
Statement of Senator Tom Harkin..................................    27
Prepared statement of Senator Mary L. Landrieu...................    35
Prepared statement of Phyllis Campbell, president, Urban League 
  of Lancaster County, Pennsylvania..............................    36
Questions submitted by Senator Mary L. Landrieu..................    37

 
                      ALZHEIMER'S DISEASE RESEARCH

                              ----------                              


                        THURSDAY, MARCH 23, 2004

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:33 a.m., in room SD-G50, Dirksen 
Senate Office Building, Hon. Mike DeWine presiding.
    Present: Senators DeWine and Harkin.


               OPENING STATEMENT OF SENATOR MIKE DE WINE


    Senator DeWine. Good morning. This morning I would like to 
welcome the members of the Alzheimer's Association and to 
congratulate all of you on the tremendous progress that you 
have made in the prevention, diagnosis, and treatment of 
Alzheimer's disease. We are pleased to be part of your 16th 
Public Policy Forum and to kick-off your Capitol Hill Day with 
this hearing this morning.
    We are honored to have before the subcommittee a 
distinguished panel of scientists, advocates and patients to 
discuss Alzheimer's disease. Senator Arlen Specter wanted me to 
express his regret that he has a scheduling conflict and may be 
joining us a little later today. He wanted me to convey to you 
his appreciation for your tireless efforts, tireless efforts on 
behalf of Alzheimer's patients and certainly their families.
    In our Nation today there are approximately 4.5 million 
Americans with Alzheimer's disease. In addition to the 
unbelievable human cost, there is, of course, the economic 
cost, a cost of over $100 billion every year. For years 
scientists have been predicting that the number of individuals 
with the disease will steadily rise and now a recent study in 
dictates that the Alzheimer's epidemic will be even worse than 
previously thought. The study predicts the prevalence of 
Alzheimer's disease will increase 27 percent by the year 2020, 
70 percent by 2030 and nearly 300 percent by 2050, when as many 
as 16 million Americans could be stricken. If these predictions 
become a reality scientists agree the disease could destroy our 
health care system and bankrupt Medicare and Medicaid, not to 
mention what this will do to our families. In my home State of 
Ohio alone there are approximately 212,000 people with 
Alzheimer's disease today. Based on population growth, unless 
science finds a way to prevent or delay the onset of this 
disease that number will skyrocket to 308,000 by the year 2025.


                           PREPARED STATEMENT


    The Federal Government's involvement in Alzheimer's disease 
research began in 1976, when three of the Institutes at the 
National Institutes of Health invested a total of $3.8 million 
in research into finding the cause of the disease. Today, 19 
Institutes have Alzheimer's projects as part of their research 
agenda and it is projected that $698.9 million will be spent on 
the disease in fiscal year 2005. The National Institute on 
Aging funds a network of approximately 30 Alzheimer's disease 
research centers around the country, one of which is operated 
by Case Western Reserve University Hospitals of Cleveland. The 
$6.5 billion that the Federal Government has invested in 
Alzheimer's disease research over the past 29 years has 
resulted in tremendous progress. We have seen great 
improvements in diagnostic tools that can help providers 
diagnose the disease with more than 90 percent accuracy. Genes 
have been identified that may put people at increased risk for 
developing Alzheimer's disease and medications are now 
available that can help to alleviate the symptoms of disease. 
This subcommittee is proud of our investment in Alzheimer's 
research. These funds are not only important for our loved ones 
but are a critical investment in the future of America.
    [The statement follows:]

               Prepared Statement of Senator Mike DeWine

    The Subcommittee will come to order. This morning I would like to 
welcome the members of the Alzheimer's Association and congratulate you 
on the tremendous progress that you have made in the prevention, 
diagnosis, and treatment of Alzheimer's disease. I am pleased to be a 
part of your 16th public policy forum and to kick off your Capitol Hill 
Day with this hearing.
    We are honored to have before the Subcommittee a distinguished 
panel of scientists, advocates, and patients to discuss Alzheimer's 
disease. Senator Specter wanted me to express his regret that he has a 
scheduling conflict and may be joining us a little later. He wanted me 
to convey to you his appreciation for your tireless efforts on behalf 
of Alzheimer's patients and their families.
    In our Nation today, there are approximately 4.5 million Americans 
with Alzheimer's disease, costing the economy over $100 billion 
annually. For years, scientists have been predicting that the number of 
individuals with the disease will steadily rise. And now, a recent 
study indicates that an Alzheimer's epidemic will be even worse than 
previously thought. The study predicts the prevalence of Alzheimer's 
disease will increase 27 percent by 2020, 70 percent by 2030, and 
nearly 300 percent by 2050, when as many as 16 million Americans will 
be stricken. If these predictions become a reality, scientists agree 
that the disease could easily destroy our health care system and 
bankrupt Medicare and Medicaid.
    In my home state of Ohio, alone, there are approximately 212,000 
people with Alzheimer's disease. Based on population growth, unless 
science finds a way to prevent or delay the onset of this disease, that 
number will skyrocket to 308,000 by 2025!
    The federal government's involvement in Alzheimer's disease 
research began in 1976 when three of the Institutes at the National 
Institutes of Health invested a total of $3.8 million in research into 
finding the cause of the disease. Today, 19 Institutes have Alzheimer's 
projects as part of their research agenda, and it is projected that 
$698.9 million will be spent on the disease in fiscal year 2005. The 
National Institute on Aging funds a network of approximately 30 
Alzheimer's disease research centers around the country, one of which 
is operated by Case Western Reserve University/University Hospitals of 
Cleveland.
    The $6.5 billion that the federal government has invested in 
Alzheimer's disease research over the past 29 years has resulted in 
tremendous progress. We have seen great improvements in diagnostic 
tools that can help providers diagnose the disease with more than 90 
percent accuracy. Genes have been identified that may put people at 
increased risk for developing Alzheimer's disease. And, medications are 
now available that can help to alleviate the symptoms of disease.
    This Subcommittee is proud of our investment in Alzheimer's. These 
funds are not only important for our loved ones, but are a critical 
investment in the future of America.

STATEMENT OF DR. RICHARD J. HODES, DIRECTOR, NATIONAL 
            INSTITUTE ON AGING, NATIONAL INSTITUTES OF 
            HEALTH, DEPARTMENT OF HEALTH AND HUMAN 
            SERVICES
    Senator DeWine. This subcommittee is now pleased to hear 
from our first witness. Dr. Richard Hodes is the Director of 
the National Institute on Aging at the National Institutes of 
Health. Since 1993, Dr. Hodes has served as the Director of the 
National Institute on Aging. He has also held several other 
posts at the NIH, including clinical investigator at the 
National Cancer Institute, a program coordinator for the U.S.-
Japan Cooperative Cancer Research Program and Deputy Chief of 
the Cancer Institute's Immunology Branch. He is a graduate of 
Yale University and received his M.D. from Harvard Medical 
School.
    Doctor, thank you very much for joining us and you may 
proceed.
    Dr. Hodes. Senator DeWine, thank you for the opportunity to 
join this hearing on Alzheimer's disease, a topic of great 
interest and concern to us all. You have well summarized the 
burden that Alzheimer's provides and presents to individuals, 
to families, to the health care system and in fact to society 
as a whole. Fortunately, these stark numbers do not tell the 
whole story and in fact the progress in Alzheimer's research 
offers promise to develop effective methods of treatment, to 
delay, ultimately to prevent Alzheimer's disease.
    Research from the laboratory, from clinical studies, from 
epidemiologic studies have continued to point towards clues of 
the underlying risk factors for Alzheimer's disease. We know 
that age is an outstanding example of these risk factors such 
that by age 85 and older nearly half of the individuals at that 
age will be affected. Understanding who is at high risk, who is 
not and why, is a critical aspect of identifying the process 
and developing means to intervene to alter it. We understand at 
the level of genetics a number of genes which cause early-onset 
of familial Alzheimer's disease and we've begun to learn more 
about those genes which are involved in the more common late-
onset examples of Alzheimer's disease. A year ago we mentioned 
an Alzheimer's disease Genetics Initiative and I'm pleased to 
report this year that initiative is well underway. The National 
Institute on Aging, together with the very critical 
collaboration of the Alzheimer's Association and dedicated 
patients and their families have moved significantly towards 
the goal of accruing a larger number of individuals necessary 
to identify genes, understand risk factors and develop new 
targets for intervention.

                                DIABETES

    In an effort to understand modifiable risk factors for 
Alzheimer's disease, it has been determined that diabetes, a 
condition which affects some 17 million Americans, increases 
the risk of dementia. It appears, however, from a recent study 
that, among older women with diabetes, those who have had 
treatment to control glucose have a decreased risk of 
Alzheimer's disease and so NIA-supported investigators working 
with the National Heart, Lung and Blood Institute's Action to 
Control Cardiovascular Risk in Diabetes (ACCORD) study, are 
looking to determine whether aggressive treatment to control 
blood sugar will effectively prevent Alzheimer's disease in 
individuals with diabetes.

                              NEUROIMAGING

    Brain imaging has been a modality that's been critical in 
providing a window to the brain, understanding both structure 
and function, the changes which precede and accompany 
Alzheimer's disease. However, until recently we have been 
unable to actually image the lesion specific to Alzheimer's. In 
the past year there has been a report of a very important 
element of progress toward this end, illustrated in the first 
slide displayed on the screen here.




    This is the result of studies identifying a novel tracer 
called Pittsburgh Compound B that appears to bind specifically 
to and therefore can help imaging of the amyloid lesions in the 
brain. The ability to identify such lesions will allow for 
earlier diagnosis and if this application proves to be valid, 
in fact may allow us to monitor the course of interventions 
designed to treat and even prevent disease.
    We talked a year ago about a Neuroimaging Initiative and 
again I'm pleased to report that this Initiative is now well 
underway with applications received under peer review and if 
peer review is indeed positive with the ability to begin the 
study within the current year. This is a really novel and 
landmark collaboration; it involves NIH, the Food and Drug 
Administration, the Center for Medicare and Medicaid Services, 
private sector pharmaceutical industries and imaging industries 
as well as the very important collaboration of the Alzheimer's 
Association. Its goal is to identify imaging markers that will 
allow early diagnosis of the disease and perhaps even more 
importantly allow us to monitor the progress in response to 
interventions, allowing us to more effectively, more rapidly 
and more cost-effectively develop interventions to treat and 
prevent disease.
    The development of treatments for Alzheimer's disease is 
based on clues that come from laboratory as well as 
epidemiologic studies and among the examples of newer 
approaches towards treating the lesions of Alzheimer's disease 
is that illustrated in this next figure, which uses a very 
important mouse model of Alzheimer's disease.




    What's shown here in the middle panel, pointed to by the 
arrow, is an example of the lesions, which are actually amyloid 
plaques in this mouse model of Alzheimer's disease, distributed 
in an area that's very similar to those which are seen in human 
patients with the disease. And the panels to either side are 
the result of expressing in these mice an increased level of 
proteins, in one case insulin-degrading enzyme, the other 
neprilysin, two naturally occurring compounds, and an example 
of the in which natural defenses can be mobilized to decrease, 
reverse, even prevent the accumulation of amyloid lesions. This 
provides an example, a model for the way in which such 
laboratory findings can be translated ultimately into 
interventions for humans.
    Finally, at the same time that we work towards developing 
cures and prevention for Alzheimer's itself, we retain a focus 
on the important population of care givers who take care of 
those currently afflicted with Alzheimer's disease. And so a 
clinical trial called REACH, Resources for Enhancing 
Alzheimer's Care Giver Health, is targeted at helping the 
status of care givers who all too often themselves suffer 
emotionally, physically and economically and the outstanding 
work they do to care for those with Alzheimer's.

                           PREPARED STATEMENT

    It is not possible to be precise in predicting exactly 
which of these research directions will most quickly produce 
the final outcome we desire, treatment, delay and ultimately 
prevention, but the pace of research summarized in some 
examples here provides hope greater than ever before that we 
will, in fact, find these interventions in time to spare many 
from the affliction of Alzheimer's disease.
    I again thank you for the opportunity to be here and 
welcome any questions that you may have.
    [The statement follows:]

               Prepared Statement of Dr. Richard J. Hodes

    Senator Specter and Members of the Committee: 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. Richard 
Hodes, Director of the National Institute on Aging (NIA), the lead 
federal agency for Alzheimer's disease research. I am delighted to be 
here today to tell you about the progress we are making toward 
understanding, treating, and preventing AD.
    As you know, AD is a devastating condition with a profound impact 
on individuals, families, the health care system, and society as a 
whole. Approximately 4.5 million Americans are currently battling AD, 
with annual costs for the disease estimated to exceed $100 billion.\1\ 
Moreover, the rapid aging of the American population threatens to 
increase this burden significantly in the coming decades: Demographic 
studies suggest that if current trends hold, the annual number of 
incident cases of AD will begin to sharply increase around the year 
2030, when all the baby boomers (born between 1946 and 1964) will be 
over age 65. By the year 2050, the number of Americans with AD could 
rise to some 13.2 million, an almost three-fold increase.\2\
---------------------------------------------------------------------------
    \1\ Data from the Alzheimer's Association. See also Ernst, RL; Hay, 
JW. ``The U.S. Economic and Social Costs of Alzheimer's Disease 
Revisited.'' American Journal of Public Health 1994; 84(8): 1261-1264. 
This study cites figures based on 1991 data, which were updated in the 
journal's press release to 1994 figures.
    \2\ Hebert, LE; Scherr, PA; Bienias, JL; Bennett, DA; Evans, DA. 
``Alzheimer Disease in the U.S. Population: Prevalence Estimates Using 
the 2000 Census.'' Archives of Neurology August 2003; 60 (8): 1119-
1122.
---------------------------------------------------------------------------
    But these numbers, however stark, do not tell the whole story. 
Although AD remains a major public health issue for the United States, 
we have made, and are continuing to make, dramatic gains in our ability 
to understand and diagnose AD that offer us the hope of preventing and 
treating the disease, to reverse the current trends. As a part of our 
Government and Performance Results Act, NIH has developed a long-term, 
high-risk goal of identifying at least one clinical intervention that 
will delay the progression, delay the onset, or prevent Alzheimer's 
disease.

                              RISK FACTORS

    Many Americans wonder whether they or their loved ones are at risk 
of developing AD. Sadly, as they age, many of them will be. The risk of 
AD increases dramatically with age, with nearly half of all individuals 
over age 85 being diagnosed.\3\ Many older Americans struggle with mild 
cognitive impairment (MCI), a condition that is frequently a precursor 
to AD; in one recent population-based study of cognition in the 
elderly, 22 percent of participants over 75, and 29 percent of those 
over 85, were diagnosed with MCI.\4\ Determining who is at high risk of 
developing AD and who is not--and why--will enable us to identify 
potential targets for preventive intervention, as well as those 
individuals who might benefit most from such interventions.
---------------------------------------------------------------------------
    \3\ Data from the Alzheimer's Association. See also Evans, DA; 
Funkenstein, HH; Albert, MS; et al. ``Prevalence of Alzheimer's Disease 
in a Community Population of Older Persons: Higher than Previously 
Reported.'' JAMA 1989; 262(18): 2552-2556.
    \4\ Lopez O, Jagust WJ, DeKosky ST, Becker JT, et al. ``Prevalence 
and Classification of Mild Cognitive Impairment in the Cardiovascular 
Health Study Cognition Study.'' Arch Neuro 60: 1385-1389, 2003.
---------------------------------------------------------------------------
    Through laboratory, clinical and population-based research, we have 
identified a number of risk factors for AD, including both genetic and 
lifestyle factors. We already know of three major genes for early-onset 
disease and have identified a major risk factor gene, ApoE4, for the 
more common late-onset disease. Recent findings are enabling us to 
close in on several others, thought to be on chromosomes 9, 10, and 12.
    However, neuroscientists have become increasingly interested in a 
specific set of genes that may influence not whether, but when, a 
person might develop symptoms of neurodegenerative disease. Delaying 
the onset of AD symptoms by even five years could greatly reduce the 
numbers of people who will have the disease, as well as providing 
additional cognitively-healthy time to those who will eventually be 
diagnosed.
    Recently, NIH-supported investigators found a gene on chromosome 10 
that they believe influences the age of onset of both Alzheimer's 
disease and Parkinson's disease. Using a novel method to match the 
genes of people affected with these diseases with the age at which 
study participants started developing symptoms, the scientists found 
that one gene, GSTO1, was significantly associated with late onset of 
both Alzheimer's and Parkinson's. This important work gives us new 
clues to the role of genetics in the timing of late-life forms of these 
devastating neurodegenerative diseases.
    Last year this Committee heard about the NIA's AD Genetics 
Initiative, a program to accelerate the pace of AD genetics research by 
creating a large repository of DNA and cell lines from families with 
multiple AD cases. The goal of this initiative is to develop strategies 
for identifying the additional late-onset AD (LOAD) risk factor genes, 
associated environmental factors, and the interactions of genes and the 
environment. The NIA's AD Genetics Initiative will intensify sample 
collection and encourage data sharing by providing access to a national 
repository to qualified investigators.
    This year, we have launched several well-integrated components of 
the Genetics Initiative. Mechanisms to efficiently identify and share 
large numbers of samples for AD genetic analysis have been developed 
through the recently-enlarged National Cell Repository for AD (NCRAD), 
and eighteen of the NIA's Alzheimer's Disease Centers (ADCs) have 
received supplemental funding to recruit new family members for 
participation. Uniform standards for sample collection have also been 
developed.
    In order to publicize the initiative, the NIA Office of 
Communications and Public Liaison, together with its Alzheimer's 
Disease Education and Referral Center, Columbia University, and NCRAD, 
partnered with the Alzheimer's Association to conduct focus groups and 
develop materials to publicize the initiative and help recruiting 
efforts. These publicity materials, including a workbook, CD ROM, fact 
sheet, and brochure were distributed at a recent meeting of all 
Alzheimer's centers and have been sent to ADCs and Alzheimer's 
Association chapters to further recruitment efforts.
    As of Late January, over 200 families, of the approximately 1,000 
needed, have been evaluated and are now enrolled in the study, and over 
800 blood samples have been logged at NCRAD. Working groups have been 
established which are helping to determine the most useful phenotypic 
data to be included in the data bank along with the biological samples. 
A major goal is the long-term follow-up of individuals participating in 
the study.
    Type 2 diabetes, which, according to the American Diabetes 
Association, affects approximately 17 million Americans, is another 
potential risk factor for cognitive decline and AD. In a recent study, 
researchers found that compared to older non-diabetic women, older 
women with type 2 diabetes were about 30 percent more likely to score 
poorly on tests of cognitive function, and that the risk increased with 
the duration of their condition. However, the diabetic women in the 
study who took glucose-lowering pills had a risk similar to non-
diabetic women. Recognizing the potential link between type 2 diabetes 
and cognitive decline, NIA researchers are currently participating in 
an offshoot of the National Heart, Lung, and Blood Institute's Action 
to Control Cardiovascular Risk in Diabetics (ACCORD) study. ACCORD 
evaluates whether more intensive glucose, blood pressure and lipid 
management can reduce cardiovascular disease in people with diabetes; 
the aim of this sub-study, ACCORD-MIND, is to test whether the rate of 
cognitive decline and structural brain change in people with diabetes 
treated with standard care guidelines is different than in people with 
diabetes treated with intensive care guidelines. Recruitment for the 
ACCORD study began in January 2003, and we anticipate that 2,800 people 
will participate in ACCORD-MIND.

                                IMAGING

    Powerful imaging techniques, including positron emission tomography 
(PET) and magnetic resonance imaging (MRI), are opening a window into 
the brain, allowing us to visualize not only anatomical structures but 
also functional processes and activities at the molecular level. The 
refinement of these techniques continues to have a profound effect on 
all areas of AD research.
    For example, improvements in brain imaging, coupled with the 
development of more sensitive cognitive tests, are enabling us to 
diagnose AD in the research setting with greater precision than ever 
before, despite the fact that there remains no scientifically validated 
method to visualize AD's characteristic amyloid plaques and 
neurofibrillary tangles in a living human. However, even this may be 
changing. Researchers have recently developed the first radiotracers, 
including a molecule called Pittsburgh Compound-B, that facilitate 
visualization of amyloid deposition in living AD patients using PET 
scans. Although further research is needed, these molecules may 
eventually offer us a powerful and accurate diagnostic tool for the 
disease.
    Visualization of brain structures and activities may also enable us 
to identify people at risk of developing the disease even decades 
before the onset of symptoms. In a recent study, investigators used 
positron emission tomography (PET) to examine the brains of 
asymptomatic young adults (ages 20-39) who were carriers of the APOE-e4 
gene, a common susceptibility gene for late-onset AD. Middle-aged 
carriers of this gene are known to have abnormally low rates of 
metabolism in the same brain regions as patients with AD; in this 
study, the investigators found the same brain abnormalities in the 
younger carriers of the gene. The precise link between the APOE-e4 
gene, the altered metabolism, and AD remains unknown, and more research 
is needed on this provocative finding, but it may offer important clues 
to AD's etiology and perhaps even a target for future prevention 
efforts.
    Advances in imaging also have the potential to speed our basic 
understanding of the disease--for example, to determine which 
pathological features of AD (plaque and tangle development, cell death, 
loss of connections between neurons) best correlate with cognitive 
loss. Improved imaging techniques may further enable us to visualize 
the effects of therapeutic interventions more rapidly and accurately, 
with the potential for making AD clinical intervention trials smaller, 
faster and more affordable.
    Last year, we told this Committee about our plans for a 
Neuroimaging Initiative, a longitudinal, prospective, natural history 
study of normal aging, mild cognitive impairment, and early AD to 
evaluate neuroimaging techniques such as MRI and PET, as well as other 
biological markers. This year, I am pleased to tell you that work on 
the Initiative is underway. We have issued a Request for Applications 
and have received submitted applications. In addition, we have secured 
the participation of several key industry participants. Awards will be 
made this summer, with work on the project to begin shortly thereafter. 
The study objectives are to:
  --Identify the best markers for early diagnosis of AD
  --Identify markers for following disease progression and monitoring 
        treatment response
  --Develop surrogate endpoints for clinical trials
  --Decrease time and expense of drug development
  --Establish methods for the collection, processing, and distribution 
        of neuroimaging data in conjunction with other biological, 
        clinical, and neuropsychological data
    The initiative is planned as a partnership among the NIA/NIH, 
academic investigators, the pharmaceutical and imaging equipment 
industries, the Food and Drug Administration, the Centers for Medicare 
and Medicaid Services, and the NIH Foundation, with participation from 
the Alzheimer's Association and the Institute for the Study of Aging. 
The clinical, imaging, and biological data and samples will be made 
available, with appropriate safeguards to ensure participant privacy, 
to all scientific investigators in the academic and industrial research 
communities.

                        PREVENTION AND TREATMENT

    As imaging and laboratory studies tell us more about AD's 
pathology, we are identifying a number of novel molecular 
characteristics that may prove to be targets for treating the disease 
or preventing it altogether. For example, enhancing the brain's self-
protective capacity by inducing production of naturally-occurring 
proteins that destroy beta amyloid shows promise in mice that have been 
genetically altered to produce amyloid plaques. In a recent study, 
boosting production of two proteins, insulin-degrading enzyme and 
neprilysin, in neurons of these mice reduced brain amyloid levels, 
slowed or even prevented amyloid plaque formation, and prevented their 
premature death.
    In this endeavor, animal models--particularly transgenic mice, but 
also worms, dogs, and even non-human primates--are invaluable research 
resources for studying age-related and disease-related changes in the 
brain and for testing promising interventions. For example, 
investigators recently studied the effects of an enriched diet on age-
related cognitive decline in dogs, a model that mimics the behavioral 
and brain pathological declines of older humans more closely than 
rodent models. Young and old dogs were given a series of baseline 
cognitive tests. Half of each age group then remained on a standard 
diet, while the other half of each age group was placed on a diet 
enriched with antioxidants and mitochondrial co-factors, which are 
thought to improve nerve cell energy and efficiency and decrease 
production of molecules that contribute to oxidative damage in the 
brain. Animals remained on their respective diets for six months and 
then were assessed again for cognitive performance on a variety of 
tasks. When tested, old dogs on the control diet learned more slowly 
than the young dogs and made significantly more errors; however, when 
compared to the old animals on the control diet, old animals on the 
enriched diet showed significantly better learning, although not to the 
level of the younger animals. The success of this simple, cost-
effective intervention has significant implications for dietary 
interventions that might lessen or even prevent some of the cognitive 
decline seen with age and with disease; a pilot trial of similar 
antioxidants in older Down syndrome patients who have developed AD is 
currently under way.
    In fact, NIA is currently supporting 25 AD clinical trials, 
including large-scale prevention trials, which are testing agents such 
as hormones, anti-inflammatory drugs, statins, homocysteine-lowering 
vitamins, and anti-oxidants for their effects on slowing progress of 
the disease, delaying AD's onset, or preventing the disease altogether. 
Other intervention trials are assessing the effects of various 
compounds on the behavioral symptoms (agitation, aggression, and sleep 
disorders) of people with AD.

                               CAREGIVING

    Most of the over 4 million Americans with AD today are cared for 
outside the institutional setting by an adult child or in-law, a 
spouse, another relative, or a friend. Caregivers frequently experience 
significant emotional stress, physical strain, and financial burdens, 
yet they often do not receive adequate support for their remarkable 
efforts. Several recent studies have explored the problems faced by 
caregivers of AD patients, and have sought to design interventions to 
reduce their burdens. Although family caregiving has been extensively 
studied, there has been less research on the impact of end-of-patient-
life on caregivers who are family members of persons with dementia or 
to the caregivers' responses to the death of the patient. As part of 
the NIA's Resources for Enhancing Alzheimer's Caregiver Health (REACH) 
study, a multisite randomized clinical intervention of 1,222 caregiver 
and recipient dyads, investigators assessed the type and intensity of 
care provided by 217 family caregivers to persons with dementia during 
the year before the patient's death, as well as the caregivers' 
responses to the death. Additionally, this group was compared to the 
180 caregivers who institutionalized their family member. The 
researchers found that the in-home caregivers reported tremendous 
levels of stress in the year leading up to the care recipient's death, 
and that levels of caregiver depression ``spiked'' immediately 
following the care recipient death. However, the caregivers in this 
study demonstrated tremendous resilience: Within fifteen weeks of the 
recipient's death, depression returned to pre-death levels, and within 
one year, depression was significantly lower than prior to the care 
recipients' death. Importantly, caregiver depression for those placing 
their loved ones in an institution was slightly higher both pre- and 
post-death than for those caring for the patient at home. These 
findings suggest that interventions for caregiver support are 
particularly critical in the periods immediately prior to and 
immediately after the patient's death.
    The NIA's REACH Project, a large, multi-site intervention study of 
family caregivers of AD patients, was designed to characterize and test 
promising interventions for enhancing family caregiving. Nine different 
social and behavioral interventions were tested, and investigators 
found that the combined effect of certain interventions alleviated 
caregiver burden, and that certain specific interventions, such as 
structured family therapy, reduced depression. The second phase of the 
study, REACH II, combines elements of the diverse interventions tested 
in REACH into a single multi-component psychosocial intervention and is 
ongoing.

                               CONCLUSION

    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 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.

    Senator DeWine. Doctor, I think what we are going to do is 
to ask you to wait. We have several other Senators who, I know, 
want to ask questions. And if we could excuse you just for a 
moment we are going to put our second panel on and then we will 
have your questions. Thank you very much.
    Let me introduce our second panel at this point. Sheldon 
Goldberg joined the Alzheimer's Association as its present 
chief executive officer on December 1, 2002. Previously Mr. 
Goldberg was the president and CEO of the Jewish Home and 
Hospital in New York. He holds a B.S. in Educational Psychology 
from the University of Wisconsin.
    Denis Kroucik was an electronics repairman at a steel plant 
in Lorraine, Ohio, until he was diagnosed with Alzheimer's 
disease in 2002 at the age of 56. He is currently taking one of 
the five available Alzheimer's drugs and is participating in an 
Alzheimer's study at the Memory and Aging Center at the 
University Hospitals of Cleveland. He and his wife Barbara have 
six children and five grandchildren and they reside in O'Leary, 
Ohio.
    Johnny Orr remains the winningest coach in Iowa State 
University history, with 218 wins in his 14-season career as 
Iowa State University's men's basketball coach. Prior to his 
career in Iowa he was the men's basketball coach at the 
University of Michigan. Mr. Orr was a two-time All-American at 
Beloit College in Wisconsin and played for the NBA, St. Louis 
Bombers, and Waterloo Hawks. He is accompanied by his wife, 
Romie, who was diagnosed with Alzheimer's disease in October 
2002. Mrs. Orr was a physical education teacher prior to her 
retirement in 1980. They have been married for 55 years and 
have four daughters and six grandchildren. They reside in West 
Des Moines, Iowa.
    Phyllis Campbell is the president of the Urban League of 
Lancaster County, Pennsylvania. She received her Bachelor's 
Degree from Morgan State University and her Master's Degree 
from the University of Pennsylvania.
    David Snowden is a professor in the Department of Neurology 
in the College of Medicine in the Sanders-Brown Center on Aging 
at the University of Kentucky. He is a director of the Nun 
Study, a longitudinal study which looked at the health and 
aging of 678 members of the School Sisters of Notre Dame. Dr. 
Snowden earned his Ph.D. from the University of Minnesota. He 
is accompanied by Sister Kunkel. Sister was educated by the 
School Sisters of Notre Dame from elementary school through 
college. She received her Bachelor's Degree from the College of 
Notre Dame of Maryland, her Master's Degree from Boston 
College. She joined the School Sisters in September of 1932. In 
1990 she entered the Nun Study. Dr. Snowden devotes an entire 
chapter of his book, ``Aging With Grace,'' to Sister and her 
life's story. In that chapter she describes herself as having 
two good traits, ``I am alert and I am vertical.''
    Shelley Fabares is a National Board Member of the 
Alzheimer's Association. She starred as a television newscaster 
in television's hit comedy series, ``Coach.'' She is also well-
known for her starring roles in ``One Day at a Time'' and ``The 
Donna Reed Show.'' Today she dedicates much of her time to the 
National Alzheimer's Association. She became involved in the 
organization after caring for her mother throughout her 8-year 
battle with the disease. She has testified before this 
subcommittee in 1990, 1992 and 1993, and we certainly welcome 
her back as well. We welcome all of our witnesses.

STATEMENT OF JOHNNY ORR, HUSBAND OF ALZHEIMER'S 
            PATIENT, WEST DES MOINES, IA
ACCOMPANIED BY ROMIE ORR, ALZHEIMER'S PATIENT

    Senator DeWine. Let me start, from my left and your right, 
we will start with Mr. Orr. Pass the microphone down and make 
sure it is on. You have to push it down.
    Mr. Orr. Can you hear me?
    Senator DeWine. Very well, very well.
    Mr. Orr. Good morning, Senator DeWine and members of the 
subcommittee. Romie and I are honored to be in Washington and 
are especially glad to see our friend, Senator Harkin. We 
haven't seen him yet but I'm sure he's going to be here.
    Senator DeWine. He is coming.
    Mr. Orr. Romie and I are here today to do whatever we can 
to help the fight against Alzheimer's. Like almost everyone 
else in this hearing room, we have been touched directly by 
Alzheimer's disease. We initially became Alzheimer's advocates 
after a very good friend of ours lost his wife. She had 
Alzheimer's for 30 years. In the Fall of 2002, I was honored to 
be selected as a celebrity chair of the Alzheimer's Association 
Greater Iowa Chapter Memory Walk. And about a month after the 
Memory Walk, Romie was diagnosed with Alzheimer's. She was 73. 
This diagnosis was surprising since Romie was in great shape 
and didn't appear to have any health problems. She exercises 
regularly and had maintained an active lifestyle since retiring 
from her job as a physical education teacher in 1980. There was 
no history of Alzheimer's in her family. Although two of our 
daughters noticed that Romie occasionally had difficulty 
recalling names or events, we both assumed that that memory 
lapse was a part of the normal aging process. We mentioned the 
memory problems to Romie's physician at her annual physical in 
October 2002. A memory test indicated signs of dementia, and we 
were referred to an Alzheimer's specialist, Dr. Bender. After 
additional tests Dr. Bender concluded that Romie was in the 
early stages of Alzheimer's disease. Dr. Bender immediately 
started Romie on one of the Alzheimer's drugs currently 
available, vitamins E and C and Ginkgo Biloba. Dr. Bender also 
encouraged Romie to keep exercising, watch her diet, in 
addition to doing other activities to stimulate her brain.
    It has been about 18 months since her diagnosis and Romie 
is doing quite well. Her Alzheimer's seems to be progressing 
slowly and although she no longer drives she still cooks, buns 
once in awhile, does laundry and maintains the finances for one 
of our three homes. She plays golf, although less often than 
she has in the past, and she has no trouble keeping up with our 
six grandchildren. She reads a lot, continues to do our holiday 
cards, participates in our family gold tournament each Summer, 
we go out to dinner regularly with friends and travel between 
our homes in Iowa and Florida. She still loves basketball as 
much as I do and we're looking forward to attending the NCAA 
championship next week in San Antonio. We haven't missed a 
tournament in 48 years.
    We've learned a lot about Alzheimer's disease since Romie 
was diagnosed and we have many reasons to be hopeful. 
Significant advances in medical research have resulted in new 
and promising treatments. The Alzheimer's drug that Romie takes 
is one of five prescriptions available in pharmacies today. 
Improved diagnostic tools are helping doctors diagnose 
Alzheimer's earlier and with greater accuracy, allowing 
individuals like Romie to maintain their quality of life as 
long as possible. Scientists are engaged in additional research 
to develop strategies for slowing this progression. The goal of 
a world without Alzheimer's disease is within reach. In order 
to realize a future without Alzheimer's, we must ensure that 
the Federal Government maintains its commitment to fund 
promising research.
    Romie and I thank this committee, and especially you, 
Senator Harkin, for your outstanding leadership in the fight to 
increase funding for research at the National Institutes of 
Health. We recognize that your challenge this year is 
especially difficult and pledge to do whatever we can to help 
you continue the momentum that has brought us to this historic 
point. For our children and grandchildren, and for the families 
of people sitting in this room, we cannot afford to back down 
now. Alzheimer's is a tough opponent but we can beat it. We 
have recruited a dream team of the best scientists and we have 
a game plan that will lead us to victory. In order to execute 
this plan we need an additional $40 million in funding this 
year for clinical trials to identify treatments that can slow 
or halt the onset and progression of Alzheimer's.
    On behalf of our entire family, Senator DeWine, we thank 
you for giving us the opportunity to be here today. And Romie 
would now like to say a few words to conclude our testimony.
    Senator DeWine. Good. Thank you very much. Mrs. Orr.

                     SUMMARY STATEMENT OF ROMIE ORR

    Mrs. Orr. Good morning.
    Senator DeWine. Good morning.
    Mrs. Orr. I'm here today because I'm the patient, I'm the 
one that has it. My diagnosis, I was lucky. You know, you've 
got to get a diagnosis first. And that's not easy because 
there's no finite way to say this one has it, this one doesn't. 
Charles Coughlin and Robert Bender, both of Des Moines, 
together diagnosed me with my Alzheimer's disease. Our two 
youngest daughters went with their dad and I to see these 
doctors and they were right there when we got the message. But 
my family is represented today even though neither of the 
doctors could be here. You've met my husband John, our daughter 
Jennifer Davis of Lemont, Illinois, daughter Leslie Boylen and 
her daughter, Rachel, Laurens, Iowa, daughter Becky Montgomery 
and her son Jamie of Anthon, Iowa.

                           PREPARED STATEMENT

    When my Alzheimer's diagnosis was made I didn't feel my 
life had fallen apart. I decided, as Johnny told you, not to 
drive but I can swim, I can golf and because of my strong 
medicine I do walk with the craziest gait you ever saw. It's a 
very wide stride so I can keep my balance and not fall over. I 
don't want any other Alzheimer's patient to stop living or to 
be afraid or depressed or needing to change their life's goals. 
I may or may not be a typical patient but I am lucky. With good 
doctors, good medicine and a desire to help others with this 
disease. I'm here to ask Congress to help their constituents 
legislation that will help find that help.
    Do you have any questions?
    Senator DeWine. Mrs. Orr, thank you very much.
    Mrs. Orr. Thank you very much for having me.
    [The statement follows:]

                    Prepared Statement of Johnny Orr

    Good morning Senator Harkin, Senator DeWine and members of the 
Subcommittee. Romie and I are honored to be in Washington and are 
especially glad to see our good friend, Senator Harkin, once again.
    Romie and I are here today to do whatever we can to help in the 
fight against Alzheimer's. Like almost everyone else in this hearing 
room, we have been touched directly by Alzheimer's disease. We 
initially became Alzheimer advocates after a very good friend of mine 
lost his wife to the disease. In the fall of 2002, I was honored to be 
selected as the celebrity chair of the Alzheimer's Association Greater 
Iowa Chapter Memory Walk. About a month after the Memory Walk, Romie 
was diagnosed with Alzheimer's disease. She was 73 years old.
    The diagnosis was surprising since Romie was in great shape and 
didn't appear to be having any health problems. She exercised regularly 
and had maintained an active lifestyle since retiring from her job as a 
physical education teacher in 1980. There was no history of Alzheimer's 
disease in her family. Although two of our daughters noticed that Romie 
occasionally had difficulty recalling names or events, we both assumed 
that the memory lapses were part of the normal aging process. We 
mentioned the memory problems to Romie's general physician at her 
annual physical in October 2002. A memory test indicated signs of 
dementia and we were referred to an Alzheimer's specialist named Dr. 
Bender. After additional tests, Dr. Bender concluded that Romie was in 
the early stages of Alzheimer's disease.
    Dr. Bender immediately started Romie on one of the Alzheimer drugs 
currently available, vitamins E and C and ginko biloba. Dr. Bender also 
encouraged Romie to keep exercising and watch her diet, in addition to 
doing activities to stimulate her brain.
    It has been about 18 months since her diagnosis and Romie is doing 
quite well. Her Alzheimer's seems to be progressing slowly. Although 
she no longer drives, she still cooks, does laundry and maintains the 
finances for one of our three homes. She plays golf, although less 
often than she has in the past, and has no trouble keeping up with our 
six grandchildren. She reads a lot, continues to do our holiday cards 
and participates in our family golf tournament each summer. We go out 
to dinner regularly with friends and travel between our homes in Iowa 
and Florida. Romie may not be able to recall what we had for lunch but 
she easily remembers basketball games from my days at Michigan and Iowa 
State. She still loves basketball almost as much as I do and we're 
looking forward to attending the NCAA championship in a few weeks. We 
haven't missed an NCAA tournament in 48 years.
    We've learned a lot about Alzheimer's disease since Romie was 
diagnosed and we have many reasons to be hopeful. Significant advances 
in medical research have resulted in new and promising treatments. The 
Alzheimer drug that Romie takes is one of five prescriptions available 
in pharmacies today. Improved diagnostic tools are helping doctors 
diagnose Alzheimer's earlier and with greater accuracy, allowing 
individuals like Romie to maintain their quality of life for as long as 
possible. Scientists are engaged in additional research to develop 
strategies for slowing the progression of the disease process. The goal 
of a world without Alzheimer's disease is within reach.
    In order to realize a future without Alzheimer's disease, we must 
ensure that the federal government maintains its commitment to fund 
promising research. Romie and I thank this committee and especially you 
Senator Harkin for your outstanding leadership in the fight to increase 
funding for research at the National Institutes of Health. We recognize 
that your challenge this year is especially difficult and pledge to do 
whatever we can to help you continue the momentum that has brought us 
to this historic point. For our children and grandchildren and for the 
families of the people sitting in this room, we cannot afford to back 
down now.
    I faced a lot of tough opponents in 44 years of coaching and I'm 
proud to say that I never lost a game without a fight. Alzheimer's is a 
tough opponent but we can beat it. We have recruited a dream team of 
the best scientists and we have a gameplan that will lead us to 
victory. In order to execute this gameplan, we need an additional $40 
million in funding this year for clinical trials to identify treatments 
that can slow or halt the onset and progression of Alzheimer's disease.
    On behalf of our entire family, we thank you for giving us the 
opportunity to be here today. Romie would now like to say a few words 
to conclude our testimony.

    Senator DeWine. We will go through the whole panel and then 
we will have some questions. We appreciate you and Mr. Orr 
being here very much.
    Mrs. Orr. Thank you.
    Senator DeWine. Mr. Kroucik. Thank you for joining us.

STATEMENT OF DENNIS KROUCIK, ALZHEIMER'S PATIENT, 
            ELRYIA, OH
    Mr. Kroucik. Thank you for having me. Good morning, Senator 
DeWine. My name is Denis Kroucik. I am honored to be here 
representing the great State of Ohio and the Cleveland area 
chapter of Alzheimer's.
    Two years ago, at age 56, I was diagnosed with Alzheimer's 
disease. The 3 years prior to my diagnosis were frustrating and 
scary for me. I had always enjoyed gardening and was good at 
it. I suddenly found it was taking me a whole day to complete 
my work when normally it would only take me a few hours. I was 
also having trouble at work. At the time I was an electrician 
at a steel plant in Lorraine. I would get lost walking around 
the plant, couldn't find my way out; I missed routine items on 
my safety checklist and couldn't remember my children's names 
anymore when co-workers would ask me how they were doing. There 
were times I drove home from work at night after working 
overtime and I couldn't find my way home. I had to follow other 
traffic, hoping I would find my way home. I thought my problems 
were caused by lack of sleep, job-related stress because there 
were rumors that our plant would be closing and I would lose my 
job. And I am also a diabetic and for awhile my wife, Barb, 
thought that the problem with fatigue and memory problems were 
due to low blood sugar. Barb kept on encouraging me to see a 
doctor but I kept on putting it off out of embarrassment. I 
figured that it was normal to have memory lapses at my age, 
even though it was early 50s.
    The turning point came one day at work. I was going through 
a routine checklist and forgot to lock out a 13,800 volt bus 
supply. I nearly electrocuted myself and a fellow employee. 
Barb put me in the car the next day and took me to the doctor 
immediately. A week later, after a battery of psychological 
tests and an MRI, a neurologist gave me the terrible news, 
``You have Alzheimer's disease.'' The changes in my life were 
very swift and immediate. I lost my job, had to give up my car 
keys. I felt humiliated, useless and I didn't even want to get 
up in the morning. I felt like a little kid, wondering if Barb 
was going to have to take care of me like my mother once did. I 
was angry, depressed, scared and I was losing my independence. 
It was a terrible tragedy.
    My doctor put me on a newer Alzheimer's drug as well as B-
12, Vitamin E, Ibuprofen. The Alzheimer's drug made such a 
difference in my life. I felt human again. Barb and I contacted 
the Cleveland area chapter of Alzheimer's Association. The 
people at this chapter were so nice and understanding of what 
both of us were going through. They helped us learn a lot about 
the disease and how it could be treated. I realized then that I 
could have a life after Alzheimer's.
    Today I work out at the local YMCA twice a week, a friend 
drops me off, picks me up. Barb watches me as well; she quit 
her job as a furniture salesperson last year so she could spend 
more time together with us. Sometimes I get very caught up in 
what I'm doing and at times I lose track of time. Barb reminds 
me to stop, take a break, have something to eat. I need 
especially to be careful because of my diabetes. I am very 
active at the Cleveland chapter of Alzheimer's; 2 weeks ago I 
spoke at an Alzheimer's legislation in Columbus for the 
Alzheimer's Consul Memory Day.

                           PREPARED STATEMENT

    I came to Washington today to testify in this hearing for 
many reasons. The most important reasons are my wife, my six 
children, and my five grandchildren. I just hope and pray that 
I am the only person in my family to experience what it's like 
to live with Alzheimer's disease. I am encouraged by the 
progress that has been achieved in the fight against this 
terrible disease. New research is coming out every day. My 
doctors think that we will soon be able to slow the progression 
of the disease and the process and postpone the onset of this 
risk if the funding for the research keeps pace with the 
scientific momentum. I am grateful for the Federal dollars that 
have been spent on Alzheimer's research so far and I encourage 
this committee to continue to increase the funding for the 
research. It won't be easy given the current budget situation. 
However, it is something we have to do. We can't afford to 
wait. I am participating in an Alzheimer's study in the 
University of Memory and Aging at the University Hospitals in 
Cleveland. What will happen if the funding of this study is 
cut? How many more scientific opportunities will be lost if 
Congress decides that we can't afford to increase the funding 
for Alzheimer's research? How many more lives will be lost in 
this disease?
    I want to thank Senator DeWine for inviting me to speak 
today. It is an honor to be here and I am happy to answer any 
questions you might have.
    [The statement follows:]

                  Prepared Statement of Dennis Kroucik

    Good morning Senator DeWine and Senator Harkin. My name is Dennis 
Kroucik. I am honored to be here today representing the great state of 
Ohio and the Cleveland Area chapter of the Alzheimer's Association.
    Two years ago, at age 56, I was diagnosed with Alzheimer's disease. 
The three years prior to my diagnosis were frustrating and scary. I had 
always enjoyed gardening and was good at it. I suddenly found that it 
was taking me a whole day to complete a gardening chore that used to 
take only a few hours. I was also having trouble at work. At the time I 
was an electrician at a steel plant in Lorain. I would get lost walking 
around the plant. I'd miss routine items on my safety checklist and 
couldn't remember my children's names when coworkers asked how they 
were doing. There were times that I drove home from work at night by 
following traffic because I couldn't remember how to get from the plant 
to our house. I thought that my problems were caused by lack of sleep 
or job-related stress. There were rumors that the plant would be 
closing and we'd all lose our jobs. I am also diabetic and for awhile, 
my wife Barb and I thought that the fatigue and memory problems were 
due to low blood sugar. Barb kept encouraging me to see a doctor but I 
put it off. I figured that it was normal to have memory lapses at my 
age.
    The turning point came one day at work. I was going through a 
routine safety checklist and forgot to lock-out a 13,800-volt machine. 
I nearly electrocuted myself. Barb put me in the car the next day and 
took me to the doctor. A week later, after a battery of psychological 
tests and an MRI, a neurologist gave me the terrible news. I had 
Alzheimer's disease.
    The changes in my life were swift and immediate. I lost my job and 
had to give up my car keys. I felt humiliated and useless. I didn't 
want to get up in the morning. I felt like a little kid and wondered if 
Barb was going to have to take care of me like my mother once did. I 
was angry and depressed and scared that I would lose my independence. 
It was a terrible tragedy.
    My doctor put me on one of the newer Alzheimer drugs, as well as a 
B-12 complex, vitamin E and Ibuprofen. The Alzheimer drug made such a 
huge difference. I felt human again. Barb and I contacted the Cleveland 
Area chapter of the Alzheimer's Association. The people at the chapter 
were so nice and understood what we were both going through. They 
helped us learn a lot about the disease and how it could be treated. I 
realized that I could have a life after Alzheimer's disease.
    Today I workout at the local YMCA twice a week. A friend drops me 
off and picks me up. Barb watches out for me as well. She quit her job 
as a furniture salesperson last year so that we could spend more time 
together. Sometimes I get very caught up in what I am doing and lose 
track of time. Barb reminds me to stop and take a break or have 
something to eat. I need to be especially careful about eating because 
of my diabetes. I am very active with the Cleveland Area chapter of the 
Alzheimer's Association. Two weeks ago I spoke before more than 100 
Ohio legislators at the Alzheimer's Ohio Council Memory Day in 
Columbus.
    I came to Washington to testify at this hearing for many reasons. 
The most important reasons are my wife, my six children and my five 
grandchildren. I hope and pray that I am the only person in my family 
who will experience what it is like to live with Alzheimer's disease. I 
am encouraged by the progress that has been achieved in the fight 
against this terrible disease. New research is coming out everyday. My 
doctors think that we will soon be able to slow the progression of the 
disease process and postpone onset in those at risk if the funding for 
research keeps pace with the scientific momentum. I am grateful for the 
federal dollars that have been spent on Alzheimer research so far and 
encourage this committee to continue to increase the funding for 
research. It won't be easy given the current budget situation. However, 
it is something we have to do. We cannot afford to wait. I am 
participating in an Alzheimer research study at the University Memory 
and Aging Center through the University Hospitals of Cleveland. What 
will happen if funding for the study is cut? How many other scientific 
opportunities will be lost if Congress decides that we cannot afford to 
increase funding for Alzheimer research this year? How many more lives 
will be lost to Alzheimer's disease?
    I want to thank you Senator DeWine for inviting me to speak today. 
It is an honor to be here and I am happy to answer any questions you 
may have.

    Senator DeWine. Thank you very much.
    Ms. Fabares.

STATEMENT OF SHELLEY FABARES, NATIONAL BOARD MEMBER, 
            ALZHEIMER'S ASSOCIATION, STUDIO CITY, CA
    Ms. Fabares. Thank you, Senator DeWine and Senator Harkin, 
when you get here, nice to see you, and members of the 
subcommittee. Thank you for inviting me to testify today on so 
important a subject.
    Like so many people in this hearing room I have been 
touched directly by Alzheimer's disease. My mother Elsa Rose 
Fabares, died of this hideous illness in September 1992 after 
suffering for 8 long years from the fear, confusion, dread, 
increasing incoherence, and ultimately infantile state that it 
so often produces. But I'm here today, not only as a family 
member; in a way I'm also here as this panel's historian. I 
first testified as you said, before Congress about Alzheimer's 
disease in 1990 and the last time was actually in 1995, nearly 
a decade ago. In the interim I've been struggling with my own 
health issues, a hip replacement and liver transplant, and the 
time and attention they require. I am happy to report that I am 
now feeling great and I am thrilled to be able to come to 
Washington again to speak on behalf of the millions of 
individuals and families who are dealing with this disease day 
in and day out.
    Looking back over the past 10 years I am in awe at what has 
been accomplished and I am keenly aware that this progress has 
been made possible by the support you and the Alzheimer's 
Association have given to solving the puzzle of Alzheimer's. To 
highlight just a few of the remarkable advances achieved, 
though some have already been mentioned, the concepts of cure 
and prevention, inconceivable 10 years ago are now real 
possibilities. Four treatments have been approved by the FDA 
and 20 trials are underway with widely used drugs like 
Ibuprofen and Vitamin E that might reduce the risk of 
Alzheimer's. We can now diagnose, with a high degree of 
accuracy and at much earlier stages of the disease when 
available treatments are likely to be the most effective. 
That's why people with Alzheimer's, like Frank Carlino, who 
testified several years ago, and Mrs. Orr, today are able to 
come before you and speak for themselves. Knowledge of the 
biology of this disease has opened doors to the possibility of 
a vaccine that might fight the toxic proteins that cause 
Alzheimer's. Scientists are closing in on the search for 
markers that will identify its development long before symptoms 
appear, a key to speeding drug trials and targeting new 
medications to those who really need them. And research on 
therapies and care giving strategies, as well as on the effects 
of lifestyle in maintaining cognitive function all promise to 
extend independence and keep brains healthy and functioning 
longer.
    When all these accomplishments are added up it is clear 
that your investment in research is paying off hugely. 
Scientists who are by nature cautious and skeptical are now 
positively exuberant about the promise of prevention and 
treatments that will stop or substantially delay this disease. 
While they won't be pinned down on a date, most are quite 
optimistic that it can and will be done and probably sooner 
than they imagined. There is now enough hope and solid 
scientific backing for the Alzheimer's Association to launch 
its ``Maintain Your Brain'' campaign. This campaign draws on 
scientific evidence linking cardiovascular disease and 
Alzheimer's and suggests some relatively simple things people 
can do to keep their brains, as well as their bodies, healthy. 
This too is evidence of the value of our investments in 
research over the past 10 years.
    I've spent a lot of time traveling around the country 
talking to individuals and families who are dealing with 
Alzheimer's disease. A few have been able to come to Washington 
to tell their own stories, like Christine Frey, from Peoria, 
Illinois, who talked about her seven relatives who've already 
died from the disease and how it hangs like a death sentence 
over her own life. Like Maureen Reagan, or 10-year-old Walter 
Dawson of Falls City, Oregon, whose father's Alzheimer's 
disease jeopardized his future. Or Catherine Brewer of 
Northport, New York, or Beverly Hines of Vassalboro, Maine, who 
both suffered terrible stress-related illnesses directly linked 
to their care giving responsibilities.
    Now, because of better diagnostic tools, more people with 
the disease are speaking up and speaking out for themselves. No 
one is better able to convey the urgency or our research 
efforts than someone living with Alzheimer's and talking to us 
in her own voice. And the voices, sadly, are increasing in 
numbers, leaving few families untouched. The Coalition of Hope 
that we are going to be announcing today is further evidence of 
the growing chorus of Americans who are no longer willing to 
sit on the sidelines and allow this disease to consume our 
families and our Nation with its voracious and destructive 
appetite. The Coalition members understand all too well that if 
we don't continue our commitment to Alzheimer's research we 
face a bleak future indeed.
    Mr. Chairman, when I was last here science was just 
building the caissons on either side of this vast Alzheimer's 
river. These caissons that would form the foundation for a 
scientific bridge that someday will allow us to surmount the 
human destruction caused by this river. But the bridge is not 
complete and the river's rush continues to consume millions of 
lives. We are well within striking distance and we can finish 
the bridge but only if we maintain our investment in research. 
Would the public sit by quietly if we were to stop construction 
on any of Nation's major bridges when they were 50 to 80 
percent finished? Of course not. Nor will they nor can they sit 
by if we shift our attention away from completing the job of 
Alzheimer's disease when we are so close. The millions of 
victims past, present and future demand that the job be 
finished and the sooner the better. The consequence of success 
are huge, the consequences of failure too horrific to 
comprehend.

                           PREPARED STATEMENT

    For Mrs. Orr and her children, for Christine Frey and 
Walter Dawson and Frank Carlino, for our parents, our children 
and ourselves, we urge you to please stay the course so we can 
someday have a world without Alzheimer's.
    Thank you very much.
    [The statement follows:]

                 Prepared Statement of Shelley Fabares

    Mr. DeWine, Senator Harkin, members of the Subcommittee. Thank you 
for inviting me to testify today on so important a subject.
    Like so many people in this hearing room, I have been touched 
directly by Alzheimer's disease. My mother, Elsa Rose Fabares, died of 
this hideous illness in September of 1992 after suffering for eight 
long years from the fear, confusion, dread, increasing incoherence and 
ultimately infantile state that it so often produces.
    But, I'm here today not only as a family member. In a way I'm also 
here as the panel's historian. I first testified before Congress about 
Alzheimer's disease in 1990, and the last time was in 1995, nearly a 
decade ago.
    In the interim, I've been struggling with my own health issues--a 
hip replacement and liver transplant--and the time and attention they 
require. I'm happy to report that I'm now feeling great and am 
delighted to be able to come to Washington again to speak on behalf of 
the millions of individuals and families who are dealing with this 
disease day in and day out.
    Looking back over the past 10 years, I am in awe at what has been 
accomplished. And I'm keenly aware that this progress has been made 
possible by the support you and the Alzheimer's Association have given 
to solving the puzzle of Alzheimer's. To highlight just a few of the 
remarkable advances achieved:
  --The concepts of cure and prevention, inconceivable 10 years ago, 
        are now real possibilities.
  --Four treatments have been approved by the FDA and twenty trials are 
        underway with widely used drugs, like ibuprofen and Vitamin E, 
        that might reduce the risk of Alzheimer's.
  --We can now diagnose with a high degree of accuracy, and at much 
        earlier stages of the disease--when available treatments are 
        likely to be most effective. That's why people with 
        Alzheimer's, like Frank Carlino who testified several years 
        ago, and Mrs. Orr today are able to come before you and speak 
        for themselves.
  --Knowledge of the biology of this disease has opened doors to the 
        possibility of a vaccine that might fight the toxic proteins 
        that cause Alzheimer's.
  --Scientists are closing in on the search for markers that will 
        identify its development long before symptoms appear--a key to 
        speeding drug trials and targeting new medications to those who 
        really need them.
  --And, research on therapies and caregiving strategies, as well as on 
        the effects of lifestyle in maintaining cognitive function, all 
        promise to extend independence and keep brains healthy and 
        functioning longer.
    When all these accomplishments are added up, it is clear that your 
investment in research is paying off hugely. Scientists, who are by 
nature cautious and skeptical, are now positively exuberant about the 
promise of prevention and treatments that will stop or substantially 
delay this disease. While they won't be pinned down on a date, most are 
quite optimistic that it can and will be done, and probably sooner than 
we ever imagined.
    There is now enough hope and solid scientific backing for the 
Alzheimer's Association to launch its ``Maintain Your Brain'' campaign. 
This campaign draws on scientific evidence linking cardiovascular 
disease and Alzheimer's, and suggests some relatively simple things 
people can do to keep their brains as well as their bodies healthy. 
This, too, is evidence of the value of our investments in research over 
the past 10 years.
    I've spent a lot of time traveling around the country talking to 
individuals and families who are dealing with Alzheimer's disease. A 
few have been able to come to Washington to tell their own stories, 
like Christine Frey from Peoria, Illinois, who talked about her seven 
relatives who've already died from the disease and how it hangs like a 
death sentence over her own life. Like Maureen Reagan. Or 10 year-old 
Walter Dawson of Falls City, Oregon, who father's Alzheimer's disease 
jeopardized his future. Or Catherine Brewer of Northport, New York, or 
Beverly Hines of Vassalboro, Maine, who suffered terrible stress-
related illnesses directly linked to their caregiving responsibilities.
    And, now because of better diagnostic tools, more people with the 
disease are speaking up and speaking out for themselves. No one is 
better able to convey the urgency of our research efforts than someone 
living with Alzheimer's and talking to us in her own voice.
    And the voices, sadly, are increasing in numbers, leaving few 
families untouched. The Coalition of Hope that we are announcing today 
is further evidence of the growing chorus of Americans who are no 
longer willing to sit on the sidelines and allow this disease to 
consume our families and our nation with its voracious and destructive 
appetite. The coalition members understand all too well that if we 
don't continue our commitment to Alzheimer's research we face a bleak 
future indeed.
    Mr. Chairman, when I was last here, science was just building the 
caissons on either side of this vast Alzheimer's river, these caissons 
that would form the foundation for a scientific bridge that someday 
will allow us to surmount the human destruction caused by this river. 
But, the bridge is not complete and the river's rush continues to 
consume millions of lives. We are well within striking distance and we 
can finish the bridge, but only if we maintain our investment in 
research.
    Would the public would sit by quietly if we were to stop 
construction on any of our nation's major bridges when they were 50 
percent or 80 percent finished? Of course not. Nor will they--nor can 
they--sit by if we shift our attention away from completing the job on 
Alzheimer's disease when we are so close. The millions of victims--
past, present and future--demand that the job be finished, and the 
sooner the better. The consequences of success are huge; the 
consequences of failure too horrific to comprehend.
    For Mrs. Orr and her children, for Christine Frye and Walter Dawson 
and Frank Carlino . . . for our parents, our children and ourselves, we 
urge you to please stay the course so we can someday have a world 
without Alzheimer's disease.

    Senator DeWine. Thank you very much. Mr. Goldberg.

STATEMENT OF SHELDON GOLDBERG, PRESIDENT AND CEO, 
            ALZHEIMER'S ASSOCIATION, CHICAGO, IL
    Mr. Goldberg. Thank you Senator DeWine, Senator Harkin. I 
appreciate the opportunity to again appear before this 
committee. And I again remind you I am privileged to be part of 
the Alzheimer's Association and serve as its president.
    As you may well know, the goal of the Alzheimer's 
Association is very singular in purpose. It is to provide to 
care and support but also and perhaps more importantly to find 
a cure for this disease to create the world without Alzheimer's 
disease. And I am privileged to come and tell you that we can 
now start communicating to our public that there is progress 
being made and the possibility even exists that we can see the 
time when we can find a way of stopping this disease. And that 
is a direct result of research.
    Senators, it is because of you, it is you have led the 
charge, it is you who have had the vision, it is you who have 
provided the funds to provide the research, and we appreciate 
it greatly. And I think you're seeing some of the results of 
that research. There are successes and there is a very 
optimistic future to go ahead. And so I am privileged to be 
able to convey to the American people, on behalf of the 
Alzheimer's Association that tremendous hope exists that we can 
defeat this disease in the time to come.
    I am privileged to also introduce to you today and 
introduce again to our public a new coalition. And this 
coalition has come together and it represents at this time 60 
million Americans, over 150 organizations and growing on a 
daily basis. And it includes the usual organizations to some 
degree. Certainly the Older Women's League is a member, 
certainly Family Care givers Alliance, the National Center on 
Black Aging, AARP, and the National Association of Retired 
Federal Employees. But I have to tell you that this coalition 
is just beginning and its taken on a whole new crew of 
suspects. And let me share some of the names.
    The Philadelphia Grange has joined us. And the Iowa Egg and 
Milk Producers have signed on, as this is their cause. The 
Kentucky Farm Bureau has joined us. The Idaho Fraternal Order 
of Police. The Tennessee Firemen's Association, the Mississippi 
School Administrators, the Indian Tribes of Alaska, the Urban 
League, the NAACP, LULAC, the American Baptist Church, 
Presbyterian Congregations, Catholic Congregations, Episcopal 
Congregations, Jewish Congregations and the list goes on and 
on. We've been joined by union locals from Teamsters and 
Electrical Workers, to State legislators and to representatives 
of county government. To the Sons of Italy and to the Polish 
American Congress. And this is just to mention a very few of 
the organizations that have joined us and I promise you that 
many more will be joining us in this movement to find a way of 
curing this disease.
    You know, it's interesting, why would they join this cause? 
Why would these new suspects come to the cause of Alzheimer's 
where traditionally it has been an aging cause? And that is 
very simple. This disease touches so many peoples' lives. It 
touches families, it touches communities and it destroys 
individual lives. And people are beginning to realize very 
clearly it does not recognize race, it does not recognize 
income, it does not recognize where you live, it doesn't pay 
attention to your occupation. It is evident that presidents 
will get this disease and have gotten this disease, and people 
from all positions in life are suffering from this disease. And 
these organizations are joining us in our fight to find a way 
of curing this disease. The movement wishes to accomplish one 
thing, and that is to ensure that Alzheimer's is not inevitable 
and that Alzheimer's is not hopeless and that the research 
continues. They simply know that their families and their 
communities and their basic economic security is being 
undermined and that is the reason these organizations have come 
together. They clearly understand that it is bankrupting our 
Federal Government, and I mean by that, its impact on Medicare 
and its impact on Medicaid. They see very clearly that it is 
draining millions, billions of dollars from American industry 
and it is destroying the retirement security that people feel 
and the serenity that they feel in their lives.
    You noted that there are 4.5 million Americans today 
afflicted with this and countless family members, and these 
numbers are going to grow geometrically as the baby boomers 
begin to--as we see the iceberg of the baby boomers coming down 
because we are only seeing the tip of the iceberg at this point 
in time. The baby boomers will have a tremendous impact as we 
move into this century and this disease will cause tremendous 
havoc, both on these individuals' family, on the health care 
and the American business which we all want to flourish and 
succeed. And that is the reason the Coalition has come 
together.
    We are very, very concerned that the funding which you have 
started and the leadership from this Committee and the leader 
from this body continue. We are asking this body to continue 
with at least $40 million to continue the research that has 
been started, to continue the progress of finding a solution, 
to finding a cure to this horrible disease. I promise you that 
this Coalition will only grow stronger, it will become more and 
more of a movement as more and more people understand the 
dimensions and the impact this disease is having on our 
society, on our government, on our industry and all the 
destruction it causes on the families.

                           PREPARED STATEMENT

    So on behalf of the Alzheimer's Association, and I say on 
behalf of this Coalition of Hope, which represents countless 
American people, we thank you for your leadership and we ask 
for your support and continue the funding and increasing the 
research.
    Thank you very much, Senators.
    [The statement follows:]

                 Prepared Statement of Sheldon Goldberg

    Senator DeWine, Senator Harkin. Thank you for inviting me back to 
talk to you about Alzheimer's disease. I am even more excited to be 
here today than I was last year at this time.
    The Alzheimer's Association's goal of delaying the disabling 
symptoms of Alzheimer's disease, and eventually preventing the disease 
now appears possible. For the first time, creating ``A World Without 
Alzheimer's'' is within reach. And it's because of you--your vision in 
claiming the Alzheimer research agenda and your steady, sustained 
commitment to moving it forward.
    Because of your leadership, we can go to the American people now 
with a new message of hope. We can--we will--have a future where 
Alzheimer's disease is only a memory.
    This morning, I speak not just for the Alzheimer's Association but 
also on behalf of a new Coalition of Hope, which we are announcing 
today.
    This is a coalition of over 150 organizations, representing more 
than 50 million Americans, who have joined the fight against 
Alzheimer's disease. You can count on us to support of your efforts to 
increase funding for Alzheimer research and services.
    The Coalition includes groups you might expect to see--the Older 
Women's League, the Family Caregiving Alliance, the National Center and 
Caucus on Black Aging, AARP, the National Association of Retired 
Federal Employees. We are grateful for their support.
    But this movement extends far beyond the aging community. Take a 
close look. It includes, for example:
  --The Pennsylvania Grange, Iowa Eggs and Milk Producers, and the 
        Kentucky Farm Bureau,
  --The Idaho Fraternal Order of Police and the Tennessee Firemen's 
        Association,
  --The Mississippi Association of School Administrators,
  --The Indian Tribes of Alaska, the Urban League, the NAACP and LULAC,
  --Southern Baptist, Catholic, Episcopal, Jewish, Assembly of God, 
        Presbyterian, and Assembly of God Congregations,
  --Locals of the International Brotherhood of Electrical Workers and 
        Teamsters,
  --State legislators and county governments, and
  --The Sons of Italy and the Polish American Congress.
    Why, one might ask, have all these ``unlikely suspects'' made 
Alzheimer's their cause. They have joined us in the fight against 
Alzheimer's because it's a disease that touches so many families and 
communities. It doesn't recognize race or income, or whether you live 
in a big city or small town. But for the first time ever there's hope 
to significantly delay the onset of the disease and lessen its impact. 
These organizations have joined us to ensure that Alzheimer's disease 
need not be inevitable or hopeless.
    But left unchecked, Alzheimer's will undermine our families, 
communities, and basic economic security.
    It will overwhelm our health care system, bankrupt Medicare and 
Medicaid, drain billions of dollars from American business, and destroy 
retirement security for tens of millions of families.
  --Today, 4.5 million Americans and their families are already facing 
        Alzheimer's, with all of its emotional and financial 
        devastation.
  --Millions of workers are leaving their jobs or cutting back work to 
        provide Alzheimer care. That lost productivity is the major 
        reason why Alzheimer's is costing American businesses an 
        estimated $61 billion.
  --Medicare is spending 3 times more on beneficiaries with Alzheimer's 
        disease. Six years from now, Alzheimer's will cost the program 
        $50 billion.
  --State Medicaid programs are spending $18 billion to help people 
        with dementia pay for their nursing homes. That will bill be 80 
        percent greater by 2010.
    But this is all just the tip of the iceberg. The babyboomers are 
still below the surface. When Alzheimer's starts to hit them, the 
numbers will begin to skyrocket. By the middle of the century, 11 to 16 
million could have the disease. We will not be able to withstand the 
explosion of costs--to families, to taxpayers, to the health care 
system, to American business.
    The Coalition of Hope is organized to make sure that does not 
happen. If the current pace and momentum is maintained we may be able 
to delay the onset and progression of the Alzheimer's as well as 
prevent the disease, saving not only billions of dollars to our health 
care system but also saving millions of lives. The baby boomers may 
indeed be the first generation not having to face Alzheimer's.
    But for those who may still get it, we will slow its progression 
enough that most will never reach the advanced stages of the disease. 
That means we will no longer have nursing homes filled with people with 
dementia.
    This is not the time to tell the scientists to slow down. But that 
is exactly what will happen unless we continue to expand the public 
investment in Alzheimer research.
    I am not a scientist, but I have spent a lot of time talking with 
scientists. Let me give you just a few examples of the opportunities we 
will miss if we stick with current and proposed funding levels:
  --Thanks to your investment, the best scientists in the world are 
        chomping at the Alzheimer bit--and that means NIA is receiving 
        record numbers of applications. But at current budgets, they 
        will be able to fund only about 15 percent of those proposals--
        for less than the 20-25 percent of past years. And they can 
        only do that much by cutting $1 of every $5 out of the 
        successful grants. Think how many scientific opportunities we 
        are missing.
  --Even existing, highly productive program projects are at risk. The 
        Healthy Aging and Dementia project at Washington University in 
        St. Louis is just one example. This is the team that created 
        the assessment instrument that is now the clinical standard. 
        They discovered with others the concept of mild cognitive 
        impairment. Now they have turned to the next critical question 
        in Alzheimer prevention--how to identify ``normal'' adults who 
        are at high risk, so we can treat them in time. The St. Louis 
        team started recruiting people in their 40s and 50s whose 
        parent had Alzheimer's. These volunteers have been through a 
        lot already--blood draws, lumbar punctures, and MRIs. But they 
        are going to have to put that study on hold, because NIA is 
        cutting their approved budget by 30 percent.
  --What about the large scale clinical trials that have been so much 
        the focus of this Committee's concern? After all, research 
        doesn't mean a lot in the real world until we are successful in 
        getting science from the bench to the bedside.
    --Scientists at the University of California in San Diego are 
            poised to start the next big trial of combinations of anti-
            oxidants. This offers one of the most exciting 
            possibilities for a safe and relatively inexpensive way to 
            protect against Alzheimer's. But NIA does not have the 
            money to get it started.
    --Even trials that are well underway--like the ginko biloba trial 
            Dr. DeKosky testified to this Committee about--will have to 
            be slowed down. There may be no money to analyze the data 
            that has already been collected on the hundreds of 
            volunteers who have participated in this trial.
    This is a travesty. We cannot let it happen.
    We know you face many competing priorities, with very little 
discretionary money in the budget.
    We understand that, after doubling the NIH budget, there are those 
who are ready to say, ``we've done enough.''
    But if we slow down now, we will be throwing away much of the 
investment the American taxpayers have already made in Alzheimer 
research.
    We must continue, and build on, the progress of the last twenty 
years.
    We are asking you to increase funding for Alzheimer research by $40 
million for fiscal year 2005 to maintain the ongoing national 
collaborative research to improve neuroimaging technologies for early 
detection and large-scale clinical trials to test the effectiveness of 
vitamins and other large-scale clinical trials for treatments that 
would slow or delay the progression of Alzheimer's.
    Research on Alzheimer's is on the brink of major breakthroughs that 
will provide the effective means to delay and, ultimately, to prevent 
the devastation of dementia.
    This effort will not be possible without your support, the 
Coalition of Hope, and the nationwide network of investigators working 
closely with the NIA's 29 Alzheimer's Disease Centers around the United 
States.
    That is a modest request, given the urgency of the Alzheimer crisis 
and the enormity of the scientific opportunities. But it would be 
enough to sustain the momentum in tough budget times.
    On behalf of the Alzheimer's Association and the entire Coalition 
of Hope, thank you.

    Senator DeWine. Thank you very much. Dr. Snowden.

STATEMENT OF DR. DAVID SNOWDEN, PROFESSOR IN THE 
            DEPARTMENT OF NEUROLOGY AND THE SANDERS-
            BROWN CENTER ON AGING AT THE UNIVERSITY OF 
            KENTUCKY, LEXINGTON, KY
ACCOMPANIED BY SISTER GENEVIEVE KUNKEL, NUN STUDY PARTICIPANT

    Dr. Snowden. Good morning. I am David Snowden, I am a 
Professor of Neurology from the Sanders-Brown Center on Aging 
at the University of Kentucky Medical Center. I'm also the 
Director of the Nun Study, a longitudinal study on aging and 
Alzheimer's disease. I am here not just to describe some of the 
important findings of our study but also to emphasize the 
importance of this type of research and to urge you to find 
some way to keep this and other critical research going 
forward.
    To understand how disease is caused and prevented, we 
usually follow a population of people over time and see who 
develops the disease and who doesn't. In 1990 funding from the 
National Institute on Aging allowed us to start a long-term 
study of older members of the School Sisters of Notre Dame 
Congregation. Three factors made this population of nuns a rich 
source of research data and biologic material. First, members 
of this community have a shared common environmental lifestyle 
from early adulthood, which holds many confounding factors 
constant. Second, each convent has an archive of information on 
each Sister, from the time she entered the congregation as a 
young woman until her death. The archives provide a unique 
window into the early and middle lives of the Sisters decades 
before any of them developed Alzheimer's disease. The third 
critical element is the courage and altruism of this inspired 
group of women, all of whom agreed to donate their brains at 
death for our studies.
    The 678 nuns agreed to give us complete access to their 
personal and medical records and participate in annual 
examinations of their mental and physical function. We have 
followed them meticulously since 1990 and to date almost 500 
brains have been donated, making it one of the world's largest 
neuropathologic studies. Participants in our study range in age 
from 75 to 107 years of age. Sister Genevieve Kunkel, from our 
Baltimore convent who is sitting with me today, is a stellar 
example from our study. She has avoided Alzheimer's and aged in 
a truly healthy and beautiful manner. Sister Genevieve 
describes healthy aging as being ``alert and vertical.'' And in 
her comments at the end of my presentation you'll witness the 
human potential available to all of us in a world without 
Alzheimer's disease.
    The Nun Study represents a long-term investment. Since 1990 
we have received $12 million of funding from the National 
Institute on Aging. Has the investment been worth it? You be 
the judge. We were the first study to show how a preventable 
disease like stroke can trigger the symptoms of dementia in 
persons with an Alzheimer's brain. We were one of the first 
studies to show that a deficiency in folic acid, a vitamin, 
accelerates the brain-damaging effects of Alzheimer's disease. 
We were the first study to show that Alzheimer's pathology and 
symptoms are predicted by low linguistic ability in 
autobiographies completed 60 years before. This suggests that 
Alzheimer's, like cancer and heart disease, is a lifelong 
disease process.
    This is only the beginning. We still have a great deal more 
to do and are accelerating our progress by sharing our unique 
research materials with other scientists. For example, if we 
secure funding scientists at several collaborating universities 
will use genetic material to create a complete genetic library 
for each nun. A non-human genome project, if you will, that 
will be linked to our treasury of information from the Sisters' 
medical and personal histories, annual medical exams and 
autopsy findings. Since we began the Nun Study, we have seen an 
explosion in medical and scientific technology which has opened 
up enormous opportunities for discover. The price tag for these 
sophisticated studies has skyrocketed. It's offset, however, by 
the knowledge gained that leads to new prevention strategies 
that can reduce human suffering and health care costs.
    I urge Congress to find some way to significantly increase 
research funding because a world without Alzheimer's is 
literally within our grasp.
    Now I would like to ask Sister Genevieve Kunkel, one of our 
participants in the Nun Study, to add some brief comments.
    Sister Genevieve Kunkel. Thank you. Let me begin by saying 
I pray daily for wisdom and prudence and this morning I prayed 
extra hard for these gifts. It has been privilege and pleasure 
to be an active participant for 14 years in Dr. Snowden's 
research. And there have been some personal perks, like an 
appearance with him and Katie Couric and a full chapter in his 
book, ``Aging With Grace.'' Not displeasing at all for one in 
her late 80s.
    It is rewarding to have frequent, friendly and informative 
reports from Dr. Snowden and his dedicated staff, assuring us 
Sisters that the donation of our brain is contributing 
significantly to this promising study of the dread disease of 
Alzheimer's. As a School Sister of Notre Dame for more than 72 
years, it is good for mind and spirit and body to know that I 
can still, even as a fully-retired Sister, continue to be a 
vital part of this ongoing project. My philosophy as a woman, a 
religious and a teacher, has always been to be grateful for the 
past, enthusiastic about the present and confident about the 
future. Dr. Snowden's cause is a good one. I'm grateful for it 
and enthusiastic about it.

                           PREPARED STATEMENT

    I was asked a second question. What is it like to watch 
those with whom you live afflicted with Alzheimer's? To phrase 
it bluntly it isn't easy. As a Sister, my faith that this is 
part of the Pascal mystery of Lent, reaching up or leading up 
to Easter and eternal life, eases the pain somewhat. May 1, I 
will celebrate the 70th anniversary of my professional vows, a 
commitment I made in 1934 with 55 other young women. It is 
saddening to watch my friends, my Sisters stricken with the 
diminishments of ailing and failing. And when these are 
accompanied by Alzheimer's it seems and is so much more 
devastating. How painful to see Sisters much younger than I 
enter this darkened world. How often I ask, why them? Why not 
me? Living with this reality daily has made me more prayerful 
about finding a cure and more zealous to remain actively 
involved in the Nun Study of Dr. Snowden.
    Thank you very much.
    [The statement follows:]

                Prepared Statement of Dr. David Snowden

    Good morning. I am Dr. David Snowdon and I am a Professor in the 
Department of Neurology and the Sanders-Brown Center on Aging at the 
University of Kentucky Medical Center. I am the director of the Nun 
Study, a longitudinal study of health and aging.
    I am delighted to be here with the School Sisters of Notre Dame--
not just to describe some of the important findings of our study, but 
also to emphasize how important this type of long-term research 
investigation is to solving the enigma of Alzheimer's disease, and to 
urge you to find some way to keep this critical work going forward--as 
fast as possible.
    Prevention depends upon understanding risk factors and how we can 
protect against them. To do that, we usually follow a population of 
people over a time and see who develops disease and who doesn't. After 
conducting a pilot study of Minnesota nuns in the 1980s, the staff of 
the National Institute on Aging encouraged us to submit a grant 
application to expand the Nun Study to all older School Sisters of 
Notre Dame throughout the United States, including those living in 
Minnesota, Wisconsin, Illinois, Missouri, Maryland, Connecticut, and 
Mississippi. The institute funded our study in 1990, and it has been 
ongoing ever since.
    Three factors made this religious population a rich source of 
research data and biologic material. First, this is a community whose 
members have had shared a common environment and lifestyle from early 
adulthood--which holds many confounding factors relatively constant. 
Second, each convent has an archive of information on each sister, from 
the time she entered the congregation as a young woman until her death. 
The archives provide a unique window into the early and middle lives of 
the sisters, decades before any of them developed Alzheimer's disease.
    The third critical element is the courage and altruism of this 
inspired group of women, all of whom agreed to donate their brains at 
death for our studies. This allowed us to investigate risk and 
protective factors by comparing the brain tissue of cognitively-intact 
sisters to those who had severe symptoms of Alzheimer's, and every 
shade of gray in between these extremes. The 678 nuns in our study 
agreed to give us complete access to their historic personal and 
medical records, and participate in annual examinations of the mental 
and physical function. We have followed them meticulously since 1991 
and to date almost 500 brains have been donated by these carefully 
studied women--making it one of the world's largest neuropathologic 
studies.
    Participants in our study range in age from 75 to 107 years old. 
Sister Genevieve Kunkel from our Baltimore convent, who is sitting with 
me today, is one of our stellar examples from the study. She has 
avoided Alzheimer's and aged in a truly healthy and beautiful manner. 
Sister Genevieve describes healthy aging as being ``alert and 
vertical''--in her comments at the end of my presentation you will 
witness the human potential available to all of us in a world without 
Alzheimer's.
    I would like to underscore that this has been an interdisciplinary 
effort at the University of Kentucky--involving social scientists, 
anthropologists, molecular biologists, pathologists, and physicians. As 
we have progressed to more sophisticated questions, we are increasingly 
engaging scientists from other research institutions and other 
scientific disciplines. To maximize the federal government's and the 
sisters' investment in this study, we are making our rich source of 
data and tissue available to researchers across the United States.
    The Nun Study represents a long-term investment by the Federal 
Government. Since 1990, we have received $12 million from the National 
Institute on Aging. Has the investment been worth it? You be the judge.
  --We were the first study to show how a preventable disease like 
        stroke can trigger the symptoms of dementia in a person with an 
        Alzheimer-brain.
  --We were one of the first studies to show that deficiency in the 
        vitamin Folic Acid appears to accelerate the brain-damaging 
        effect of Alzheimer's disease.
  --We were one of the first studies to show that Alzheimer's, like 
        cancer and heart disease, is a life-long disease process. While 
        it has been known for decades that low education is a risk 
        factor for Alzheimer's, it has not been know why--is it related 
        to early brain and cognitive development, a higher prevalence 
        of lifestyle risk factors, or reduced access to health care in 
        those with low education? Early cognitive development is likely 
        to be a primary explanation. Linguistic analyses of 
        autobiographies written by the nuns in early life indicates 
        that low verbal skills are a potent predictor of Alzheimer's 
        pathology in the brain and Alzheimer's symptoms 60 years after 
        the autobiographies were written.
    And this is only the beginning. We still have a great deal more to 
do.
    We continue to pursue other novel approaches to the study of 
Alzheimer's disease. For example, over 95 percent of people will 
develop the protein deposits, the so-called plaque and tangle lesions 
of Alzheimer's, if they live to be old enough. Yet most will somehow 
escape showing any significant symptoms of this disease. We and other 
scientists are trying to get a better understanding how such people 
avoid symptoms despite having the disease present in their brain.
    We are also carefully studying the small minority of participants 
who never show the development of any significant Alzheimer's lesions--
people who truly inhabiting a pristine world without Alzheimer's. Once 
we understand that, we'll be in a much better position to develop 
preventive interventions.
    If we can attain additional funding in the future, the long-term 
investment by the National Institute on Aging will provide even more 
added-value:
      i. For example, with nearly 500 brains in hand we are now working 
        with world-renowned experts in the study of blood vessel 
        diseases. This will allow us to get a better understanding of 
        how the health and disease status of microscopic, small, and 
        large blood vessels in the brain are related to Alzheimer's, 
        other dementias, overall health and function, and longevity. By 
        sharing brain tissue and data already collected on nearly 500 
        study participants with scientists at other U.S. research 
        institutes, our colleagues there will have the ability to 
        quickly and inexpensively perform new promising investigations 
        that would otherwise cost literally 10's of millions dollars 
        and take 10 to 20 years to complete. With only a couple 
        millions dollars of funding, we can have the answers within a 
        few years.
      ii. Working with scientists at the University of Kentucky, Johns 
        Hopkins University, and the University of Minnesota, we are now 
        pursuing a strategy to use the genetic material collected from 
        these nuns to ultimately create a genetic library for each of 
        the 678 study participants. That is, the complete genome of 
        each sister, all 30,000 plus genes, will ultimately be 
        described and available in a computer database. If this study 
        is funded, instead of going to the laboratory to study a single 
        gene, investigators will simply log onto to the Nun Study 
        Genetic Library to access the entire genetic structure of each 
        sister, as well as all the risk factor data, medical history, 
        and findings from the brain autopsy.
    Since we began the Nun Study, we have seen an explosion in medical 
and scientific technology and methods, which has opened up enormous new 
opportunities for discovery. When we began, in 1991, we asked the 
sisters to donate some blood for future studies. At the time, we 
envisioned looking at nutrients and other chemicals in the blood, and 
possibly a gene or two. Never would we have imagined that development 
of technologies like gene amplification and micro-array analysis would 
allow us to determine the entire genome of individual sisters; or that 
we would need sophisticated data storage and data analyses techniques 
to handle this mind-boggling amount of genetic information. All of 
these add value to what we started, but, they all cost money.
    The Nun Study is just one example of how the National Institute on 
Aging has capitalized on a long term funding strategy to provide a 
unique perspective on aging and Alzheimer's disease. Other 
investigators are pursuing unique populations, and there is much that 
remains to be done, especially in the study of dementia in specific 
racial and ethnic populations--an area of study that at best, we have 
only rudimentary understanding.
    We cannot put these studies off years and decades into the future. 
We need to conduct them now. There is still time to find answers and 
get interventions in place before the disease progresses further in the 
baby boomers, and subsequent generations. With only a minimal increase 
in National Institutes of Health funding this year, our research team 
and others across the United States will be stalled in our search for 
vital information about the prevention and treatment of this 
devastating disease. I urge Congress to find a way to make the 
commitment to finish the job it started. A world without Alzheimer's is 
within our grasp.

    Senator DeWine. Sister, thank you very much.
    Let me turn at this point to Senator Harkin. Before I do, 
let me just, if I could, make a comment, and that is that 
Senator Specter and Senator Harkin, as already been noted by 
several of our panelists, have certainly been the great leaders 
in this Congress and in this country for funding of 
Alzheimer's, as they have in other areas of health research. 
And it has been my privilege to serve with both of them here in 
Congress and just to watch this great leadership. So, Senator 
Harkin, your comments?

                    STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Well Mr. Chairman, thank you very much. I 
apologize for being somewhat late. I am also going to apologize 
for having to leave early. I have two cities from Iowa who are 
waiting for me over in the Russell Building right now, that is, 
the Chambers of Commerce and business leaders that I have to go 
meet with. You understand that, right Johnny? And so I will 
apologize for leaving a little bit early also.
    I just want to thank all of you for being here. You will 
excuse me if I pick on a couple of people. First, Shelley 
Fabares, who said she was first here in 1990, I remember it 
well, I was chairman at that time of this subcommittee, and 
came back repeatedly every year for the Alzheimer's 
Association. You know my thoughts and prayers were with you 
during your struggles in the 1990s when you had your own health 
problems but your husband continually assured me that you were 
a fighter and that you were going to get through it. And it is 
great to see you here and looking so well again, Shelley.
    Ms. Fabares. Thank you, Senator.
    Senator Harkin. It is great to have you back.
    Ms. Fabares. Thank you so much.
    Senator Harkin. And just again, thanks for never giving up 
in your own personal struggle but also in the struggle for 
continued increased funding for Alzheimer's. You have just been 
a real stalwart for the last, well, 16 years, I guess it is 
since I have known you.
    To Johnny and Romie Orr, again, thank you for being here. 
And for giving witness and testimony to what you have been 
through. I do not know if it was said, Mr. Chairman, but Johnny 
Orr is the winningest coach in Iowa State University history 
basketball. That is my alma mater so I follow that pretty 
closely. And you and Romie have been married how long? Fifty-
five years now, did you say? Fifty-five years. Good for you. 
And I know how much you have worked on this issue, we have 
talked about it in the past and it is just good to see you 
here. Romie, I know that you have been doing a lot of good 
things. Oh, by the way, I notice that your doctor is Dr. 
Bender. He is a great doctor. He treated my brother and got him 
through some years of some dementia problems also so I have 
great respect for him and for his ability. So you are living 
proof that he does pretty good stuff, right? Gives you good 
advice.

                      RESEARCH APPLICATION FUNDING

    To the rest of you who are here. Dr. Hodes, thank you for 
your leadership at the National Institute on Aging. I would 
like to just ask what the funding this year would mean for the 
Neuroimaging Initiative that you are doing in terms of how many 
applications, how many research applications can actually be 
funded compared to what we were doing in the past. If you could 
either answer it now or I can just submit that in writing and 
you can get it back to me because I want to know what this 
small increase in funding that we have this year, what that may 
mean. And if you have a succinct answer, if you could just 
respond to me on that. What are we looking at in terms of the 
reduced number, if there will be one, in funding for peer-
reviewed grant applications that would be involved with the 
Neuroimaging Initiative?
    Dr. Hodes. Well, if I may, sir, just to answer first 
generally for NIA and for the Alzheimer's research supported by 
NIA, whereas in prior years we were able to fund approximately 
25 percent or one-fourth of meritorious applications our best 
estimates at this point of the year is that we're funding 
approximately 15 percent. And in order to accomplish that we in 
fact have had to make very significant reductions in the amount 
of award to even achieve a raised pay line or a higher success 
rate for Research Project Grants (RPG).
    Senator Harkin. So 15 percent and with reduced awards.
    Dr. Hodes. This is correct.
    Senator Harkin. And in the past you have been as high as 
20?
    Dr. Hodes. Approximately 25 percent.
    Senator Harkin. 25 percent. I just want to note that for 
the record, Mr. Chairman, that even though we are giving a 
slight increase what it means is that we will be able to fund 
fewer grants, and I did not know about the reduced amount of 
the awards also.
    Dr. Hodes. I don't want to miss this or any opportunity to 
thank Congress for the support in the past or in the period 
they're doubling in particular. The success of this investment 
is, I think, manifest in the number of investigators who are 
now taking advantage of past research findings and 
opportunities and submitting meritorious applications. And a 
part of the challenge in funding an appropriate percentage is 
that the ingenuity, the opportunities, the genius of the 
scientific community has not slowed down even if the budget 
increase has.
    Senator Harkin. Very good. Again, Johnny and Mrs. Orr, 
thank you very much for being here. I am really proud of you 
and proud to represent you here in the U.S. Senate. These are 
two of our best known Iowans, of course, as I said, he coached 
Iowa State, and that's the premiere college in America, we know 
that. But actually, Romie is really the expert, right?
    Mr. Orr. I was at Michigan too, don't forget.
    Senator Harkin. I know but that was a long time ago.
    Mr. Orr. Senator Harkin, we've been involved in a lot of 
things in Iowa together.
    Senator Harkin. Yes.
    Mr. Orr. And he's always been very supportive and you know, 
I can't explain to you, I was worried about the time element, 
but until it hits you, or someone close to you, it's hard to 
explain it. It's really hard to explain it.
    Senator Harkin. Romie, I mean, I know you are under Dr. 
Bender's care but what are some of the things you are doing now 
to kind of forestall the impact of Alzheimer's?
    Mrs. Orr. I'm taking Aricept.
    Senator Harkin. Oh yes.
    Mrs. Orr. Which is a wonderful medication. I take one pill 
a day. And then I take a large range of vitamins, Gingko Biloba 
and Vitamin E and Vitamin C. And I take the vitamins twice a 
day and I take Zoloft at night.
    Senator Harkin. Yes.
    Mrs. Orr. And I'm getting along fine. I have a wonderful 
time. I'm a rug hooker. I hook rugs.
    Senator Harkin. Okay.
    Mr. Orr. Imagine me marrying a hooker? Been living with her 
for 55 years.
    Senator Harkin. She hooked you good.
    Mrs. Orr. My current project is a big tapestry of the 
harvester, up by Marshalltown.
    Senator Harkin. Yes, sure.
    Mrs. Orr. And I'm going to put, I just told my daughters 
today that I'm going to put the Alzheimer's signature right 
underneath my signature on this work of art; I call it a work 
of art. I was given the ability to copy it, for one copy.
    Senator Harkin. Well Romie, you are a former physical 
education instructor.
    Mrs. Orr. Right.
    Senator Harkin. So obviously you are in great physical 
shape. You said something about your doing mental things, too. 
Hooking rugs, obviously, but what else?
    Mrs. Orr. Well, that helps so, it really does because 
there's a bit of color planning and everything going all 
through that.
    Senator Harkin. I see.
    Mrs. Orr. The other thing I do is play solitaire. I play 
three games of two different solitaire every single day, no 
matter what.
    Senator Harkin. Oh, that is good.
    Mrs. Orr. It keeps me sharp. It takes a lot of time so I 
don't have to stay in the kitchen all day long.
    Mr. Orr. You have to be careful at our house, anymore, what 
you grab though, sometimes. She put the Cascade in the 
refrigerator the other day and that was a little difficult 
mixing that up, you know? But we've done great.
    Senator Harkin. That is good.
    Mr. Orr. And we've approached this thing as optimistically 
as you can possibly do it. And so have my daughters and 
hopefully we're going to whip this thing. And it's a terrible 
thing.
    Senator Harkin. Well, I would expect nothing less than the 
utmost optimism from Johnny Orr, I can tell you that, and Romie 
also, both of you. And thank you all again, very much. Shelley 
again, it is great to see you back and it is great to see you 
back in full health again. It is wonderful. And please give 
Mike my best.
    Ms. Fabares. I will. Thank you.
    Senator Harkin. Thank you all very much. Thank you, Mr. 
Chairman.
    Senator DeWine. Thank you very much. Dr. Snowden, tell us a 
little bit more about your study. What activities early in 
life, let us put this maybe in a practical, easy to understand 
for anybody who might be watching this or who might read about 
it, what activities would you recommend or things would you 
recommend for people early in their life? And then, what would 
you recommend for someone later in their life? Someone who is 
60, 70 years old, 80 years old. However later in life is. I 
mean, what did you learn, just tell us what you learned that 
would be helpful to people? Some of this is heredity, 
obviously, but some of it maybe can be influenced.
    Dr. Snowden. Well, Alzheimer's is obviously a thinking 
disease and it does make some sense that your development of 
thinking abilities in early life may play a role in buffering 
you against this thinking disease decades later, as well as 
maintaining your thinking ability throughout your middle and 
late ages. It's been known for probably 15, 20 years that 
education is strongly related to the risk of dementia; the 
lower the education, the higher the risk of Alzheimer's 
disease. And that's true whether you're in China, France, 
Africa, or in the United States. What it is about education in 
early life has been a little bit of a mystery. With the Sisters 
we have the benefit of having autobiographies that Sister 
Genevieve and others wrote when they were in their early 20s 
and teens. And so we have looked at the linguistic ability, or 
basically the number of ideas that they can pack into sentences 
60 years before they ever developed Alzheimer's disease, and we 
can see basically that those who had really good language 
ability could pack a lot of sentences--a lot of ideas into 
sentences. And 60 years later when we looked at their brain 
they had dramatically less Alzheimer's disease in their brain 
and they have a dramatically lower risk of Alzheimer's. So 
obviously language is extremely important, it's probably the 
key human skill that we have that we do our best work and our 
worst work through organizing groups through language. And 
language is probably the thing that really, when it starts to 
decline in Alzheimer's then you have all sorts of social 
problems and the patient being able to communicate with the 
family and the family communicating with the patient. So, 
simply promoting education, Head Start, probably during the 
first 5 to 6 years of life is really critical in developing 
language ability. And this is obviously a good thing anyway 
because we're all big advocates of education.
    During middle again, certainly----
    Senator DeWine. Which gives us one more reason to do what 
we should be doing anyway.
    Dr. Snowden. Absolutely, right, absolutely. So education is 
really, it's a critical, it's a, you know, major foundation for 
so many things and may have implications decades and decades 
later on your risk of Alzheimer's and health care costs. So 
certainly education is a key factor and particularly early-life 
education is important.
    During middle life it's important to maintain your 
cognitive abilities and that can be something as simple as 
buckling your seatbelt up because we know that head injury is 
also a risk factor for Alzheimer's disease. It's certainly 
something that's preventable and something that we should do 
for other very good reasons. And certainly trying to prevent 
other diseases to have affects on thinking ability like stroke 
is something one can do through middle and late age. It's 
always been an issue though, you know, does reading and doing 
the New York Times puzzles and so forth, crossword puzzles, 
will that have an effect on your risk of Alzheimer's. And 
that's been difficult because as people develop the disease 
obviously their thinking ability and their ability to do 
crossword puzzles decline. So it's hard to know which came 
first, the low ability in doing crosswords or reading or do the 
Alzheimer's symptoms come first. But because of the funding 
from the National Institute of Aging there have now been 
clinical trials that have been started and results are starting 
to come out suggesting that if you experimentally randomly 
assign thinking tasks to elderly people that that will help 
them maintain their thinking abilities and the suggested 
evidence is that this ultimately may lead to a lower risk of 
Alzheimer's.
    So I'd say the bottom line is that, you know, whether or 
not you get any disease, be it an infectious disease like HIV 
or a disease like cancer, heart disease or Alzheimer's, there's 
a consequence of a long chain of events and starting from 
conception with the genes to young age to middle age and late 
age, and so what we want to do as individuals and public is we 
want to focus in on the weak links in that chain that we can do 
something about. Certainly education, certainly prevention 
programs for head trauma, stroke prevention programs, 
nutritional programs also, I think, will have a potentially 
large effect if we can get more funding of nutritionally 
studies. Because Alzheimer's is a brain-wasting disease and it 
makes sense that the last thing you want to do when your brain 
is being wasted by Alzheimer's is nutritionally deprive it. So 
eating a lot of fruits and vegetables and for scientists to 
figure out what is it about specific components of diet, from 
Gingko to teas to vitamins that may help in slowing down the 
degeneration of the brain tissue.
    Senator DeWine. Did your study, and anybody else can jump 
in here, I am not going to just focus on Dr. Snowden's study, 
but anyone else who wants to jump in is fine, on the nutrition 
side, did your study indicate any, as far as the history of the 
nuns, maybe it was a more controlled group there, were you able 
to tell any difference in the nutrition there?
    Dr. Snowden. Well certainly our big finding in the 
nutrition area has been with the vitamin Folic Acid, that we 
could see as the higher of the blood level of the Folic Acid in 
the Sister that even when she had Alzheimer's disease in her 
brain that the higher the Folic Acid the less damage to the 
brain with Sisters who had an Alzheimer's brain. So Folic Acid 
is extremely important from conception on and obviously is 
critical to the development of the spinal cord and the brain 
during the fetal development. Certainly for the March of Dimes 
that's probably their poster child now is they're really trying 
to get pregnant women, or women who may get pregnant, to eat 
Folic more, to get more Folic Acid even before they know 
they're pregnant. So we know it's important in the development 
of the nervous system, the brain and the spinal cord. It 
shouldn't be too surprising to suggest that it also may be very 
important in the maintenance of the brain, particularly when 
it's under attack. But that's just one potential candidate. Dr. 
Hodes could tell us much more about the possibilities of new 
findings and new studies going on in nutrition. It's something 
we all can do.
    Senator DeWine. My wife was the nutritionist in the family. 
What does that translate for me, for the average person. What 
does that mean? What do you eat, what do you not eat? What does 
that translate to? What is the diet recommendation?
    Dr. Snowden. Well, the easiest way is a multi-vitamin pill.
    Senator DeWine. Okay, that is the cheap way, maybe not 
cheap, that is the easy way.
    Dr. Snowden. Because of a Federal lawsuit many years ago 
that Folic Acid was added to enriched wheat products that means 
that whether you're eating pretzels on the plane or enriched 
breads or breakfast cereals, the Folic Acid--this was designed 
to try to get Folic Acid in the food stream so that women, 
before they got pregnant or before they knew they were 
pregnant, were getting Folic Acid. And that's what's happened 
over the last several years is that the Folic Acid levels have 
risen dramatically in the United States. And if Folic Acid ends 
up being definitely shown to reduce the risk of Alzheimer's 
disease the Federal law that got Folic Acid into the food 
stream may end up being the really first classic health 
maneuver that was designed to reduce Alzheimer's disease 
without changing anybody's behavior.
    Dr. Hodes. I'd be happy to elaborate on that.
    Senator DeWine. Please, jump in, Doctor.
    Dr. Hodes. As Dr. Snowden has emphasized we've learned a 
lot from clinical and epidemiologic studies, and the Nun Study 
is an eminent one among those. But what we've learned are 
suggestions of factors which may correlate with risk of 
Alzheimer's disease and therefore which may be causally 
related. So as he points out, clues come from educational 
history or diet, and most importantly these clues then need to 
be translated into clinical studies that directly test the 
effects, along the lines of nutrition and the specific agents 
that have been mentioned already; there are studies in progress 
looking at the effects of Folate, B vitamins, antioxidants and 
their impact on Alzheimer's. And these are studies that are 
capable of providing the most definitive answers.
    The other general point that I would make in elaboration is 
that in addition to the important factors through the 
developmental lifespan of an individual from conception to 
birth and on, we've learned things in the past decade or so 
about changes which can occur in an adult, even in older 
adults, that really ran in the face of what had been dogma not 
so long ago so that Dr. Snowden and others in the field well 
understand. A decade of so ago it was well presumed that the 
brain cells one had as an adult were all one was ever going to 
have, there was no capacity to regenerate new brain cells. So 
when cells were lost they were lost forever without 
replacements. We've learned from animal studies and from humans 
that in fact the brain is capable, in critical areas, of 
generating new cells and intriguingly that in animal studies in 
particular it appears that the pace at which these new cells 
are generated can be influenced by activity, by physical 
activity and by intellectual or environmental challenge. So 
there is hope not only for interventions early in life, which 
we would all agree are the most effective for prevention, but 
also for interventions throughout the lifespan that are capable 
of modifying, preventing and, in principle, even reversing some 
of the neuronal loss or loss of function in brain cells that is 
the hallmark of Alzheimer's disease.
    Mr. Goldberg. Senator.
    Senator DeWine. Mr. Goldberg.
    Mr. Goldberg. We indicated that we started a Coalition to 
do this but part of this is also a concept called ``Maintain 
Your Brain'' and we'll be doing lots of advertising. And there 
are only indications, but strong indications, such things as 
high cholesterol levels, such things as diabetes, watching your 
sugar, such things as maintaining a good proper blood pressure, 
all have indications, as well as diet, all have indications 
that they may help to promote a healthier lifestyle, a better 
heart but also diminish the risks of Alzheimer's as well. And 
so that is a message we are going to try to convey to the 
American people as well, that these things can help, perhaps if 
not give you a better heart but we think have strong 
indications to help maintain the brain as well.
    Senator DeWine. That is basically one more reason to do all 
the right things, then.
    Mr. Goldberg. Just what our mothers told us.
    Senator DeWine. So, I guess one summary would be to also 
stay intellectually active. I assume that would have some 
positive impacts. Dr. Snowden, do we have any data on that? I 
mean, that is intuitively what you would think but is there any 
kind of data on that?
    Dr. Snowden. Yeah, well there are some clinical trials that 
have come out that suggest that experimentally getting older 
Americans to do mentally challenging activities seems to reduce 
the decline in mental function. But my understanding is that 
these studies really didn't have the capacity to enroll 
thousands of people in order to directly test whether that 
actually ended up reducing the risk of developing Alzheimer's. 
These studies ultimately will lead to that but it will take 
more and more years. I mean, basically the National Heart and 
Lung and Blood Institute, you know, in the 1960s and 1970s put 
literally billions of dollars into large-scale population 
studies in order to study things that we take for granted now, 
like blood pressure and cholesterol and diet and smoking. We 
need that kind of, you know, I know it's probably fantasy land 
but that's the kind of commitment we need, that we've committed 
billions into studying the heart, I think we need to commit 
billions into studying large human population studies, 
particularly clinical trials so we can figure out what to tell 
people. Because ultimately it's going to end up reducing 
dramatically health care costs and human suffering. The 
ultimate in all this is prevention. It's like people drowning 
in a river and somebody's physician's down there trying to pull 
people out of the river who are drowning and somebody comes up 
to him and says the bridge is broken upstream, and the 
physician says, I'm too busy here to fix the bridge. Well, we 
need to fix the bridge. That's where the future is, is in 
preventing these diseases. And in general a lot of things that 
appear to be good for the heart, for overall health are good 
for the brain. So a lot of the potential interventions really 
could reduce Alzheimer's but also reduce stroke, heart disease 
and potentially cancers as well. So there's a lot riding on 
this and you pay now or you pay huge amounts later in human 
suffering and health care costs.
    Senator DeWine. I want to get back to the question of the 
money. This subcommittee, frankly, when you testify in essence 
you are preaching to the choir. As you know, this subcommittee 
is very, very supportive, the chairman has been very, very 
supportive, as you know, Senator Harkin has, the rest of us 
have been. But I would like for you, any of you, to try to 
maybe put this in perspective as far as when we look at the 
next few years, and you have touched on this a little bit, but 
try to give us some idea so as we talk to our colleagues and as 
we talk to our constituents and we talk to the taxpayers, what 
we can tell them, what, in these tight budget times, what 
additional money, what we can expect it possibly can do. You do 
not have a crystal ball but what is the best case here? Give us 
the ammunition.
    Mr. Goldberg. Could I make two arguments? If you go to a 
Governor today in America he will tell you that the thing that 
is driving the State budgets, which are in trouble, is 
Medicaid. And the biggest reason people are in nursing homes in 
this country is Alzheimer's disease. Sixty-five percent of the 
people in nursing homes today carry a diagnosis of Alzheimer's 
disease. And what's facing you dramatically is the Medicare 
program. The Medicare program, a person with Alzheimer's 
disease, costs three times the amount as the same person at the 
same age go broke. And if you start looking at the what the 
baby boomers, the numbers that are going to retire in a few 
years, they will drive the Federal budget. And I happen to 
believe there will be such a crisis in the Federal budget that 
I think it will cause the Medicare program to go broke. I think 
that is the driver. There was a commercial a few years ago, I 
remember this, it says, you pay me now or you pay me later. I 
don't think we can afford the price later.
    Senator DeWine. Anybody else? Good. Very good. Dr. Hodes, 
you want to take this on a little bit?
    Dr. Hodes. Yes, thank you.
    Senator DeWine. You have already touched on this a little 
bit but just kind of give us the big, long-term view on this.

                             FUNDING IMPACT

    Dr. Hodes. Yes, to expand on what I'd said earlier, these 
past years through the wisdom and generosity of Congress and 
the American public have seen the kind of explosion and 
information about Alzheimer's that we've heard about today 
translated now into larger number of prevention and treatment 
trials than have ever been possible before. And we have now a 
research community with true genius that is energized with 
ideas for translating basic science and laboratory discovery 
into clinical trials and interventions. The momentum of the 
science in this field is reflected in the applications that we 
have before us for studies that span the spectrum of basic 
science through clinical application which we will, with 
whatever funds are made available, support to the best wisdom 
of peer review and our own priorities. However, it is also 
quite clearly true that the numbers of meritorious applications 
that cannot be funded under this present year's budget is 
something far in excess of what we've seen before. What does 
this mean beyond numbers? What does it translate into? It means 
that we will have fewer opportunities to carry out the basic 
science to understand the molecular underpinnings of disease 
which are the basis for understanding future interventions. It 
means more immediately that we will have to make difficult 
choices about which promising interventions we attempt. We will 
not be able to carry out as many studies as rapidly as 
possible, which in the end, predictably, will have the effect 
of delaying ultimately what we all feel confident will be the 
cure. So the more restrained we are in budget now, even with 
our best exercise of judgement, predictably the more time it 
will take to make the progress necessary to finally address the 
problem and eradicate it.
    Senator DeWine. Very good. Well, we just appreciate your 
testimony, all of you, very much. It has been very, very 
helpful. It has really put a human face on this very, very 
tough disease and we appreciate all of you taking your time to 
travel here and to testify. And on behalf of all the 
subcommittee we really, really appreciate it. We are going to 
continue our commitment, I think you know this subcommittee is 
behind you and behind these efforts. So we are going to 
continue to work with you and look forward to continuing our 
efforts together. Thank you very much.

                ADDITIONAL SUBMITTED PREPARED STATEMENTS

    We have received the prepared statements of Senator Mary L. 
Landrieu and Phyllis Campbell, president, Urban League of 
Lancaster County, PA. They will be placed in the hearing 
record.
    [The statements follow:]

             Prepared Statement of Senator Mary L. Landrieu

    Thank you, Mr. Chairman.
    The subject of today's hearing is one that deserves our utmost 
attention. It is estimated that today, 4.5 million Americans have 
Alzheimer's Disease (AD). As the average life expectancy continues to 
increase, and the baby boomer population, as much as some of us may 
like to deny it, are beginning to age, the number of people affected 
with AD will skyrocket. If the current trend of AD continues, it is 
expected that by 2050, between 12 million and 16 million people will 
suffer with AD. Something must be done to prevent these estimates from 
becoming fact.
    Much advancement has been made in the field of AD research. 
Scientists have discovered many of the common characteristics of 
patients with AD: it is clear that age is a factor; scientists have 
noted the large deposits of beta-amyloid that occur during the process 
of AD; having large amounts of homocysteine can almost double one's 
chances of having AD, as research has shown. These advancements are 
great and have allowed scientists to find drugs that can help slow down 
the effects of AD, however, there is still no known cure. The fact of 
the matter is that today, if you are diagnosed with AD, you will have 
AD for the rest of your life, and it is highly probable that AD will 
cause your death.
    It is clear that more research is needed to find a cure for AD, but 
we as the keepers of the purse strings for federal medical funding, we 
are not allowing this research to take place. In the fiscal year 2004 
appropriations bill, the boost in funding for Alzheimer research at the 
National Institutes of Health (NIH) was only 3.7 percent, compared to 
the 15 and 16 percent increases that we have given NIH during the five 
years prior. Similarly, the funding for the Alzheimer Disease 
Demonstration Grant Program was cut by $1.5 million in fiscal year 
2004. And it appears that these trends of lowered funding are not 
stopping. In the President's fiscal year 2005 Budget Request, the 
funding level for Alzheimer research at NIH was increased by only 2.7 
percent.
    As the federal deficit continues to balloon out of control, we must 
be wise in how we spend our money. One practical way to prudently spend 
our money is to fund projects and research that will save us money in 
the future. Funding Alzheimer research is a prime example of this. If 
scientists can discover a cure for AD, we would literally save billions 
in the next few years. It is estimated that if the number of people 
affected by AD continues to increase as expected, the cost of AD on 
Medicare will increase from $31.9 billion in 2000 to $49.3 billion 
(over 50 percent) by 2010, while the cost of AD on Medicaid will 
increase by 80 percent (from $18.2 billion to $33 billion) over that 
same period of time. Moreover, government is not the only entity 
getting hit with this heavy bill. Today, seven out of ten people 
affected with AD live at home with 75 percent of their care being 
family and friends. This causes AD to cost American businesses over $60 
billion every year, over half of which is costs relating to caregivers 
of AD, loss in productivity, absenteeism, and worker replacement. By 
actually increasing funding for research to find a cure for AD, we can 
prevent these extreme costs from occurring.
    AD affects millions of Americans: one out of every ten Americans 
has a family member who is stricken with this fatal disease, and one 
out of every three Americans knows someone with it. We are on the brink 
of being able to reverse the current rising trends of AD, but in order 
to do this we must provide scientists and researchers with the funds 
they need. Thank you.
                                 ______
                                 
  Prepared Statement of Phyllis Campbell, President, Urban League of 
                     Lancaster County, Pennsylvania

    Good morning, Senators. Thank you for inviting me here today. I am 
honored--and a bit overwhelmed--to sit here with people who are 
devoting their lives to the fight against Alzheimer's disease. And I 
want to pay a special tribute to Coach and Mrs. Orr for their courage 
in sharing their very personal story.
    Let me make clear at the outset that I am not an expert on 
Alzheimer's disease. I have friends and acquaintances who are 
struggling with this awful disease, and I see the horrible toll it is 
taking on them. I consider myself fortunate that my family does not 
have first hand experience with this disease.
    So, why I am testifying. I am here as the President of the 
Lancaster County Urban League. We are one of more than 150 
organizations, representing over 53 million people, that have joined 
the Alzheimer's Association in a Coalition of Hope, to bring more 
attention and resources to the fight against Alzheimer's disease.
    As you know, the African-American community faces many public 
health crises--from infant mortality, to AIDS, to heart disease and 
diabetes. While our attention was otherwise focused, Alzheimer's 
disease has invaded our community and stolen from us some of our 
richest resources--our grandparents, our parents, our spouses.
    Alzheimer's has become a silent epidemic among African-Americans. 
But we can be silent no longer. That is why we, like many other Urban 
Leagues around the country, have joined the Coalition of Hope.
    There are at least five compelling reasons why African-Americans 
must join the fight against Alzheimer's.
    First, we are getting older--and age is a key risk factor for 
Alzheimer's. By the middle of the century, there will be four times as 
many African-Americans aged 65 and over than there are today (11 
million compared with 2.8 million in 2000). And there will be six times 
as many of us aged 85 and over (over 2 million compared with 300,000 
today)--when we will be most at risk for Alzheimer's. If we come down 
with Alzheimer's at the same rate everyone else does, more than 5 
million African-American babyboomers will get Alzheimer's disease.
    Second, there is evidence we may be at greater risk than others. 
I'm told that three out of four studies that have looked at Alzheimer's 
in our community show rates of dementia ranging from 14 percent to 100 
percent higher than in white Americans. We need to figure out why this 
is happening, and what we can do about it.
    Third, there is growing and alarming evidence that Alzheimer's may 
be linked to vascular disease, which is rampant in our community. I've 
heard about the study that shows people with high blood pressure are 
twice as likely to get Alzheimer's. That frightens me, because 65 
percent percent of African-American elders have hypertension (compared 
with 51 percent of white elders.) And African-Americans have a 60 
percent higher risk of type 2 diabetes--a condition that contributes 
directly to vascular disease.
    Fourth, dementia among African-Americans is seriously unreported. 
We tend to be diagnosed at later stages of Alzheimer's, even though 
everything I've heard is that treatment works best when it is started 
early in the disease. We must get our community to recognize the early 
signs of dementia, to understand that this is not just normal aging, 
and to seek evaluation and treatment.
    Fifth, we must make sure that potential treatments for Alzheimer's 
will work for African-Americans. There is growing evidence that the 
genetics of Alzheimer's may be different in African-Americans, and that 
our response to drug treatments may vary. NIA must have the resources 
it needs to identify all of the genetic risk factors for Alzheimer's 
disease, and to speed up the clinical trials of promising drug 
therapies. And we must make sure there is enough money in those studies 
to involve sufficient numbers of African-Americans in order to draw 
valid and specific conclusions for our community.
    That is why I am here today, on behalf of the Lancaster County 
Urban League and all of the members of the Coalition of Hope--to urge 
you to provide sufficient funds for NIA and NIH to complete its work on 
Alzheimer's disease. So that Alzheimer's will become nothing more than 
a memory, not just for African-Americans but for all of us.
    Thank you.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator DeWine. There will be some additional questions 
which will be submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

            Questions Submitted by Senator Mary L. Landrieu

    Question. Some critics of increasing funding for research have 
argued that the increases NIH received for Alzheimer research prior to 
last fiscal year flooded NIH, and thus increases of that size are no 
longer necessary. Will the decrease in the rate of increase of funding 
impede Alzheimer research at NIH? If so, what will you not be able to 
do now?
    Answer. A decrease in funding at this time would mean the National 
Institute on Aging (NIA) could not award grants to Alzheimer's disease 
(AD) research projects at levels recommended by the scientific peer 
review process. The NIA pay line for AD research will only reach to 
around 16 percent in fiscal year 2004, compared to 25 percent in fiscal 
year 2003. This means that only 1 out of 6 peer-reviewed studies is 
able to be funded. To reach even this level, new awards have had to be 
cut by an average of 18 percent, with the result that applicants have 
had to remove some of their aims, or in the case of large grants, some 
whole projects have been eliminated. The surge in Alzheimer's disease 
(AD) research initiatives and grant applications generated by the 
generous doubling of NIH budget between fiscal year 1999 and fiscal 
year 2003 continues at a volume that far exceeds current or projected 
funding. In fiscal year 2004, the NIA received many more grant 
applications than anticipated (approximately 40 percent more 
applications in fiscal year 2004 than received in fiscal year 2003), 
and at the same time, average grant costs have risen.
    The budget doubling of past fiscal years has also fast-tracked NIA 
AD clinical trials and made possible some exciting and innovative 
research collaborations. Continued funding at adequate levels will be 
needed to maintain and promote these scientific endeavors. NIA supports 
approximately 25 AD clinical trials, including large-scale prevention 
trials, which are testing agents such as anti-inflammatory drugs, 
statins, homocysteine-lowering vitamins, and anti-oxidants for their 
effects on slowing progress of the disease, delaying the onset of AD, 
or preventing the disease altogether. The price of conducting these AD 
prevention trials has increased and cost from $6 to $8 million per 
trial annually to enroll the needed number of subjects (as many as 
2,000 for some studies) and to evaluate treatment effects. Finding a 
biological way to accurately track AD development and progression is 
one of the objectives of the $60 million, 5-year NIA Neuroimaging 
Initiative (ADNI). This is a large-scale public-private partnership 
among NIA/NIH, academic investigators, the pharmaceutical and imaging 
equipment industries through the Foundation for the NIH, the Food and 
Drug Administration, and with participation from the Alzheimer's 
Association. This initiative is slated to begin in October 2004 with 
patient recruitment in April 2005. At current funding levels, only MRI 
and PET, but not other imaging modalities, will be evaluated in the 
ADNI for utility as surrogate markers in AD. These other modalities 
could include, for example, magnetic resonance spectroscopy (MRS) to 
measure certain neurochemical compounds, functional MRI (fMRI) to 
measure brain function in response to certain stimuli, and diffusion 
tensor imaging (DTI) to measure the fiber pathways that connect 
different parts of the brain.
    Question. A large amount of progress in finding a cure for 
Alzheimer's Disease has been made in recent history, and it appears 
that we are on the brink of finding a cure. Pretending that money is an 
unlimited resource, how much money do you estimate it would take to 
find a cure for AD?
    Answer. It is difficult to predict the pace or certainty of 
scientific discovery or to estimate the funding needed to find a cure. 
However, it can be said a significant increase in funding for 
Alzheimer's disease research would allow for new and expanded efforts 
in basic, translational and clinical research, while capitalizing on 
the many new initiatives and findings that were made possible during 
the years of the NIH doubling, including the entry of new investigators 
into this challenging field of AD research.
    Recent advances in Alzheimer's disease research, coupled with new 
and improved technologies in areas such as imaging, as well as the 
ever-expanding knowledge and tools available in the field of genetics, 
are creating new opportunities to make advances in preventing, 
treating, slowing the progression and possibly curing Alzheimer's 
disease. Researchers continue to make new basic research discoveries 
about the death of neurons and loss of their connections, and how to 
prevent this; pathways leading to plaque and tangle formation, and how 
to remove them, including promising vaccine therapy; protein 
aggregation and how to dissolve the aggregates; and underlying causes 
of memory loss and how to prevent this. In the area of translational 
research, better animal models of AD for testing possible therapies are 
being developed and many studies are being conducted on possible ways 
of preventing amyloid and tangle accumulation. Pre-clinical drug 
research and AD Prevention trials are providing us with some 
information which will be crucial to understanding how to prevent or 
delay the onset of Alzheimer's.

                         CONCLUSION OF HEARING

    Senator DeWine. Thank you all very much for being here. 
That concludes our hearing.
    [Whereupon, at 10:30 a.m., Thursday, March 23, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

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