[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]


 
                    GLOBAL STRATEGIES TO COMBAT THE
     DEVASTATING HEALTH AND ECONOMIC IMPACTS OF ALZHEIMER'S DISEASE

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

                                HEARING

                               BEFORE THE

                 SUBCOMMITTEE ON AFRICA, GLOBAL HEALTH,
                            AND HUMAN RIGHTS

                                 OF THE

                      COMMITTEE ON FOREIGN AFFAIRS
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 23, 2011

                               __________

                           Serial No. 112-96

                               __________

        Printed for the use of the Committee on Foreign Affairs


 Available via the World Wide Web: http://www.foreignaffairs.house.gov/

                                 ______



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                      COMMITTEE ON FOREIGN AFFAIRS

                 ILEANA ROS-LEHTINEN, Florida, Chairman
CHRISTOPHER H. SMITH, New Jersey     HOWARD L. BERMAN, California
DAN BURTON, Indiana                  GARY L. ACKERMAN, New York
ELTON GALLEGLY, California           ENI F.H. FALEOMAVAEGA, American 
DANA ROHRABACHER, California             Samoa
DONALD A. MANZULLO, Illinois         DONALD M. PAYNE, New Jersey
EDWARD R. ROYCE, California          BRAD SHERMAN, California
STEVE CHABOT, Ohio                   ELIOT L. ENGEL, New York
RON PAUL, Texas                      GREGORY W. MEEKS, New York
MIKE PENCE, Indiana                  RUSS CARNAHAN, Missouri
JOE WILSON, South Carolina           ALBIO SIRES, New Jersey
CONNIE MACK, Florida                 GERALD E. CONNOLLY, Virginia
JEFF FORTENBERRY, Nebraska           THEODORE E. DEUTCH, Florida
MICHAEL T. McCAUL, Texas             DENNIS CARDOZA, California
TED POE, Texas                       BEN CHANDLER, Kentucky
GUS M. BILIRAKIS, Florida            BRIAN HIGGINS, New York
JEAN SCHMIDT, Ohio                   ALLYSON SCHWARTZ, Pennsylvania
BILL JOHNSON, Ohio                   CHRISTOPHER S. MURPHY, Connecticut
DAVID RIVERA, Florida                FREDERICA WILSON, Florida
MIKE KELLY, Pennsylvania             KAREN BASS, California
TIM GRIFFIN, Arkansas                WILLIAM KEATING, Massachusetts
TOM MARINO, Pennsylvania             DAVID CICILLINE, Rhode Island
JEFF DUNCAN, South Carolina
ANN MARIE BUERKLE, New York
RENEE ELLMERS, North Carolina
VACANT
                   Yleem D.S. Poblete, Staff Director
             Richard J. Kessler, Democratic Staff Director
                                 ------                                

        Subcommittee on Africa, Global Health, and Human Rights

               CHRISTOPHER H. SMITH, New Jersey, Chairman
JEFF FORTENBERRY, Nebraska           DONALD M. PAYNE, New Jersey
TIM GRIFFIN, Arkansas                KAREN BASS, California
TOM MARINO, Pennsylvania             RUSS CARNAHAN, Missouri
ANN MARIE BUERKLE, New York


                            C O N T E N T S

                              ----------                              
                                                                   Page

                               WITNESSES

Richard Hodes, M.D., director, National Institute on Aging, 
  National Institutes of Health..................................     7
Daisy Acosta, M.D., chair of the executive board, Alzheimer's 
  Disease International..........................................    23
Mr. Eric Hall, president and chief executive officer, Alzheimer's 
  Foundation of America..........................................    28
Bill Thies, Ph.D., chief medical and scientific officer, 
  Alzheimer's Association........................................    33
Mr. George Vradenburg, founder, USAgainstAlzheimer's.............    40
Giovanni Frisoni, M.D. (via teleconference), deputy scientific 
  director, IRCCS-FBF Alzheimer's Center.........................    46
Jeffrey Cummings, M.D., director, Cleveland Clinic Lou Ruvo 
  Center for Brain Health........................................    50
Hugh Hendrie, M.D., professor, Indiana University................    57

          LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING

Richard Hodes, M.D.: Prepared statement..........................    10
Daisy Acosta, M.D.: Prepared statement...........................    26
Mr. Eric Hall: Prepared statement................................    30
Bill Thies, Ph.D.: Prepared statement............................    35
Mr. George Vradenburg: Prepared statement........................    42
Giovanni Frisoni, M.D.: Prepared statement.......................    48
Jeffrey Cummings, M.D.: Prepared statement.......................    53
Hugh Hendrie, M.D.: Prepared statement...........................    61

                                APPENDIX

Hearing notice...................................................    76
Hearing minutes..................................................    77
The Honorable Russ Carnahan, a Representative in Congress from 
  the State of Missouri: Prepared statement......................    78
The Honorable Christopher H. Smith, a Representative in Congress 
  from the State of New Jersey, and chairman, Subcommittee on 
  Africa, Global Health, and Human Rights: Material submitted for 
  the record.....................................................    79


GLOBAL STRATEGIES TO COMBAT THE DEVASTATING HEALTH AND ECONOMIC IMPACTS 
                         OF ALZHEIMER'S DISEASE

                              ----------                              


                        THURSDAY, JUNE 23, 2011

              House of Representatives,    
         Subcommittee on Africa, Global Health,    
                                   and Human Rights
                              Committee on Foreign Affairs,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:10 p.m., in 
room 2200, Rayburn House Office Building, Hon. Christopher H. 
Smith (chairman of the subcommittee) presiding.
    Mr. Smith. The subcommittee will come to order. I want to 
apologize for the lateness in starting. We are just completing 
a vote. But I do thank you all for being here and for joining 
us at this first ever congressional hearing examining the 
global strategies to combat the devastating health and economic 
impacts of Alzheimer's disease. This is the first in what will 
be a series of hearings. And hopefully over the course of the 
next 1\1/2\ years, this will be an opportunity to really 
refocus congressional efforts on the fact that this is not just 
a domestic problem, but also an international one that needs 
additional congressional engagement.
    Alzheimer's disease is the most common form of dementia, 
and it is a degenerative, irreversible, and terminal disease. 
Alzheimer's disease is most prevalent in people over 65 years 
of age, but early-onset Alzheimer's can occur at a much younger 
age, as we all know, even decades earlier. Alzheimer's 
progressively destroys remembering, thinking and reasoning 
skills, and eventually even the ability to carry out the 
simplest of tasks.
    While the cause and progression of Alzheimer's disease are 
not well understood, research indicates that the disease is 
associated with plaques and tangles in the brain that begin to 
develop 10 to 20 years before any problems are evident. As 
plaques and tangles form, neurons lose their ability to 
function, and eventually die. As more neurons expire, affected 
brain regions begin to contract. In the final stages of 
Alzheimer's, there is widespread damage and tissue shortage.
    Current treatments provide modest symptomatic benefits, but 
there are no therapies available that can halt or even delay 
the progress of the disease. The effects and duration of the 
disease vary from patient to patient, but it is invariably 
fatal.
    According to the Alzheimer's Disease International there 
were some 35.6 million people living with Alzheimer's and other 
dementias in 2010, and the number of people living with 
dementia is expected to nearly double every 20 years to 65.7 
million in 2030, to 115.4 million in 2050. However, the 
increase is greater for low and middle income countries, as 
some 57 percent of all people with dementia are currently 
living in low and middle income countries. And that will rise 
to 63.4 percent in 2030, and a whopping 70 percent in 2050.
    Here in the United States, up to 5.4 million people have 
Alzheimer's disease, and the number is expected to increase to 
up to 16 million by 2050 unless something is done to reverse 
the trajectory. The elderly population as a whole is growing, 
but the oldest elderly are the fastest growing age bracket.
    According to Alzheimer's Disease International, the total 
worldwide estimated cost of dementia is $604 billion, with 89 
percent of the costs occurring in high income countries and 
about 70 percent of those costs occurring in just two regions, 
Western Europe and North America. In low and middle income 
countries, the costs of informal care, in other words unpaid 
care provided by families and others, accounts for some 64 
percent of all care, while in high income countries the 
informal care accounts for 40 percent of the costs.
    Even in countries that have high health care expenditures 
and that provide government-funded support for long-term care, 
a vast amount of that care occurs informally within families. 
Not only will the increase in the population with Alzheimer's 
and other dementias result in skyrocketing costs of health 
care, but changing family dynamics will further exacerbate the 
economic stress on families, societies, and governments.
    As an example, on Monday of this week I chaired a hearing 
of the Commission on Security and Cooperation in Europe, also 
known as the U.S. Helsinki Commission, on the implications of 
demographic trends in the OSCE region, and we looked at some 
other parts of the world as well. Dr. Richard Jackson, Director 
of Global Aging Initiative at the Center for Strategic and 
International Studies, testified in that hearing that in 
certain European countries by 2020 the extended family will 
essentially be nonexistent. Half of young adults don't have any 
brothers or sisters or uncles or aunts or cousins. Another 
projection during the same hearing was that Japan could 
potentially experience an explosion of Alzheimer's prevalence 
of up to 1 in 25 as a result of the aging of the population, 
coupled with some 40 percent of the Japanese being childless. 
So the number of caregivers available will rapidly decline in 
Japan and elsewhere.
    When we look more closely at projected demographics for 
some countries, the pool of family caregivers is shrinking as 
the number of individuals with Alzheimer's is correspondingly 
exploding, which will significantly shift the costs of care 
away from unpaid, informal care to institutional and direct 
medical care.
    Poor recognition, under-diagnosis, and lack of public 
awareness are all causes of significant problems for afflicted 
individuals and their caregivers, especially in low and middle 
income countries.
    In those developing countries, it is often incorrectly 
assumed that dementia, such as Alzheimer's, is a normal part of 
aging and that nothing can be done to address it. Because of 
lack of recognition of the nature of the problem, there is a 
lack of pressure on government bodies to respond to the crisis. 
As a result, there is a lack of effort to devote resources 
toward finding a cure to help those with Alzheimer's by 
providing assistance or seeking a diagnosis and caring for 
those potentially afflicted.
    International cooperation and collaboration to find 
solutions for Alzheimer's is not new, as clearly demonstrated 
by the fact that the Alzheimer's Disease International began in 
1984, 27 years ago, with four members, and has grown now 
through the years to over 75 members. Similarly, I look forward 
to receiving testimony outlining past, present, and future 
international research collaborations.
    However, we do seem to be at a precipice now of making 
great strides on several different fronts. First, there is the 
greater recognition, including in low and middle income 
countries, of the need to address Alzheimer's as a major public 
health crisis. I agree with you, those who will testify, that 
we need to pressure international institutions responsible for 
health issues to recognize dementia as a global health problem. 
That is why Congressman Markey and I, and we do cochair the 
Alzheimer's Caucus here in the House, and we have done so for 
over a decade, we have coordinated a letter signed by 28 
Members of Congress to the U.N. General Assembly President 
Deiss to include Alzheimer's disease in the September U.N. 
Summit on Noncommunicable Diseases. Involvement of 
international organizations such as the United Nations and WHO 
are necessary to make substantial inroads toward raising 
awareness of dementia and beginning to address it in national 
health care policies and action plans. I plan on sending 
today's hearing record to all relevant U.N. officials, PAHO 
officials, and officials in the EU, and especially to heads of 
country delegations at the United Nations.
    Second, there is a significant momentum toward broader 
sharing and an increasing number of proposals for major 
intergovernmental research projects that will take advantage of 
emerging research opportunities and new computing platforms and 
communications technologies. Also, in response to two of our 
witnesses, Eric Hall and George Vradenburg, who made 
recommendations in their testimony for a government-sponsored 
international conference, I will soon introduce legislation to 
convene in the first quarter of calendar year 2012, or at a 
date thought to be more appropriate, an international 
conference to include at a minimum countries that have or are 
in the process of developing national Alzheimer's plans.
    Third, it is significant that the NIH funded the first 
intensive caregiver support intervention proven to be 
effective, through rigorous testing, in an ethnically diverse 
population, and that they are beginning to export the program. 
I do look forward to Dr. Hodes' testimony on this and other 
outstanding initiatives that he is leading at the NIA.
    Finally, since 2005, several countries have developed 
national Alzheimer's plans or strategies, which have already 
begun to accelerate changes in health care systems. I was 
honored to have introduced with Congressman Markey legislation 
to create a national strategic Alzheimer's plan for the United 
States. The National Alzheimer's Project Act, or S. 3036, which 
was passed first by the Senate and then by the House and signed 
in December by the President--or in January I should say, 
January 4th; it was a large, huge legislative victory for the 
cause of Alzheimer's here in the United States. The National 
Alzheimer's Project Act, NAPA, is designed to help turn the 
tide by creating a national strategic plan to address the 
rapidly growing crisis of Alzheimer's disease. NAPA provides 
for the coordination of all Alzheimer's disease efforts across 
the Federal Government. It also establishes an advisory council 
on Alzheimer's research, care, and services that would allow 
participation by patient advocates, health care providers, 
researchers, and State health departments in the evaluation of 
Federal Alzheimer's plans and the formulation of a strategic 
plan to reduce costs and improve health services. Recognizing 
the importance of international collaboration, the law requires 
coordination with international bodies to make the United 
States Government a committed partner in the global fight 
against Alzheimer's.
    Like many of you, I will be following closely the 
implementation of NAPA. And if Dr. Hodes would like to share 
any information on HHS activities on implementing NAPA, we 
would certainly appreciate any insights he could provide.
    While the national Alzheimer's strategic plan is being 
developed, Congressman Markey and I have also introduced 
additional legislation designed to bolster programs for 
Alzheimer's research and diagnosis.
    In May, we introduced the Alzheimer's Breakthrough Act, 
H.R. 1897, designed to accelerate treatments that prevent, 
cure, hopefully, or slow the progression of Alzheimer's disease 
and reduce the financial burden of Alzheimer's on federally 
funded programs and families. The Director of NIH will develop 
a strategic research plan, including budget estimates, for 
Alzheimer's disease, focused on targeting scientific 
opportunities and priorities, developing public-private 
partnerships, and improving coordination of Alzheimer's disease 
research across 27 institutes and centers at the NIH.
    Instead of prescribing a funding level for Alzheimer's 
research at NIH, as we attempted to do in previous bills, which 
sadly did not pass, this bill requires the experts at NIH to 
tell Congress and the administration what Alzheimer's research 
is needed to develop treatment breakthroughs and what level of 
funding is needed to accomplish that goal.
    In addition, I have joined Congressman Markey in 
introducing H.R. 1386, the Health Outcomes, Planning and 
Education for Alzheimer's Act, or HOPE, which will provide 
Medicare coverage for a comprehensive diagnosis of Alzheimer's 
disease and help improve care and reduce costs by providing 
information and resources to newly diagnosed patients and their 
families.
    I am very pleased to now yield to my good friend and 
colleague Mr. Payne, fellow New Jerseyan, for any comments he 
might have.
    Mr. Payne. Thank you very much. And let me commend my 
colleague, Chairman Smith, for calling this very important 
hearing: Global Strategies to Combat the Devastating Health and 
Economic Impact of Alzheimer's Disease. You, Mr. Chairman, 
along with Congressman Markey, Congresswoman Waters, and 
others, have been important drivers on this issue of 
Alzheimer's and other forms of dementia.
    I would also like to thank our witnesses. I look forward to 
hearing each of you and your testimonies on how Congress can 
best tackle Alzheimer's globally, specifically in Africa and 
developing nations that lack infrastructure to provide basic 
needs or are engaged in conflicts that displace large portions 
of their population and whose health care centers are 
overwhelmed with those suffering from HIV/AIDS, malaria, 
tuberculosis, and neglected tropical diseases.
    Alzheimer's disease, or AD, is the most common form of 
dementia. Symptoms include difficulty with speech, memory loss, 
depression or anxiety, and a decrease in mental ability. The 
disease often begins to show signs after the age of 65, and its 
likelihood of onset and severity increases as one ages. There 
is no cure, and symptoms are irreversible.
    According to Alzheimer's Disease International's 2009 World 
Alzheimer's Report in 2010, there were an estimated 35.6 
million people suffering from dementia. This same report cites 
that 58 percent of these people lived in low and middle income 
countries. It is projected that in 2050 the total number of 
those with dementia will be close to 110 million, with 71 
percent in those low and middle income countries.
    This growth, however, is likely to be less dramatic in sub-
Saharan Africa, where life expectancy is below that of the 
usual age of onset. There may be additional reasons for a lower 
prevalence of dementia in developing countries outside of lower 
life expectancy. Part of this may simply be diagnosis. There is 
no set approach or test to diagnose Alzheimer's, as we all 
know, nor can the disease be labeled conclusively until 
postmortem. Given that mild dementia can be subtle and a strain 
on health care centers in these countries due to diseases such 
as HIV and others, as I mentioned, it is often severe. It is 
reasonable to assume that in many of these countries this is 
being overlooked, and therefore, as we would know, 
underreported.
    I am interested to hear the panel's thoughts on these 
issues, as well as the potential causes of Alzheimer's. It is 
thought by many that genetics play a role. However, 
environmental factors may also contribute. In New Jersey, we 
have had a tremendous increase in Alzheimer's, in a State that 
has had environmental problems throughout the years, and we 
feel that that may be one of the possible causes. However, 
there is no conclusive evidence to that fact. These include 
high blood pressure, cholesterol, illiteracy, lower education 
levels, and stress.
    I am also interested in learning how these factors are 
being taken into consideration when both diagnosing and 
treating Alzheimer's. Additionally, I would like to know how 
these factors are taken into account when looking at 
Alzheimer's from a global perspective.
    Though a cure does not yet exist, both drugs and nondrug 
treatments are available for sufferers here in the United 
States and other developed countries. I hope to learn from our 
witnesses today about the best practices in combating 
Alzheimer's and how these practices can be applied to 
developing nations.
    I also hope to hear how those with Alzheimer's and other 
forms of dementia are being treated in conflict zones. Disabled 
people are often faced with increased challenges when displaced 
due to violence, and I am interested in learning about specific 
challenges Alzheimer's sufferers face in these crisis 
situations.
    Again, I look forward to the testimony of our witnesses, 
and I yield back the remainder of my time.
    Mr. Smith. Thank you, Don. I would like to now yield to a 
good friend and colleague, Ed Markey, who is the cochair of the 
Alzheimer's Caucus, and has been a true leader in that issue 
for a long, long time.
    Mr. Markey. Thank you, Mr. Chairman, very much. You and I 
created the Alzheimer's Task Force 13 years ago, and I think we 
are really making progress on the issue. But at the same time, 
5.4 million Americans now have Alzheimer's, 15 million baby 
boomers will have Alzheimer's. If we don't find a cure for 
Alzheimer's, that one disease will equal and exceed the entire 
defense budget of the United States in Medicare and Medicaid 
payments for those families. Last year it was $132 billion in 
Medicare and Medicaid that went just to Alzheimer's.
    So the numbers are absolutely staggering. Within a 
generation, there will be more people over the age of 60 than 
under the age of 15. So, you know, we are in a race against 
time here in terms of our ability--that is across the whole 
planet. And so this isn't just a national, but an international 
issue because you can multiply the consequences, you know, for 
America across the whole rest of the population of the world, 
and it is imperative for us to have action plan that does work 
because failure is not an option here. We, like the Apollo 
astronauts coming back, we have to fabricate some way of 
finding the clues that will make it possible for us to make it 
possible for children to have to look to the history books to 
find that there ever was such a disease as Alzheimer's.
    But it is something that I think has to be bipartisan. And 
your leadership and Congressman Payne's leadership helps to 
demonstrate that. And thank you for inviting me here today. 
Thank you, Doctor, for all of your incredible work on this 
issue.
    Mr. Smith. Mr. Markey, thank you very much for your 
leadership over all these years. In a place where 
bipartisanship seems to be diminished, there are some issues 
where that is simply not the case, and this is one of those. It 
has been great to work with you those 13 years on this issue, 
and may it continue.
    Mr. Markey. Thank you.
    Mr. Smith. I would like to now introduce our first very 
distinguished witness, Dr. Richard Hodes, who has been director 
of the research program at the National Institute on Aging at 
the National Institutes of Health since 1993. Dr. Hodes has 
devoted his tenure to the development of a strong, diverse, and 
balanced research program. He focuses on the genetics and 
biology of aging, basic and clinical studies aimed at reducing 
disease and disability, including Alzheimer's disease, and 
investigation on the behavioral and social aspects of aging. He 
is the author of many research papers, and is an active 
scientist in and contributor to the field of immunology. His 
full, very, very impressive resume will be made a part of the 
record. I would like to ask Dr. Hodes to proceed as he would 
like.

STATEMENT OF RICHARD HODES, M.D., DIRECTOR, NATIONAL INSTITUTE 
            ON AGING, NATIONAL INSTITUTES OF HEALTH

    Dr. Hodes. Thank you, Congressman Smith, Congressman Payne, 
Congressman Markey, for the opportunity to be here and talk 
with you about international aspects of Alzheimer's disease, in 
particular Alzheimer's research. All of you have very 
effectively introduced the magnitude of the problem at an 
individual, personal, and social level, and the international 
nature of it. The projections for future increases in 
Alzheimer's, moreover, are predicted to affect 
disproportionately the less developed parts of the world, again 
emphasizing the international aspects of what is yet to come.
    Overall, the science and pursuit of solutions to 
Alzheimer's research is international. It is marked by some of 
the events that have been discussed already. International 
scientific colloquia, such as the International Conference on 
Alzheimer's Disease, which will be held next month in France, 
typify the opportunities for scientists from around the world 
to share information in the goal of constructing the most 
efficient and effective plans for attacking the problems.
    In addition, also referred to after passage of NAPA, the 
National Alzheimer's Project Act, there has been institution at 
DHHS of an interagency committee that is charged with 
coordinating efforts, including most notably, as read from that 
bill, efforts at an international level to consolidate and 
coordinate levels, and those are very much underway already.
    I would like to present in the next few minutes some of the 
examples in which the international approach has been 
particularly important in pursuit of Alzheimer's research in 
three areas that I will typify, one of them being the area of 
basic research, the attempt to identify the underlying 
pathogenesis, the processes that lead to Alzheimer's; second, 
the translation of this to early diagnosis, the ability to 
track disease and to facilitate the testing of interventions; 
and then finally, also alluded to, research aimed at addressing 
the great burden of caregivers, who currently constitute the 
major force for care of individuals with Alzheimer's disease.
    Over the last years, we have instituted, for example, 
through NIH support a project called DIAN. It is a Dominantly 
Inherited Alzheimer's Disease Network. As alluded to, 
Alzheimer's is typically a disease of older individuals, but 
there is a relatively rare, though particularly tragic 
inherited form that can occur in individuals in their 30s and 
40s and 50s. The disease is rare, but presents an unusual 
opportunity to study the features of Alzheimer's disease with 
perceived clinical manifestations because it is so predictable 
in these individuals that sadly 100 percent assurance that over 
subsequent years they will develop Alzheimer's.
    An initial collaboration between the United States, the 
United Kingdom, and Australia, soon to be joined by other 
nations, will look at the individuals from these families who 
are rare but exist in many parts of the world, to achieve a 
number of them to allow meaningful studies to better understand 
the processes that exist many years or even decades before 
Alzheimer's disease, and in turn to address them before 
irreversible symptoms and damages occur.
    Also important has been the discovery of genetic risk 
factors for the more common form of adult onset, late onset 
Alzheimer's disease. Here, the techniques of GWAS, or genome-
wide association studies, have been particularly important. And 
the international aspects here again I once more emphasize, 
because of the need to study large numbers of individuals, 
including individuals in diverse environmental contexts in 
order to understand the genetic risk factors, in the past years 
a number of new genes have been discovered through 
collaborations of investigators in the United States, Canada, 
and Europe. And just this year a new consortium worldwide will 
collect approximately 40,000 individuals with Alzheimer's 
disease, allowing a still greater sensitivity in understanding 
the genetic factors that affect the disease, and in doing this 
to find targets for potential intervention.
    Another approach that has been critical is the 
identification of early changes in Alzheimer's that allows not 
only for early diagnosis, but the means to track progression of 
disease. This is most important so we become more efficient in 
testing whether products are or are not effective. Currently, 
these trials generally mean treating several hundreds of 
individuals and waiting the years it takes to determine whether 
clinical course has been varied. New research looking at 
biomarkers that involve neuroimaging and spinal fluid 
chemistries have made enormous breakthroughs in past years.
    In particular, an initiative called ADNI, the Alzheimer's 
Disease Neuroimaging Initiative, is really a remarkable 
precedent in which private sector, public sector, Federal, and 
not-for-profit and academic representatives have converged on a 
project which has made available now new means in the research 
setting for tracking disease through changes in structure and 
function years and even decades before the appearance of any 
symptomatology, and now promise to find the same predictive 
value in tests of cerebrospinal fluid.
    In order to increase the power and again the international 
scope of this, there have now been ADNI-like initiatives that 
are already in place in Europe, in Australia, and in Japan. 
There are additional efforts that are in progress now being 
established in China, in Taiwan and Korea, once again 
exemplifying the power that will come with coordinating efforts 
across nations to understand the factors which are in common 
and as well the factors which are independent and may vary from 
country to country.
    So specific examples in which comparison of effects in 
different countries is important and can be outlined as well. 
One, which you will hear about subsequently this afternoon from 
Hugh Hendrie, has been a remarkable study, the Ibadan-
Indianapolis study, in which Nigerians living in Ibadan and 
those of Nigerian descent living in Indianapolis are compared 
for the factors which determine Alzheimer's and other forms of 
dementia, again allowing a real and powerful opportunity to 
dissect genetic and environmental influences.
    Similarly, there are collaborations with Israel studying 
the way in which diabetes is a risk factor for development of 
Alzheimer's disease; and recently, with assistance through 
U.S., institution of a study in China that is looking at the 
potential effects of exposure to trace elements on development 
of cognitive loss and dementia.
    Finally, I would turn to the emphasis that was placed here 
now, so long as we still have individuals suffering with 
Alzheimer's and have to provide the best care we can to them 
and their care providers, NIH has also supported research aimed 
particularly at the well-being of care providers. The study 
REACH, Resources to Enhance Caregiver Health, has identified 
through clinical trials just as rigorous as those for drugs, 
interventions which are capable of decreasing the stress, 
depression, other health, adverse health outcomes in those 
individuals who are caring for patients with Alzheimer's, and 
has also been effective in delaying the time of 
institutionalization so individuals with Alzheimer's are able 
to spend more time at home with their families and loved ones.
    This study has been disseminated in the U.S. now very 
effectively through the Department of Veterans Affairs and the 
Administration on Aging, and we are looking similarly to extend 
this to an international level. Most recently, the very first 
of these efforts has been put into place in Hong Kong, where 
again in consultation U.S. studies of the outcomes of these 
clinical trials, we will have an opportunity to begin the 
process of international dissemination of these effective 
interventions.
    Just as has been described, the problem of Alzheimer's is 
international, and will remain so, and for that very reason the 
research approach to it has to remain an international effort, 
and we at NIH and across the HHS are committed to this with 
many powerful beginnings and the prospect of much more to come.
    And I thank you for this opportunity to speak with you and 
look forward to addressing any questions you may have.
    [The prepared statement of Dr. Hodes follows:]

    
    
    
    
    
    
    
    
    
    
    
    
                              ----------                              

    Mr. Smith. Thank you very much, Dr. Hodes, for your 
testimony, and for the tremendous leadership you provide. Let 
me ask just a couple questions with regards to the sharing of 
data among scientists around the world.
    How robust is it? Is there a stovepipe mentality, or are 
scientists funded by your shop and others more than willing to 
share findings and to collaborate?
    Dr. Hodes. Although there is always room for improvement, I 
think that there is an enormously positive attitude of data 
sharing in the area of Alzheimer's research. To cite a couple 
examples or expand upon those that I mentioned, for example in 
the field of genetics, as we have studied the power that is 
needed to carry out genetic evaluations, we have quickly 
learned that the number of individuals studied by any one 
laboratory or even any one nation are often insufficient to 
make the discoveries that are needed. So some of the great 
discoveries the past years have come through voluntary 
participation, collaborations from investigators in many 
nations studying populations of these nations to accumulate the 
power needed for clinical trials and these clinical 
evaluations.
    The ADNI study, as I mentioned, is particularly informative 
because it stresses not only the willingness to collaborate, 
but sometimes the technical advances that are necessary in 
order to achieve collaboration. So what ADNI did in terms of 
its neuroimaging capacity was to establish the methodologies 
that allow individuals to be scanned by different machines, 
brain scans, in different parts of the country and in different 
parts of the world, and to make those compatible so that one 
could translate them into a common language, compare one 
subject or patient to another. With this enormous benefit, it 
is now possible to share the neuroimaging and other data from 
ADNI nationally and internationally.
    The international efforts that I mentioned are being taken 
with great care to harmonize so there will be a common language 
to allow translation. And I think with these technical issues 
addressed, we generally are finding very gratifying 
collaboration across nations.
    Mr. Smith. Let me ask you, you mentioned the caregiver 
issue. I know that the veterans, because I used to be chairman 
of the Veterans' Affairs Committee, we had a very important, I 
think, Alzheimer's project, the REACH program: Resources for 
Enhancing Alzheimer's Caregiver Health. Have you gleaned 
lessons from them? And what are you finding with regards to 
caregivers? And secondly, in planning, the United States 
doesn't seem to be as poorly off as some countries in Europe. 
And again having just had this hearing, and without objection, 
I would like to make all four of the demographers' testimonies 
from Monday's hearing part of this hearing, because the impact 
of not having children and caregivers is going to be enormous 
both in terms of the patients themselves and on health care 
delivery systems worldwide.
    As I mentioned in my opening comments, it is catastrophic. 
It is a demographic winter that is just around the corner all 
over the world. And I mean one statistic that I found troubling 
in Russia, this was Nicholas Eberstadt provided this to our 
commission on Monday, for every 2 million births there are 3 
million deaths in Russia. So I mean they are rapidly losing the 
ability to--plus an aging population--to have a caregiver 
available for an Alzheimer's patient. Your thoughts on that? Do 
you collaborate, for example, with CMS or with HHS about 
projections of what costs really will be as the caregiver pool 
dries up even here in the United States and people then have to 
go into an institutionalized setting?
    Dr. Hodes. There are a number of extremely important and 
good points made. The first of them, the question of how the 
Department of Veterans Affairs, and again I would add, the 
Administration on Aging, have been effective in translating the 
programs of research are a very important illustration of the 
way in which Federal agencies can collaborate. So the 
discovery, the demonstration in an experimental setting, a 
clinical trial that something is effective now needs to be 
followed up by these organizations, which in effect are doing 
demonstration projects, translating them into the real world. 
We work very closely, in fact our last meeting with the 
Department of Veterans Affairs was just last week, to monitor 
these outcomes. And as I mentioned, their translation 
internationally is beginning to occur as well.
    The demographics you described are indeed imposing and are 
a part of all our projections. So that even as we expressed 
optimism about a program such as REACH, which allows caregivers 
to take better care of those with Alzheimer's, which is 
critically important in the present, as your remarks explain, 
we in the future may not have sufficient numbers of caregivers 
even with the best of circumstances to support, to care for 
those with Alzheimer's, meaning that institutionalization may 
become an undesirable but only alternative, which all turns to 
emphasize yet once again the urgency of our finding a way to 
decrease the burden of Alzheimer's, to prevent and treat it, 
because even the best of caregiving circumstances is going to 
be compromised by the very demographics that you described.
    Mr. Smith. Let me ask you, is the 115 million Alzheimer's 
patients by 2050, as provided by Alzheimer's Disease 
International, is that order of magnitude what you think is 
accurate?
    Dr. Hodes. I think it is very appropriate you asked about 
order of magnitude. And the answer is yes. You will see and 
hear and read many differences that have to do with projections 
based on different numbers of individuals currently affected. 
And that has to do with diagnostic criteria, with different 
predictions of birth rates, death rates, and longevity in 
populations. With so many unknowns there, it is unavoidable 
there is going to be a range of uncertainty in projections. But 
for order of magnitude, that seems to be precisely within the 
range of multiple proposals and projections.
    Mr. Smith. A couple of final questions. In your opinion, 
are we on the verge of a chemical compound therapy intervention 
that might lead to at least arresting the progression of the 
disease? And can you make any kind of prediction that a cure 
might be found in the not too distant future?
    And secondly, George Vradenburg and Eric Hall both make a 
very strong appeal for an international meeting to share best 
practices. I would hope that it would be at the very highest of 
levels, presidents; secretaries or ministers of health, or 
Secretary of Health and Human Services in our case; and then an 
NGO inclusion, not just a side event, but something where they 
would really, the NGOs around the world, including here in the 
U.S., could really participate and be a part of it so that we 
could all share best practices.
    Eric Hall talks about the extraordinary work being done in 
Israel, for example, and how we might learn from that. You 
mentioned the Nigerian diaspora here and those in Nigeria, what 
we could learn from that. I mean, there are huge lessons 
learned. And if we were to push for this, which I am going to 
introduce a bill, or try to get some funding for it, I know my 
colleagues will all work collaboratively for that, off the top 
of your head do you think it would be a good time, 2012, as 
recommended by the Alzheimer's Foundation, or could it be done 
sooner?
    Dr. Hodes. So to the first question, of course I wish that 
I could estimate the time in which we will finally achieve the 
kind of effective interventions that we want. But what I can 
express for myself is the shared enthusiasm about scientists in 
the field for the undeniable and enormous pace of discovery. 
The amount we understand about the basic underlying processes, 
the degree to which we can now in individuals who are alive and 
either with or without symptoms, the underlying brain changes 
that are occurring enable an efficiency of clinical trials and 
tests on newly identified targets that is unprecedented. And so 
the pace of discovery will enhance. Just when that will 
converge on a final successful solution is certainly beyond my 
ability to predict.
    Your question about convening an international meeting, 
again I would emphasize that at the scientific level these 
meetings occur and need to occur, such as the ICAF that is 
coming up. What you are talking about, what has been proposed 
is a meeting at a larger level that goes beyond research to the 
application of research, the societal implications, the best 
practices. And here I can only express the great enthusiasm 
that we at NIH and others would have to make sure that we 
contribute to the evidence base and learn from such an exercise 
more about what the priorities need to be so that we can direct 
our research to best serve the process. So we would be 
certainly enthusiastic participants in such an activity.
    Mr. Smith. And I think the political buy-in of having at 
the highest level Prime Ministers and Presidents, if that could 
be arranged, would make an enormous difference. You know, G-8, 
G-20 and the rest of the world. Thank you very much. And I do 
hope that is something that the administration could support 
very strongly as well, because it would take planning now to 
make that happen in the very near future.
    Mr. Payne.
    Mr. Payne. Thank you very much. Thank you for your 
testimony.
    As we know, we are in a new economic era here as we proceed 
to deal with the debt and the deficit, and as we are embarking 
on having a broader approach to the problem of Alzheimer's here 
in the United States, but also abroad. I just wonder what, in 
your opinion, you know, have you seen as effective in the U.S. 
support of global dementia? And in your opinion, what steps 
could the U.S. Government take in order to improve our support 
of this global health issue? As I mentioned, we are sort of 
moving in the other direction, but this is such a devastating 
health issue, I just wonder if you have any advice that we 
might be able to use.
    Dr. Hodes. Well, again I think from the perspective of an 
agency committed to research to identify best practices and 
means for intervention, it certainly is the translation of 
research findings as they currently exist, such as in areas of 
REACH that are likely to be effective.
    You touch upon another area where there has been a good bit 
of controversy of late, that is in terms of what we know about 
how to translate apparent risk factors for Alzheimer's disease 
into recommendations for interventions that are likely to 
decrease the probability of developing Alzheimer's. And there 
was a state of the science conference that was carried out by 
bringing in experts who reported about 1 year ago to NIH. They 
concluded, in language that really requires clarification, that 
there was no high quality evidence indicating that any 
intervention, for example, based on control of behavioral 
factors or blood pressure was proven to prevent Alzheimer's 
disease development. This created I think an unfortunate 
perhaps over-interpretation of the fact that we don't know what 
we can reasonably recommend. The clarity of evidence will 
continue to increase as we do more clinical research.
    But there is certainly strong associative evidence that 
suggests that people with high blood pressure, as you alluded 
to, with diabetes, people who don't exercise, people who don't 
have social connectivity are at higher risk for Alzheimer's 
disease. And even as we continue to develop better research, 
the ability to support appropriate treatment of these 
cardiovascular risk factors and environmental factors is I 
think a very reasonable recommendation at this point in time.
    So disseminating that nationally and internationally I 
think is an appropriate use of the evidence base that we were 
able to generate and we continue to generate at the present 
state of knowledge.
    Mr. Payne. That sort of leads into another thought that I 
had that, as I mentioned in my testimony, that figures indicate 
that the majority of dementia cases are located in low to 
middle income countries throughout the world. Additionally, the 
World Health Organization estimates that currently 58 percent 
of the worldwide dementia is in moderate income countries. But 
of course the dilemma is the future, where it is estimated that 
71 percent by 2050 will be in countries in that category. So I 
am just wondering what, in your opinion, do you think can be 
done in order to halt the growth of dementia cases? And 
additionally, what capacity building is being done in low and 
middle income countries so that they are better prepared to 
handle dementia cases, and much more of them as they will be 
coming in the coming years? Are they willing to listen? Do they 
feel it is an issue that, with all their other problems, that 
should be raised to a higher level? What has been, in your 
opinion, the response from countries in this category?
    Dr. Hodes. I think one very important aspect of what you 
raise is the fact that as we have increasing proportions of 
individuals affected with dementia in less developed countries, 
we have to take great care to be sure that what we identify as 
causes and interventions that are effective for preventing or 
delaying Alzheimer's are solutions that will be relevant to 
many parts of the world. And for example, the relative 
importance of risk factors such as hypertension or diet versus 
genetics may well vary from one part of the world to another. 
Whether dementia caused by what we identify pathologically as 
Alzheimer's disease versus that which has more important 
components of vascular disease is a critical determinant.
    I think you will hear more again from Dr. Hugh Hendrie as 
he talks, for example, about the informative comparison of 
Nigerians in Ibadan versus those of Nigerian descent in the 
U.S. is an example. We see changes in what the risk factors 
appear to be for these presumably genetically similar 
populations. And this itself is informative. But it suggests 
that to the future, as we develop effective interventions, we 
are going to have to pay attention to the likelihood that there 
will not be a single intervention that may be first shown to be 
effective in Bethesda or New Jersey or in Boston, and to assume 
that it will be universally applicable.
    So the research again has to continue internationally. 
Right now it is doing so in terms of risk factors. As we become 
better able to translate into interventions, we are going to 
have to similarly keep in mind that interventions are going to 
have to be tailored to the genetic, environmental, and 
socioeconomic conditions of the various nations of the world.
    Mr. Payne. Just finally, have we been able to determine 
whether there may be a correlation between diet or say weight 
factors, obesity? Have we seen any kind of correlation in your 
studies to those issues?
    Dr. Hodes. Well, there is some very strong correlations 
between high blood pressure and risk of developing Alzheimer's 
disease or dementia, between diabetes and the risk of 
developing Alzheimer's disease or dementia. Now what is 
important is to move from those correlations to asking whether 
if we address blood pressure or control of diabetes we can make 
a difference in terms of cognitive function. And those very 
studies are currently underway. So that for example in the 
studies carried out with support from the Heart, Lung and Blood 
Institute or the Diabetes Institute, which are looking at 
various interventions to treat various levels of control of 
blood pressure or of blood sugar, NIA and other components of 
NIH have added to that measures of cognitive function and even 
of neuroimaging so we will learn in the format of a clinical 
trial whether we can establish evidence that indeed preventing 
high blood pressure or high blood sugar in addition to the very 
likely impact these are going to have on stroke, cardiovascular 
disease, and other complications of diabetes may also have a 
direct impact on cognitive function and risk of dementia.
    So your question directly, yes, there are strong 
correlations. Now even more important, testing to see if we 
intervene on those variables we can translate the correlation 
to find out whether it is causal and leads to a preventive 
intervention is the state that we are at currently.
    Mr. Payne. Thank you very much. I yield back.
    Mr. Smith. Thank you very much, Mr. Payne. I just do have 
one final question. With regards to early-onset, are the risk 
factors the same, similar, or different? And what is the 
earliest onset that has been recorded thus far of Alzheimer's?
    Dr. Hodes. Well, in the category of dominantly inherited 
early-onset Alzheimer's disease, these cases around the world 
are caused by a number of mutations, but in one of only three 
genes. It is essentially 100 percent certain, tragically, that 
someone with this mutation will develop Alzheimer's disease. 
The age ranges have been 50s, 40s, even 30s. They vary somewhat 
with the identity of the population and the genetic mutation.
    In terms of identifying risk factors other than the gene, 
in those cases of course, since the gene is essentially 
determinant, there has been very little opportunity to ask 
whether that genetic predisposition or predestination, sadly, 
is influenced by other factors. So there isn't so much known.
    Now, if we set aside those and ask about the cases of 
Alzheimer's in which there is not a dominantly inherited 
mutation, but nonetheless are recurring not at the more common 
80s or 70s, but occurring in the 60s or 50s, we are currently 
through population studies monitoring onset and prevalence of 
cognitive decline and even Alzheimer's in populations that 
range in age from 50s through the 80s and 90s. For example, the 
Health and Retirement Study puts us in a position to better 
understand whether the risk factors vary with age. An important 
factor in studies currently in progress ought to be able to 
address this.
    Mr. Payne. Just one additional question also. The increase 
in the percentage or the number of people that are being 
diagnosed with Alzheimer's, in your opinion do you think it is 
an increase that is happening or do you think that it has 
simply been underreported in the past and just called something 
else?
    Dr. Hodes. I am not aware of any conclusive evidence that 
the risk of developing Alzheimer's disease at a given age, 
other variables essentially being similar, has changed. There 
is room for this to occur. For example, if the epidemic we are 
seeing in obesity and associated diabetes were to continue, it 
is possible that due to an increase in diabetes and the 
associated risk in Alzheimer's there might be such a change. 
But the short answer to your question, to date I think it is 
likely that the increase in what we are seeing is due to two 
principal factors, overwhelmingly the increase in the number of 
people who are reaching an age at which they are at higher 
risk, and in addition the greater awareness and diagnosis.
    Mr. Smith. Finally, Dr. Hodes, could you give us a sense of 
how many laudable research proposals go unfunded because of 
inadequate funding?
    Dr. Hodes. I can give you an answer which I think shows the 
magnitude of that category. Currently, the pay line, that is 
the percentile at which applications are being funded at NIA, 
and it is not so different across other components of NIH, this 
year for example for the bulk of grants is at the 11th 
percentile. I think there would be little disagreement, if any, 
that grants that receive percentile scores at least twice that 
level, into the 20s, are deemed by peer review to be 
outstanding. By that criterion, I would say that we could fund 
twice as much research as we are currently able to fund, and 
still be funding uniformly outstanding research, if that is 
responsive to the question.
    Mr. Smith. That is very helpful. Thank you so much, Dr. 
Hodes. Thank you so much for your testimony. We look forward to 
working with you. Did you say if you would personally, or on 
behalf of the administration, be able to support an 
international conference?
    Dr. Hodes. Of course I can't speak for the administration. 
I can certainly say if there is such a conference, then I would 
be enthusiastic about there being a presence of agencies such 
as NIA and NIH to lend their perspective on evidence and to 
learn from such a conference about where research ought to be 
conducted. But beyond that----
    Mr. Smith. Clear it with OMB. Thank you very much, Dr. 
Hodes.
    I would like to now introduce our second panel. And without 
objection, I would like to make part of the record, as I 
indicated earlier, the four demographics experts who testified 
on Monday at the Commission on Security and Cooperation in 
Europe. And that is Dr. Nicholas Eberstadt, Dr. Jack Goldstone, 
Richard Jackson, and Steven Mosher. Without objection, it will 
be part of record.
    I would like to now introduce our second panel, beginning 
with Dr. Daisy Acosta, who is Alzheimer's Disease 
International, chairman of ADI, which seeks to empower the 75 
national Alzheimer's associations around the world to promote 
and offer care and support for people with dementia and their 
caregivers, while maintaining a global focus. She is certified 
by the American Board of Psychiatry and Neurology, and Dr. 
Acosta specializes in geriatric psychiatry. She has a large 
clinical practice in the Dominican Republic, and is in charge 
of organizing and teaching at the university psychogeriatric 
unit in that country. Welcome, Dr. Acosta.
    We will then hear from Mr. Eric Hall, who is the President 
and founding CEO of the Alzheimer's Foundation of America, and 
President and CEO of Alzheimer's Foundation International, an 
outgrowth of AFA. Mr. Hall spearheaded the development of AFA 
to improve the quality of care for individuals with Alzheimer's 
disease and related dementias and their families. During that 
goal, he has initiated major national initiatives related to 
early detection, training of health care professionals, and 
standards for dementia care settings. Mr. Hall has spoken at 
numerous conferences on Alzheimer's disease and caregivers, and 
sits on leading advisory councils.
    We will then hear from Mr. Bill Thies, who is Chief Medical 
and Scientific Officer at the Alzheimer's Association, which is 
dedicated to eliminating Alzheimer's disease through the 
advancing of research, providing care and support for all 
affected by the disorder, and reducing the risk of dementia 
through the promotion of brain health. Mr. Thies oversees a 
research grants program at the Alzheimer's Association. He 
launched Alzheimer's & Dementia, the journal of the Alzheimer's 
Association, and established the Research Roundtable, a 
consortium for industry, academia, and government, who meet 
regularly to explore topics of mutual interest in drug 
discovery and common barriers to progress.
    We will then hear from Mr. George Vradenburg, who is the 
founder of USAgainstAlzheimer's, a national disease advocacy 
network, and chair of the Geoffrey Beene Foundation-Alzheimer's 
Initiative on Early Diagnosis. Mr. Vradenburg also directs 
Leaders Engaged on Alzheimer's Disease, a tri-sector coalition 
of Alzheimer's-serving organizations. The USAgainstAlzheimer's 
co-convenes with the Alzheimer's Foundation of America. Mr. 
Vradenburg was drawn to Alzheimer's advocacy through the death 
of his mother-in-law, Bea Lerner, from the disease. Prior to 
2003, Mr. Vradenburg held several executive positions in large 
media companies.
    We will then hear from Dr. Giovanni Frisoni, who is 
currently with the Scientific Institute for Research and Care 
at Brescia, Italy, where he oversees research on Alzheimer's 
and other neurological diseases. In addition, Dr. Frisoni is 
part of several international groups that are focused on 
Alzheimer's research and treatment. His work is widely 
published in medical journals and books. In the past 6 years, 
Dr. Frisoni's work has become more expansive, focusing on 
developing infrastructure for storing and processing brain 
imaging data to increasing the understanding of Alzheimer's in 
Europe and in the United States. He will be joining us live 
from Italy in the order that I am announcing.
    We will then hear from Dr. Jeffrey Cummings, of the 
Cleveland Clinic Lou Ruvo Center for Brain Health. Dr. Jeffrey 
Cummings is director of that clinic for brain health in Las 
Vegas, Nevada, and Cleveland, Ohio. In addition to many 
articles and books, Dr. Cummings is the author of the 
Neuropsychiatric Inventory, which is the most commonly used 
tool for characterizing behavioral disturbances in dementia 
syndromes, and for measuring the effect of therapies on 
neuropsychiatric symptoms in Alzheimer's disease. Dr. Cummings 
has served as president of the Behavioral Neurology Society and 
the American Neuropsychiatric Association.
    We will then hear from Dr. Hugh Hendrie, Professor of 
Psychiatry at Indiana University, where he directs the IU 
Center on Aging Research. Dr. Hendrie served as chairman of the 
Department of Psychiatry, a position he held for 25 years, 
until 2000. While in that position, Dr. Hendrie developed and 
directed a section focused on geriatric psychiatry. He served 
as the President of the American Association of Geriatric 
Psychiatry and The Geriatric Psychiatry Alliance. Dr. Hendrie 
is well known internationally for his research and published 
works on psychiatry. He is currently serving on the National 
Advisory Council on Aging.
    And that is it. Dr. Acosta, if you could begin, please.

STATEMENT OF DAISY ACOSTA, M.D., CHAIR OF THE EXECUTIVE BOARD, 
               ALZHEIMER'S DISEASE INTERNATIONAL

    Dr. Acosta. Thank you, Chairman Smith, Ranking Member 
Payne, for this opportunity to testify before you today. My 
name, as you said, is Daisy Acosta, and I come from the 
Dominican Republic. I am a caregiver, a doctor, and a 
researcher, and I am the chairperson of Alzheimer's Disease 
International, the worldwide federation of Alzheimer's 
associations around the world. Our 76-member associations 
represent the people with dementia and their families in their 
countries. Alzheimer's Disease International was founded here 
in this country in 1984, being the U.S. Alzheimer's Association 
one of our founding members. Today, 27 years later, for the 
first time ADI has a chair from a developing country. So you 
can be sure that I am very proud of that.
    Alzheimer's disease and other dementias, as you have been 
saying, is a global problem, and are the single most important 
health and social crisis of the 21st century. The impact of 
this disease today is massive, and will accelerate with the 
years to come. You have already said how many people live with 
dementia at this point, 37 million people. And this is going to 
increase due to global aging by more than 1 million per year, 
as you said before, to 115 million by 2050.
    Alzheimer's disease is devastating not only to the victims, 
but also to the families and to society at large, and there is 
something really that cannot be put in papers about the 
devastation of this illness. It is the human fiber of this 
illness. You really have to live with a person with dementia, 
with a family with dementia at least for 24 hours to understand 
the urgent need that we need to solve this problem.
    Alzheimer's disease in developing countries, the burden of 
this disease falls completely on the families. And as you said 
before, again, these countries will see the largest increase in 
numbers in the next decades. So I want to stress again that 
this is a global problem, and that we have to find global 
solutions.
    The global cost of this illness, as you said, is $604 
billion. This equals 1 percent of the global GDP. If 
Alzheimer's disease were a country, it would be the 18th 
largest economy based on GDP. And it exceeds that annual 
turnover of any company in the world. And as you said, because 
I am glad to see that you really have all the facts with you 
and all the statistics with you, which is really great, but 
Alzheimer's Disease International put together all this data in 
our two reports, the 2009 and 2010 reports, not just to sit in 
those reports. The aim to gather all this data was really to 
serve as a wakeup call for governments, leaders in the 
community, health care professionals, to really put this data 
into action.
    We have made great progress with many other diseases like 
cancer, HIV/AIDS, but we have done so because there has been a 
political commitment to act, and because of national planning 
and substantial investment in research and care options. And 
this is exactly what is needed to solve this problem.
    There is increasing awareness about Alzheimer's disease and 
other dementias in the world. Several countries have launched a 
national plan or strategy, starting with Australia in 2005, and 
then France and South Korea in 2008. These plans have started 
creating significant changes in health care systems. More and 
earlier diagnoses are being made, better disease management, 
and increased research are key issues in this strategic 
planning. All of these governments are aware that investments 
made now will reduce future health-care costs.
    At our annual international conference in March 2011 in 
Toronto, we hosted for the first time a symposium looking at 
the results of these national plans. And we will do the same 
thing in 2012. And I certainly hope to see the national plan 
for Alzheimer's disease and other dementia in this great 
country being included in this symposium next year.
    The United States has shown global leadership in the past 
and was one of the first countries to create a dementia 
research budget in the 1990s. Having said that, as I 
understand, that budget has not followed the increase in number 
of people with dementia that has doubled in the last 20 years. 
And that budget has not been adjusted for inflation, as I 
understand.
    Your Congress has now taken an important step by passing 
the National Alzheimer's Project Act. I congratulate the USA on 
this decision because it is a great opportunity to improve the 
ways that your health care system deals with dementia: Earlier 
diagnosis and intervention; giving more people access to 
medical and nonmedical treatment; and last, but not least, and 
I think it is extremely important, support for caregivers.
    This should be accompanied, of course, by increased budgets 
for research into the cause of the disease and possible 
prevention.
    If the USA takes these steps, it will encourage governments 
in other parts of the world, as well, to do so. And I am sure 
of that; at least, that will be so in my region where I live.
    ADI--and this is very important--and its members have 
empowered people with dementia to have a voice. I commend you 
to continue the productive work with the Alzheimer's 
Association as a champion in advocacy and encouraging research 
efforts in your country.
    Finally, we need the help of the U.S. Government in an 
international issue. The United Nations are going to hold a 
high-level meeting on the 19th and 20th of September in New 
York City. It is a meeting about noncommunicable diseases. This 
summit currently does not include Alzheimer's disease as one of 
the noncommunicable diseases--only cancer, diabetes, and heart 
and lung diseases--although these illnesses share the same risk 
factors and often coincide together. It would be great if a USA 
representative at the United Nations could raise this in the 
discussion on the outcome document that has already started.
    I think we really can win this fight against dementia, but 
only if governments get committed to do so. And we have no time 
to waste. The time to do it is now. It is time, really, for 
global action.
    Thank you very much.
    [The prepared statement of Dr. Acosta follows:]

    
    
    
    



                              ----------                              

    Mr. Smith. Dr. Acosta, thank you much for your testimony 
and your leadership.
    Mr. Hall?

   STATEMENT OF MR. ERIC HALL, PRESIDENT AND CHIEF EXECUTIVE 
           OFFICER, ALZHEIMER'S FOUNDATION OF AMERICA

    Mr. Hall. Chairman Smith, Ranking Member Payne, thank you 
for convening this hearing and for inviting the Alzheimer's 
Foundation of America to testify. I am Eric Hall, AFA's 
founding president and CEO, and I am honored and privileged to 
be here today.
    My involvement in this cause is not simply a career 
endeavor, and it is more than simply my family history, as if 
that would not be enough, but it is a painful result of the 
many stories that I hear from struggling families across our 
country. I need to do something, we need to do something, and I 
beg you to make the most of the present opportunity and to make 
it happen now.
    The National Alzheimer's Project Act passed by Congress 
last year was a groundbreaking first step toward the creation 
of a National Alzheimer's Disease Plan in the United States. 
However, it is no secret that the U.S. is behind the curve of 
several other countries that already have national Alzheimer's 
disease plans in place or in process. We have a lot of homework 
to do, but we can learn a lot from what has already been done 
overseas, both in planning and in political commitment.
    The next crucial step is an international meeting of 
countries with plans in place or in process in the first 
quarter of 2012. AFA would be honored to serve as an NGO 
supporting partner in such an effort and would be glad to work 
with ADI and others. AFA applauds ADI for its financial support 
of the 10/66 Dementia Research Group and its commitment to 
international collaboration.
    In AFA's view, the international meeting would ideally 
consolidate how other countries have approached their plans and 
would produce a compendium with common threads. Such a meeting 
would help us develop our plan and help us to begin to develop 
a global approach to this pandemic.
    The meeting would also include a day or more of panel 
discussions on established policies, as well as innovative care 
programs abroad as well as those here in the United States, of 
which there are many. There is little doubt we can get there 
faster by reviewing what has already been done, what has been 
successful, and what to avoid.
    One example that the U.S. can learn from is the award-
winning dementia care available in Israel through an 
organization called Melabev. Melabev is a founding member 
organization of the Alzheimer's Foundation of Israel. And, 
together, they share a combined commitment to serve the 
Alzheimer's population in that country. The Alzheimer's 
Foundation of Israel is a not-for-profit organization that I 
established in January of this year through the Alzheimer's 
Foundation International, which has been an outgrowth of the 
Alzheimer's Foundation of America.
    Melabev has spent the last 30 years developing therapeutic 
activities that give people with dementia and Alzheimer's 
disease a reason to get up in the morning. In addition to its 
day centers, Melabev also brings services and activities right 
into the family home. Each individual with dementia is given a 
geriatric assessment, and a range of health-care professionals 
are available for working with the individual and the family 
members under their roof.
    Not only does Melabev care for the person with dementia, 
but it also cares for the family caregivers. It provides 
palliative care for individuals in the end stages of the 
disease, as well as guidance on end-of-life issues for the 
whole family. In between regularly scheduled house calls, the 
members of this team are accessible by phone whenever needed. 
Melabev, quite simply, gives families a shoulder to lean on.
    Israel also has groundbreaking geriatric programs at Herzog 
Hospital in Jerusalem. Their motto is, ``Restoring dignity to 
all.'' Herzog Hospital is currently the only facility in Israel 
to combine neurological, behavioral, and social approaches in 
treating the full range of geriatric illnesses, including 
Alzheimer's disease. Most uniquely, Herzog also has a 
specialized emergency room for behavioral and psychiatric 
issues. And all of its staff members, from physicians to social 
workers, are trained in geriatric approaches to care.
    Melabev and Herzog Hospital in Israel are just two quick 
examples of the many innovative programs available throughout 
the world. A congressional call for an international meeting is 
how we will learn more. And if we do things right, an 
international movement will follow.
    I would like to end with a quote from Peter Drucker, a 
writer who was awarded the Presidential Medal of Freedom in 
2002. He said, ``Unless commitment is made, there are only 
promises and hopes; but no plans.''
    AFA looks forward to working with members of the 
subcommittee to address the important issues raised in today's 
hearing. And, of course, I would be honored to answer any 
questions you may have.
    [The prepared statement of Mr. Hall follows:]

    
    
    
    
    
    
                              ----------                              

    Mr. Smith. Mr. Hall, thank you very much. And as you heard 
from my opening, I think we would be in one accord to try to 
push the very idea that you and others have espoused. I thank 
you so much for that.
    Mr. Thies?

 STATEMENT OF BILL THIES, PH.D., CHIEF MEDICAL AND SCIENTIFIC 
                OFFICER, ALZHEIMER'S ASSOCIATION

    Mr. Thies. Chairman Smith, Ranking Member Payne, I 
appreciate your giving me the opportunity to speak to you 
today. My name is Bill Thies. I am the chief medical and 
scientific officer of the Alzheimer's Association.
    I spent most of the time I sat in the back of the room 
crossing out parts of my presentation because other people were 
already giving that.
    And I think the numbers are really clear. This is an 
epidemic now. It is big. It is only going to get bigger. I 
think one of the things that we miss if we focus too much on 
the numbers is that this is a truly awful disease. It robs you 
of your memories and abilities, it robs you of your resources, 
and at the end it robs you of your dignity.
    There really is only one way out from under the burden of 
the Alzheimer's epidemic, and that is by having new and better 
treatments to either slow the progression of the disease or 
actually prevent the disease from becoming symptomatic. Those 
sorts of efforts will, in fact, not only have to be done at a 
global level, but they also will benefit the whole world.
    I think that the Alzheimer's Association has had an 
international science program for many years. Some of our 
particular activities have been mentioned. The Alzheimer's 
Association International Conference on Alzheimer's Disease 
that is coming up in Paris brings all of the researchers in 
Alzheimer's from around the world. The international 
consortium, bringing the biggest sort of collections of 
genetics studies together, is one where the Alzheimer's 
Association has been able to step in and fund at the last 
stage.
    I mean, basically, the Association is small by governmental 
standards, certainly. We do have the ability to convene, 
catalyze, and then promote the results of various studies. And 
we will continue to do that as frequently as we can.
    We do believe in collaboration with the scientists. 
Certainly, the Alzheimer's Disease Neuroimaging Initiative 
(ADNI) study that has already been mentioned by Dr. Hodes has 
grown to be Worldwide ADNI, which is hosted by the Association. 
It is particularly important to have those studies grow in an 
orderly way so they really can be used complementary.
    We also have started projects like a European ADNI where we 
can invest a small amount of money. And you will hear from Dr. 
Frisoni later. And we particularly believe in trying to 
identify barriers to progress that actually we can have an 
impact with with our limited budget. So we do things like a 
cerebral spinal fluid standardization project in Europe and the 
United States, which is really designed to make measurements of 
CSF biomarkers really practical in a clinical sense. We look 
for those kinds of projects.
    And the future is clearly going to be determined by some 
legislation that has already been passed. National Alzheimer's 
Project Act (NAPA), I would like to compliment the Members for 
having voted for that. But we not only have to pass NAPA, we 
actually have to implement it, and then we have to devote 
appropriate resources to that implementation. If we don't do 
that, we simply will have a wasted exercise.
    And, finally, I would just like to conclude that I don't 
think I have to tell those of you up at the panel that 
activities of the government are not always appreciated for the 
boons that they are. Some people will tend to disagree with 
you. But, in fact, efforts that increase the longevity and the 
quality of the life of the citizen is probably the finest 
public service that you can do.
    We just recently had the national conference of oncologists 
in Chicago, where they announced a variety of highly specific, 
terrifically effective new therapies for cancer. Heart disease, 
over the last 50 years or so, has reduced the number of deaths 
from heart disease by 1 million a year--1 million people a year 
that don't die from heart disease from new science. HIV/AIDS 
has gone from being a virtual immediate death sentence to now a 
chronic manageable disease.
    There is no secret for why that happens. We invest $6 
billion a year for cancer, $4 billion a year for heart disease, 
and $2 billion a year for AIDS. We are at about $450 million 
for Alzheimer's disease. Without increasing that significantly, 
we are going to see the peak of this epidemic and we are going 
to see the worst possibilities of it.
    And what I would challenge the panel to recognize is that 
this is a place where the United States is going to have to 
lead. It is going to have to lead the world, because the rest 
of the world is going to suffer from exactly the same disease 
without the resources to do anything about it.
    Thank you for your attention.
    [The prepared statement of Mr. Thies follows:]

    
    
    
    
    
    
    
    
    
    



                              ----------                              

    Mr. Smith. Mr. Thies, thank you so much for your testimony 
and your extraordinary leadership, as well.
    Mr. Vradenburg?

         STATEMENT OF MR. GEORGE VRADENBURG, FOUNDER, 
                      USAGAINSTALZHEIMER'S

    Mr. Vradenburg. Thank you, Mr. Chairman, Ranking Member 
Payne, Mr. Marino, and Mr. Markey. My name is George 
Vradenburg. I founded USAgainstAlzheimer's last year to try and 
commit this country to solving Alzheimer's, addressing 
Alzheimer's, by 2020.
    You, Mr. Chairman, have already responded to the three 
things that I was urging upon you in your opening comments, so 
I am going to take off in a different direction.
    You talked most eloquently and persuasively about the 
public health crisis that Alzheimer's is and will be becoming. 
I would like to try and take some of what you have said and 
build on it, and say that this is not just a public health 
crisis; it is potentially a fiscal crisis and an economic 
crisis.
    And let me build on that by saying this: There are two 
major demographic changes--two major demographic changes 
affecting the world right now.
    Number one, we are living longer. For thousands of years, 
we used to live to age 30, you know, and then by 1900 it was 
age 50, now it is age 80. That trend isn't going to stop. We 
are continuing to invest in the extension of life. We are 
continuing to do what we have been able to do in overcoming 
infectious diseases and, as Bill just pointed out, what we are 
doing to achieve better results in terms of heart and cancer, 
HIV/AIDS, and others. So we are going to extend life well into 
the 90s, into the 100s. My grandchildren, aging experts tell 
me, will live to 110 to 120. That is number one.
    That particular ability to extend human life has driven 
American economic growth and the growth of the developed world 
since World War II. We have increased our population, we have 
increased our labor participation, we have increased our 
workforce, and, in fact, we have driven economic growth. And 
economists will tell us that, because of that extension of 
life, we probably have doubled or tripled what the GDP would 
have been had we stayed at a life expectancy of 50 to 60 years 
old. That is one demographic change. So there is an economic 
impact to the extension of life.
    The second is the changing role of women in the world. In 
the developed nations, women are increasingly regarded as 
equals. They are increasingly entering the workforce as equals. 
And, as a consequence, they are having fewer children. And that 
means lower fertility rates, and that means that, not only in 
the developed world are we seeing aging and life extension, but 
we are seeing fewer people on the younger end of the scale.
    Now, what does that mean? In Europe, Western Europe, 
Russia, United States to a lesser extent, but in the Asian Rim 
countries, there are declining populations, fewer workers, and 
more people dependent upon public health systems for their 
support. That is producing fiscal stress on health systems 
around the world. And it is producing the risk that the 
developed world, particularly the Asian Rim and particularly 
Western Europe, are going to be declining in their relative 
economic growth and prosperity in the coming years.
    So how is Alzheimer's relevant to all this?
    Number one, as we age physically, as we get to 90 or 100 
years old--after 85, one in two has Alzheimer's--we are going 
to see, increasingly, a physically able population but a 
cognitively disabled population. We are going to be in a 
situation where we are going to be able--some countries are 
going to be able to productively employ their older workforce 
through new technologies and techniques--a physically frail but 
still physically able population--but we cannot engage those 
people because of their cognitive disabilities.
    So we are going to see Alzheimer's actually having an 
adverse effect on economic growth in some nations. And those 
nations that get it right and figure out how to support their 
aging populations, keeping them healthy and keeping them 
productive, are going to be winners in the 21st century. And 
those countries that do not figure out how to solve cognitive 
disability and how to address aging populations are going to be 
losers.
    And, secondly, on the fiscal stuff, Alzheimer's is 
particularly costly. A 10-year duration of the disease. The 
cognitive disability basically means that people forget to take 
their meds for other purposes. So you are going to see 
complications of Alzheimer's--Alzheimer's is going to cause 
complications for diabetes and other diseases. And in the later 
stages of the disease, you will see greater 
institutionalization because of the total dependence of the 
victim.
    As a consequence, there are major fiscal impacts as a 
consequence, particularly, of Alzheimer's. So it is economic 
growth issue, and it is a fiscal issue. So as we focus on what 
to do with our aging populations, we need to change our aging 
populations from people who are taking public benefits through 
our health-care systems, pension systems, and the like and turn 
them into productive taxpayers who are participants in the 
workforce. And that means keeping them healthy. That means not 
just physical health; that means cognitive health.
    And I would suggest, as you have written already, to the 
United Nations on the NCD conference, it is critical for the 
world to begin to recognize this not just as a health issue but 
as a fiscal issue. So, Mr. Chairman, as you were emphasizing 
the importance you attach to the potential of a government-led 
but NGO- and corporate-involved international conference among 
nations that have Alzheimer's plans in place or in process, I 
would urge that the Treasury Department and the finance 
ministers be there as well as the health ministers.
    Because this is an issue that is confronting the developed 
world now. And, indeed, in the developing world, where this is 
going to become a bigger problem, like China, where their 
population will start shrinking in 20 years, this is going to 
have major shifts in the relative economic power, economic 
relationships, and, obviously, the fiscal stability of these 
sovereign budgets.
    So I thank you for the opportunity to be here today. And I 
applaud your leadership and that of Mr. Markey and the other 
members of the committee who are here on this subject.
    [The prepared statement of Mr. Vradenburg follows:]

    
    
    
    
    
    
    
    
                              ----------                              

    Mr. Smith. Mr. Vradenburg, thank you very much for your 
testimony. And your full statement and that of all of our 
distinguished panel--and this is truly a tremendous panel of 
experts.
    My hope is--and, again, as I said this, before I go to Dr. 
Frisoni, we will share this hearing record with policymakers 
throughout the entire world. I actually chair the Helsinki 
Commission, and we meet three times a year, at least. And heads 
of delegations, usually speakers--speaker of the Duma, for 
example--head of the Duma--we will be handing this out, because 
there is a tsunami of disability that is predictable unless 
drastic action is taken. So, again, I thank you all.
    I will now go to Dr. Frisoni, who is coming in from Italy.
    Dr. Frisoni, please proceed.

   STATEMENT OF GIOVANNI FRISONI, M.D. (VIA TELECONFERENCE), 
    DEPUTY SCIENTIFIC DIRECTOR, IRCCS-FBF ALZHEIMER'S CENTER

    Dr. Frisoni. Chairman Smith, Senator Markey, honorable 
Senators of the U.S. Congress, it is an honor to give this 
testimony to the U.S. Congress.
    The aim of my testimony is to stimulate greater 
coordination of large research efforts in the field of 
Alzheimer's disease that will be undertaken in Europe and the 
U.S. In the coming years. As has been already underlined, much 
has been understood about how Alzheimer's disease develops in 
the brain, thanks to research carried out in Europe, the U.S., 
and elsewhere in the past decades.
    We currently believe that Alzheimer's develops due to the 
accumulation in the brain of at least two toxic proteins, 
amyloid and tau, that, with the variable contribution of the 
factors that have been mentioned, lead to progressive synaptic 
and neuronal damage. This has allowed us to design drugs that, 
administered sufficiently early in the 30-odd-year-long 
process, should delay or altogether arrest its progression.
    Enthusiasm on these achievements is reflected by a number 
of large research efforts with an innovative approach. While 
such efforts see active cooperation of scientists across the 
Atlantic, unfortunately these are not coordinated at the 
funding level. And I will give you the two most glaring 
examples, one in the U.S. and one in Europe.
    In the U.S., the Alzheimer's Disease Neuroimaging 
Initiative, which has also already been mentioned by Dr. Hodes, 
the ADNI, is probably the largest ever single effort in 
Alzheimer's, entailing 150 million U.S. dollars for 10 years, 
coming from NIA and industry. ADNI aims to describe the natural 
history of the disease at the clinical and biological level 
with a number of highly sophisticated imaging and biochemical 
techniques. In all medical disciplines, ADNI has pioneered the 
paradigm of open access to research data, such that any 
scientist in the world can download an unprecedentedly wealthy 
database and do science on it.
    In Europe, 85 percent of the public research budget of 
European countries are fully controlled at a national level, 
and less than 1 percent is reoriented to collaboration or 
coordination between countries through a number of community 
programs. This may change in the near future with the advent of 
joint programming funding schemes. These are led at the central 
level by the European Commission and aim to support and 
catalyze that 85 percent of research funded by national states 
by establishing closer and robust collaborations. The 
forerunner of all joint programs is the Joint Programming on 
Neurodegenerative Diseases, an effort just recently started and 
focusing mainly on Alzheimer's disease.
    Remarkably, a European ADNI is currently active in Europe, 
thanks to close cooperation between U.S. and EU scientists, and 
the first JPND, Joint Programming on Neurodegenerative 
Diseases, is on a topic, standardization of biomarkers, where 
U.S. and EU scientists of the European Alzheimer's Disease 
Consortium are working closely together, as Bill Thies was 
reminding everyone earlier on.
    The key role of the Alzheimer's Association, to foster the 
transatlantic cooperation among scientists, should be here 
underlined and acknowledged. However, the funding of ADNI in 
the U.S. and JPND in Europe are not coordinated, such that 
scientists very closely aligned at the scientific level in the 
two areas of the world are completely detached when they run 
for grants. Transatlantic coordination might have the obvious 
positive fallout of maximizing the effectiveness and cost-
effectiveness of research.
    Early initiatives, however, are being developed aiming to 
synergize research efforts across the Atlantic. A scientific 
infrastructure is under development, funded by the European 
Commission with overall 9 million euros, that will allow to 
bring the concept and benefits of cloud computing to imaging 
neuroscientists working on Alzheimer's. The neuGRID electronic 
infrastructure will allow global scientists to exploit the 
enormous amount of scientific information conveyed by large 
public datasets such as the ADNIs.
    The Laboratory of NeuroImaging at the University of 
California at Los Angeles is full partner in the NeuGRID 
efforts. Works are under way, led by the Alzheimer's 
Association, to develop the U.S. chapter of neuGRID, the Cloud 
Network of the Alzheimer's Association, CNAA, where EU partners 
will be symmetrically represented.
    The neuGRID/CNAA example is just a drop in the vast sea of 
Alzheimer's research. Funding bodies may wish to borrow this 
model of cooperation to inform the largest initiatives on 
Alzheimer's in the EU and U.S. If this will happen and be 
effective, more funding bodies, from China, Japan, Australia, 
and elsewhere, may wish to join in.
    In conclusion, global research on Alzheimer's is benefiting 
from enthusiasm of recent scientific discoveries and prospect 
of an effective cure. Decision makers in the U.S. and EU should 
capitalize on scientific enthusiasm by developing more 
effective funding strategies that will allow scientists to 
progress at greater speed. This will increasingly feed the fire 
of enthusiasm of scientists with the logs of knowledge and may 
ultimately lead to find an effective cure for this devastating 
disease.
    And I thank you for your attention.
    [The prepared statement of Dr. Frisoni follows:]

    
    
    
    

                              ----------                              

    Mr. Smith. Dr. Frisoni, thank you so very much. I know it 
is very late there. I hope you can hang on a little bit longer 
for, perhaps, a question or two from the members or, perhaps, 
our panel, who might want to pose a question to you.
    Dr. Cummings?

STATEMENT OF JEFFREY CUMMINGS, M.D., DIRECTOR, CLEVELAND CLINIC 
                LOU RUVO CENTER FOR BRAIN HEALTH

    Dr. Cummings. Thank you, Chairman Smith, Mr. Payne, Mr. 
Marino. It is a pleasure to be here, and I am grateful for your 
willingness to call attention to this tremendous problem that 
we face.
    We haven't heard too much about Africa so far, so I am 
going to say a few things about Africa. And then I am going to 
tell you about a couple of experiments that we are doing at the 
Cleveland Clinic Lou Ruvo Center that we think could be 
exported and could be influential in terms of the way patients 
are cared for.
    So, as you have heard, Alzheimer's disease is age-related, 
and I would like to make the point that the African continent 
is aging, just as every continent is. So there are 36 million 
people in the sub-Saharan African region that are over the age 
of 60. And that predicts a cognitive impairment number, 
population, of around 9 million--Alzheimer's disease, plus mild 
cognitive impairment of various sorts. Dr. Hendrie has done 
terrific work in Nigeria. There are recent reports from the 
Congo and from other republics that suggest that the numbers 
are becoming more comparable to Western numbers over time--that 
is, high.
    For every patient with Alzheimer's disease, there are at 
least two caregivers. So if we say there are 9 million victims, 
then we have to say that there are at least 18 million 
caregivers on the African continent who are involved with 
Alzheimer's disease. That is a tremendous number, a tremendous 
burden.
    The cost of Alzheimer's disease, of course, is terrific. It 
is estimated at $172 billion annually in the United States now. 
Africa is spending $2.9 billion annually on its dementia 
population. And these economies are ill-suited to absorb very 
much more, in terms of care of elderly and demented 
individuals. So they are going to have trouble responding 
meaningfully to the burden, and the increasing burden, that 
this represents.
    Risk factors are very important. And I take Dr. Hodes' 
admonishment that we don't have the kind of data that we would 
like, and it is going to be hard to get. We understand, for 
example, that hypertension in mid-life contributes to dementia 
in late life. Well, that is a long-term experiment, right, for 
you to decide whether reducing hypertension in mid-life is 
going to have an effect 20 or 30 years later.
    So we are not going to have the kind of data that we would 
like to have for intervention. And we are going to have to 
accept some of the correlative data that we have now, such as 
there is an association between Alzheimer's disease and high 
blood pressure, with diabetes, with low educational level, and 
with head trauma. All of those things are overrepresented in 
Africa in the population, and they represent very substantial 
risk factors for cognitive impairment in the African 
population.
    Stroke is a risk factor for Alzheimer's disease. There are 
twice as many strokes in African blacks compared to African 
whites. So stroke is playing a substantial role in Alzheimer's 
disease in Africa.
    Nutritional status is compromised in much of sub-Saharan 
Africa. And we hear a lot about nutrition in children and 
nutrition in lactating women, but we hear very little about 
nutrition in the elderly, and yet it is a risk factor for 
Alzheimer's disease and cognitive impairment.
    Stress is a risk factor for Alzheimer's disease. So think 
of war and famine and refugee status and what that must do to 
the incidence and prevalence of cognitive impairment in the 
African population.
    Behavioral problems--and I am quoting here Dr. Acosta's 
work and the tremendous work of the 10/66 Group--behavioral 
problems such as agitation and depression and sleep 
disturbances are common in Alzheimer's disease. They have been 
shown to be present in 70 percent of dementia patients in 
developing countries--so, very high.
    Dementia has largely been under-prioritized, I think for 
financial and simple educational reasons, in Africa. The 
policies that could be supported would be: Increasing 
awareness; they would be social protection. Mr. Payne, you 
mentioned that when there is displacement of populations, the 
last protected are the elderly. So social protection programs 
would go a long way toward helping this. Access to good-
quality, age-appropriate health care would be very important. 
And reducing disability could make a tremendous impact in the 
lives of these patients.
    Now, I will just tell you about two things we doing at the 
Cleveland Clinic that I think are important.
    One is our patients first philosophy. You have the choice 
of taking the science to the patient or taking the patient to 
the science. So we said, let's put the patient in the middle, 
let's make them the focus, let's try to understand the 
experience they are having. So we took away waiting rooms, for 
example, because we don't think a patient with mild disease 
should be in a waiting room with a patient with severe disease. 
So there are no waiting rooms in our clinics.
    We changed the geography so that there is a circle of flow 
of patients through the clinic and out, so that the only chance 
of one patient encountering another is in the elevator lobby.
    We give a patient a flower when they leave our clinic, 
because we are trying to make this an experience that, if they 
can remember it, they will remember it as a pleasant 
experience, and certainly the caregiver will remember it.
    We have built our caregiver programs around the experience 
of the patients. So we have dance programs, where patients and 
caregivers come together to dance. We have music programs. We 
have weekly ``lunch and learn'' programs. These are the things 
that we draw people into to help make their lives better.
    Finally, we said to ourselves, our interest is in clinical 
trials. I am basically a person committed to new therapeutics 
in Alzheimer's disease. And we have way too few Alzheimer's 
patients coming into clinical trials. A tiny minority of 
patients with Alzheimer's disease are participating in trials, 
and yet trials are the only way to get new drugs approved for 
Alzheimer's disease.
    So we said, let's give the patient the message that they 
can help solve this problem; that doctors and scientists, 
without the help of the patient, cannot solve Alzheimer's 
disease; that patients have to be part of the Alzheimer's 
disease solution. So we empower them to be part of the solution 
for Alzheimer's disease by participating in clinical trials. 
And we have some of the highest participation rates in the 
country for our patient population in clinical trials.
    Now, a final point about clinical trials and an experiment 
we are trying. By and large, clinical trials are conducted at 
individual sites throughout the country. And they recruit 
slowly; it is the slowest part of every drug-development 
program. And almost no drug-development program finishes on 
time. So we are literally slowing our ability to get to new 
drugs because we cannot conduct the clinical trials fast 
enough.
    In Cleveland Clinic, what we have decided to do is to make 
all of the sites of the Cleveland Clinic clinical trial sites. 
In Nevada, in Ohio, in Florida, everybody is participating in 
clinical trials. It is all controlled by one IRB, because 
regulatory hurdles are a major reason for slowing clinical 
trials. This is one of the barriers that can be solved.
    I will tell you a final point, which is that we recently 
reviewed the 269 Alzheimer's trials being conducted in the 
world now. Only 28 percent of them are being done in the United 
States. So trials have been exported outside of the country 
because we are not able to adequately recruit for them in the 
United States.
    We are very concerned about the quality of some of those 
trials conducted at international sites. We need to solve the 
problem of recruitment. We do not have a national Alzheimer's 
disease clinical trials recruitment program. We need to solve 
that problem so that we can get more patients into trials in 
the United States. And we need better collaboration 
internationally, because most of the trials are being done 
outside of the United States. Our growth in getting new drugs 
for Alzheimer's disease depends on international collaboration.
    I will stop there. Thank you very much for the opportunity 
to speak with you.
    [The prepared statement of Dr. Cummings follows:]

    
    
    
    
    
    
    
    


                              ----------                              

    Mr. Smith. Thank you very much, Dr. Cummings.
    Dr. Hendrie?

 STATEMENT OF HUGH HENDRIE, M.D., PROFESSOR, INDIANA UNIVERSITY

    Dr. Hendrie. Chairman Smith, Ranking Member Payne, and 
other members of the subcommittee, I am just delighted to be 
here, to be invited to this really remarkable conference and 
understanding, again, all of these initiatives that, honest to 
goodness, Congressman, I wasn't very well aware of, so maybe 
you need to do more education to your republic. And it is 
wonderful to hear.
    I also would like to thank everyone very much for the 
comments that people have made before over our study, the 
Indianapolis-Ibadan Dementia Project, which I have been 
principal investigator of originally, but I am not now the 
principal investigator, but still involved. And that is what I 
wanted to talk about today. I thought maybe my best 
contribution will be to try to bring you through some of the 
evolution of this particular project. It will show you how 
these comparative global studies can be very influential in 
identifying, potentially modifying risk factors, the surprises 
we sometimes come up with, and the challenges that you have to 
make them.
    Now, I did put with the testimony the outline of the 
project. Alas, when we went through all of the various 
iterations, it became very tiny and it required a great effort 
to read the little comments. So your staff member kindly put it 
on up on the screen. And if that is okay with Chairman Smith, I 
could go ahead and very quickly go over the findings.
    So, again, you have heard about all of this before. 
Comparing rates of illness between countries or communities can 
be very informative. You can compare risk factors then for the 
illness. And the benefits of the international studies 
developing in developed countries is it produces huge 
diversity. So you can look at much, much different environments 
than you can if you are just concentrating on one country.
    Our first venture actually was not in Africa but with the 
Cree, elderly Cree, in Manitoba, a place where I practiced 
before. But during the course of this study, we met a very 
remarkable man, and that was Professor Ben Osuntokun, who was 
from the University of Ibadan in Nigeria. And he came over to 
study with us for a year, in the process of this study. And the 
Indianapolis-Ibadan project is his idea. And I wish I could 
take credit for it, but it was his.
    And so, what he said was--now I can't even read it on 
there. Oh, well, we tried our best. There are versions of it 
that are bigger on the table.
    But what he said was, he had information from his 
population in Nigeria, Yoruba, from autopsy studies he had 
done, that he didn't think Alzheimer's disease occurred in the 
Yoruba because of a lack of plaques and tangles in the brain 
and so on.
    So what he proposed was a kind of unique thing. He said, 
why don't we do a classical migrant study? We will look at the 
Africans living in Ibadan, Nigeria, which is in West Africa, 
and we will look at the migrant population. That is where most 
of the African-Americans came from as part of the slave trade, 
of course, that came over from West Africa--not all were 
Yoruba--and were in the various communities.
    So we sat down and we wrote the Indianapolis-Ibadan 
project. We would look at large numbers of community-dwelling 
elderly people in Ibadan and large numbers of elderly African-
Americans living in Indianapolis. And that is what we have been 
following for the past 20 years. And over that period of time, 
we have seen over 4,000 people at each side over a long period 
of time.
    So what did we find? Well, the first thing we found was Dr. 
Osuntokun was wrong, that Alzheimer's disease was, indeed, 
present in Yoruba, and Alzheimer's disease was producing 
serious, significant defects for the families. The families 
were in great distress because of the behavioral symptoms that 
have been described before by Daisy Acosta. But the rates were 
lower in Yoruba at that time than the rates in African-
Americans.
    I should be very cautious about this. When we compare them 
with all of the rates of all the different countries in the 
world that have been published, they weren't out of the 
boundaries. So that the Yoruba were at the lower level of 
rates, the African-Americans were at the higher level, but they 
were all within the ballpark. There was nothing new.
    But the other thing that was surprising about this or was 
interesting about this was, it wasn't just rates of Alzheimer's 
disease that were lower; rates of diseases which are considered 
risk factors for heart disease were also lower, so lower rates 
of hypertension, lower rates of diabetes, lower rates of 
stroke. Actually, at that time, they were skinnier, their BMI 
was lower. The few studies we did of cholesterol levels showed 
that cholesterol levels were also lower. And there are a lot of 
different lifestyle factors involved with that, particularly 
diet. And we can talk about the diet issues later.
    So we were excited about that, and we thought there was 
clearly a connection between the heart and brain. That was 
relatively new at the time we talked about it, but now it is, 
as you see, pretty well-established. In fact, I think Bill 
Thies once said, ``What is good for the heart is good for the 
brain,'' which was a nice way to summarize the information.
    So what we planned to do at that stage was we would 
increase the intensity of looking at risk factors for heart 
disease in our populations. So we would do biomarkers, 
diseases, and so on, biomarkers of lipids and inflammatory 
markers and so on.
    But then what we were confronted with was the genetic 
explosion. All of a sudden, a huge amount of information became 
available in genetics. First of all, they found this remarkable 
finding that this form of a gene, APoE-e4, increased the risk 
dramatically for Alzheimer's disease. Not just in the United 
States but in almost any other country that we measured, there 
was almost no exceptions to the rule that e4 increased the 
disease.
    And then, for us, even maybe a more exciting finding from 
the population geneticists, the population geneticists then 
said, maybe the anthropologists are right, that it looks as if 
modern human beings arose in Africa and migrated not terribly 
long ago, about 150,000, 200,000 years ago. So that if you want 
to study chronic illness, the likelihood is that all of the 
genes for chronic illness were present in the African 
population, and you should try to incorporate the African 
population when you are studying the genesis of chronic illness 
throughout the world, including Alzheimer's disease, which made 
us, of course, very happy. And we incorporated, then, into our 
study a large genetic component, as well as the biomarker 
component that we talked about before in the risk factors.
    So, building upon that, we said, well, we are going to look 
at the biomarkers for cardiovascular disease, and we are going 
to look at the genetics of Alzheimer's disease, and we are 
going to look particularly at those genes that people had 
picked out, the APoE-e4 and so on, that were big risk factors. 
And this is the model we were going to use.
    If you really want to understand Alzheimer's disease rates 
in any community, you would have to look at both. You look at 
genetics, look at environmental factors, and, even more 
importantly, see how they interact with each other. And if I 
had to bet what is going to happen in research in the next 10, 
15 years--it is already happening--is how do genes and the 
environmental factor interact and alter gene function in the 
process and may produce illness.
    So what did we find? Very quickly, well, with the 
biomarkers, some surprises, but some not. So when we looked at 
all of the cholesterol levels, the lipid levels, and so on, 
they were lower in Yoruba than they were in the African-
Americans--not surprising because of their diet. Surprising 
that one-quarter of African-Americans were now on statins. Even 
with the statins, there were still lower levels in Yoruba.
    And, by the way, in 1991 when we started, the number of 
African-Americans on statins was almost zero. In 2001, when we 
did that, a quarter of the population were now taking statins--
a very dramatic increase.
    But some surprises, like we would have thought oxidative 
stress would be lower in the Yoruba than it is in African-
Americans because of the diet again. It wasn't. The measures of 
oxidatives were higher in the Yoruba. So it is sometimes very 
puzzling. Inflammatory markers were just as common in the 
Yoruba as the African-Americans. So one of the nice things to 
think about research and this kind of research is it often 
gives you unusual results that allow you to explore it further.
    So the big finding when you put everything together was 
APoE-e4, the big risk factor for almost the rest of the world, 
was not a risk factor for the Yoruba--not a risk factor for 
dementia, not a risk factor for Alzheimer's disease, not a risk 
familiar for cognitive decline, not a risk factor for 
mortality--whereas it was in the African-American population 
and most of the other populations.
    And some of the other findings--you mentioned hypertension, 
for instance. That is one of the nice things I think you can do 
when you look at different populations--a little sad, in a way, 
because the Yoruba population, alas, doesn't get the treatment 
for hypertension that we get in our country. And, in fact, now 
it looks as if hypertension in old people is definitely a risk 
for dementia in Nigerians, and once they get above systolic 
levels of 160 or so on, they ought to be treated. And that 
information is now being conveyed to the faculty and group at 
the university hospital.
    But, again, a surprise was, when we looked at the lipids, 
there was an interaction between lipids and--you couldn't 
understand the effects of the lipids without taking into 
consideration APoE-e4. So there was some interaction between 
the both of them. If you added APoE-e4, lipid levels didn't 
make any difference in the two communities. If you didn't add 
APoE-e4, lipid levels when they rose increased the risk for 
dementia. So that made us puzzle, is there some sort of link 
between e4 and lipid levels, and could this explain some of the 
differences in the communities?
    So one of the things we are going to now look at is we are 
trying to figure out what is going on. And one of the things 
going on is that there may be--if e4 is not a risk, there may 
be other genes that are present that are much more easily 
identifiable in Nigerians because they are not overwhelmed by 
the e4 risk. There may be gene clusters that protect against e4 
that is particularly seen in the Nigerian population but it 
would also be seen in others. And, again, as we said, the 
environmental factors may result in alterations in gene 
function.
    And at the moment what we are doing is we are now expanding 
the GWAS studies that Dr. Hodes talked about before, both for 
the African-Americans and for the Nigerians, looking at their 
generic structure to make new associations. We hope, by 
combining that genetic information with all of the information 
we have available at the moment, we will be able to come up 
with better models of the disease.
    Thank you.
    [The prepared statement of Dr. Hendrie follows:]

    
    
    
    
    
    
    
    
    
    
    
    
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    Mr. Smith. Dr. Hendrie, thank you very much.
    I would just say to my colleagues that I have been advised 
that we will have a series of votes that will last for well 
over an hour, beginning around 4:10, 4:20. We would need to 
leave here by about 4:20 or so. So I thought what we might all 
do, if it is okay, is just, we will all ask our questions, and 
if you don't just mind then responding just so that everyone 
gets an opportunity to pose.
    I will ask just a couple. Dr. Frisoni talked about the 
research not being coordinated. It is detached, to use his 
words. If you could maybe speak to what kind of prioritization 
you think other countries are doing. You know, if any of you 
would want to--perhaps, Dr. Acosta, you would be the one.
    What countries are doing the best? Is it the U.K.? Is it 
some other country? You know, a list of, perhaps, some of those 
countries. Have WHO, PAHO, and other regional health bodies 
prioritized Alzheimer's sufficiently well, or are we in the 
beginning stages of getting them to embrace it?
    Mr. Vradenburg, you talked very eloquently about bringing 
members of the Treasury Department and others. Maybe others 
might want to respond to that, because I think the fiscal 
crisis parallels the health crisis. And if we underestimate 
CBO, CMS, and all the other agencies that do numbers-crunching, 
they will miss by a mile the impact, the devastating impact, 
that Alzheimer's will have.
    And, Dr. Cummings, when you talked about all of the risk 
factors, since Africa has disproportionately suffered so much 
trauma--you mentioned DR Congo, 4 million dead due to its wars, 
ongoing violence against women and all people--is there any 
indication that that is now manifesting in additional cases of 
Alzheimer's going forward?
    I do have a lot of other questions, like about effective 
drugs, but in the interest of my colleagues, I would like to 
yield to Mr. Payne, Mr. Marino, who was here and I am sure will 
be back, Mr. Connolly, and certainly a good friend and 
colleague, Mr. Markey.
    Please.
    Mr. Connolly. Mr. Markey has switched sides, obviously.
    Mr. Smith. He has seen the light.
    Mr. Payne. When I was listening to your comments, Dr. 
Vradenburg, about the people living to be 110, 120, I was 
cringing when I thought maybe Mr. Ryan would hear about these 
numbers and we would be in pretty bad shape.
    Let me just ask regarding the studies, Dr. Hendrie--very 
interesting. And the majority of studies on dementia were 
conducted in the developed world, but, as you mentioned, 
estimates of the prevalence of dementia in sub-Saharan Africa 
are based on limited and dated studies. Your research was a few 
years ago, and conducted involving Nigeria--still a key source 
of information.
    And do you know, actually, about the prevalence of 
Alzheimer's in Africa? Has it increased?
    In your opinion, what are the greatest challenges in 
conducting Alzheimer's prevalence studies in the developing 
world? And what might you expect? I expect that we can focus 
more attention on these studies that were conducted before we 
can sort of rev it up again.
    I have a number of questions, but let me just stop there. 
If there is time left, then we could ask another question. But 
I will just end there, and we can just let other members----
    Mr. Smith. Mr. Markey?
    Mr. Markey. Thank you so much.
    And thank you all for your excellent testimony.
    Dr. Cummings, you have worked to expand the use of brain 
imaging and biomarker technologies to allow Alzheimer's to be 
diagnosed earlier than before. How do we get more people in the 
United States and abroad involved in these modern scans to 
detect plaques and tangles in the brain before they show up as 
symptoms?
    Mr. Smith. And Mr. Connolly?
    Mr. Connolly. Thank you, Mr. Chairman.
    And thank you for letting me participate in the 
subcommittee. I am here because I bumped into Daisy Acosta and 
my friend George Vradenburg in the cafeteria, and I was not 
aware of the fact you were having this hearing. And I think it 
is a very important hearing. Sooner or later, Alzheimer's 
touches everybody's life.
    And maybe I could put a question to Mr. Vradenburg, and 
that is if you might comment on, where are we from 
USAgainstAlzheimer's point of view and other advocates in terms 
of research dollars in the United States? And are they going to 
the right kinds of research, in terms of efficacy?
    Thank you, Mr. Chairman.
    Mr. Smith. Please proceed.
    And, Dr. Frisoni, if you wanted to chime in and answer any 
of the questions, please jump in.
    Mr. Vradenburg. Let me quickly respond to a couple of 
those.
    Has WHO prioritized Alzheimer's? The answer is no. They 
have one person who has a--John Beard, you mentioned him--a 
Life Course and Ageing portfolio. They do not have any resource 
applied to studying the incidence or prevalence of this disease 
or how to treat it at WHO. And, indeed, they have reached out 
for private resources, including mine, to help them finance a 
study at WHO. If my mother were alive and I told her that the 
World Health Organization at the United Nations was coming to 
me for finance on how to figure out a study on this problem, 
she would be surprised.
    CBO and OMB will miss this by a mile, you are absolutely 
right. We do think short term in this country. If, in fact, you 
talk the word ``investment'' right now, if you can't show a 
return within a year, you are having a hard time crossing any 
of the hurdle rates.
    So, in fact, you know, arguing for additional resource to 
NIH, or to NIA in particular, is a very hard lift, even though 
you could say, just by looking at historic examples, investment 
makes a difference. As Dr. Thies pointed out, $6 billion for 
cancer and $4 billion for heart and $3 billion for AIDS and 
$450 million for Alzheimer's.
    The death rates: Cancer going down, generally, not across 
the board, but generally; heart death rates going down. Indeed, 
heart used to be the highest cost to Medicare; it is now 14th 
in cost. HIV/AIDS has gone from 60,000, 70,000, 80,000 people 
dying a year to 10,000. Its cost is now not even in the top 
15--or the mortality is not even in the top 15. A hundred 
billion dollars invested in HIV/AIDS research saved us $1.4 
trillion in terms of costs. But those things would not have 
been scored by CBO or OMB.
    To your point, Mr. Connolly, there is absolutely no 
question that this aging phenomenon has overcome us, in terms 
of our research portfolio. We invested in a lot of the diseases 
that were--the war on cancer was 1971, the efforts against 
heart were in the 1980s-1970s, HIV/AIDS was 1980s to 1990s. 
Alzheimer's has sort of come too late in the public and 
political consciousness to catch up to those diseases, in terms 
of our investment. As a consequence, we are way underinvested 
in terms of the aging agenda and the Alzheimer's agenda.
    Mr. Hall. If I may with some of these other disease states 
that we talked about, the funding came about because there was 
a cry from the people who were impacted by these diseases and 
thereby really sort of forced everyone's hand to sort of move.
    The problem we have with our population is that the people 
with the disease are unable to speak for themselves, so you are 
not going to have a rally of the 5 million here in DC, of them 
gathering. And, additionally, you are not going to have even 
their families who are impacted rallying, as well, with such 
enormous numbers to really push the agenda, because they are 
engaged 24/7 in the care of the population, the care of their 
loved one with the disease.
    With these other countries that have designed their own 
Alzheimer's project acts and have put together a plan and moved 
it forward, the ones that have been most successful, in my 
estimation, are the ones that have really strong political 
resolve to get it done.
    And it really takes leadership, enormous leadership, to 
push this disease, especially when you are not going to have 
that large of a cry from constituents, you know, to say that 
this needs to get done, because they are not able to rally. 
But, at the same time, based on everything that you have heard 
here and things that we have heard for years before this 
meeting, as well, about the growing population, it really does 
take enormous political resolve to get this done.
    Dr. Acosta. I think that by history the World Health 
Organization and most health systems in all governments in all 
countries pay more attention to illnesses who have a higher 
burden on mortality than on disability. But that is definitely 
changing, because now the most common cause of ill health are 
chronic illnesses. The WHO had launched the MHA guide last 
October, and they developed packages of cure for different 
chronic illnesses. Dementia was one of those seven illnesses.
    So I really do encourage all of you to take a look at all 
of those packages of care when you are developing your national 
plan because they are set for different countries, a different 
level according to the budget of each country. I think it is 
very important.
    Dr. Cummings. You asked about other countries and were 
other countries getting it right. A few examples that I think 
are important. President Sarkozy will come to the ICAD meeting 
in July and address us, and he really gets it about Alzheimer's 
disease. I think he understands the importance. He has 
championed that in the European Commission as well as in 
France.
    The Queen Sofia Alzheimer's Disease Center in Madrid I 
think is a centerpiece for Alzheimer's disease care, and she is 
trying to proliferate that in other cities in Spain. Both Italy 
and Germany have made new recent progress in terms of creating 
Alzheimer's disease centers throughout their countries.
    So I think we have done a lot, and the NIA program, the 
other programs you have heard about are terrific. There is more 
to be done, and there is a lot to be learned from other 
countries.
    Dr. Hendrie. I would like to respond to Congressman Payne's 
questions about frequency of Alzheimer's disease in Africa. 
Just a couple of things about our own study. When we do studies 
here, we like to get what we call representative samples. So we 
will look over the population, like our African-Americans in 
Indianapolis, who are representative of African-Americans 
throughout our State of Indiana. You can't do that in Africa 
because we don't have a good enough census. So what you do is 
you take one particular district or area, and then you try to 
make sure you see every person in the area, which is a very 
good way to do it, but it means you can't generalize. So we 
can't say from our study what it would be like in other parts 
of Africa or even other Yoruba communities. There hasn't been 
any really--one other thing about our study is that we saw this 
link between hypertension and diabetes. In 20 years since we 
started the study, our data and the data from other studies 
looking at hypertension in middle-aged people all come to the 
same conclusion. It is increasing dramatically in Nigeria and 
increasing dramatically probably in Africa. And if it is 
increasing dramatically, then I would bet a lot of money that 
Alzheimer's disease and other dementing disorders are also 
going to increase rapidly.
    There have been a few other pilot studies. There was one 
very big study done in Egypt which came up with results very 
similar to the Europeans. Pilot studies in Kenya that we did 
and in Benin, and so on, came up with rates roughly comparable 
with ours, but relatively small populations. So rates that we 
had are the low estimate. And in the near future they are going 
to go up.
    Mr. Smith. Yes.
    Dr. Frisoni. Mr. Chairman, may I add a comment?
    Mr. Smith. Please do, Dr. Frisoni.
    Dr. Frisoni. Okay. Thank you. It seems to me that clearly 
Alzheimer's is a global challenge that requires a global 
answer. These are times when funding agencies are short of 
money, and things may not improve dramatically in the 
foreseeable future. It seems to me from what has been said by a 
number of speakers that there are three levels of coordination 
that we can envision, coordination at the level of funding 
research, coordination at the level of doing research, and 
coordination at the level of applying the results of research.
    Now, the second level, the level of doing research, is the 
coordination among scientists, and is very good. The AAIC, the 
international meeting on Alzheimer's has been repeatedly 
mentioned. And that is a place where scientists from all over 
the world align their ideas, align their minds.
    Coordination at the level of applying the results of 
research has been mentioned as an area that requires more 
coordination. What I have tried to advocate with my testimony 
is the increased coordination at the level of funding research. 
In Europe, there is awareness that countries, member countries, 
so-called member countries of the European Union, must fully 
join forces. But that will not be enough. Joined forces among 
European members will not be enough. I suspect, I strongly 
believe that it will be necessary to join forces between all 
Europe and the U.S.--at least to start with--at the level of 
funding agencies, with coordination.
    There is an initiative of the European Parliament to 
develop a directorate to coordinate research across the 
Atlantic. I believe that this is definitely a big challenge. It 
is a huge challenge. But it is something that is worth trying.
    Mr. Smith. Dr. Frisoni, thank you so much. We only have 
about 13 or 14 minutes left. We do have to report for a vote. 
But Dr. Thies.
    Mr. Thies. I would like to say there are two major barriers 
to progress in Alzheimer's disease. There is clearly not enough 
money for basic research, and probably we could improve that by 
coordinating it with other countries.
    The second biggest barrier is not enough people in clinical 
trials. And while I am very unwilling to correct Dr. Cummings, 
there is a national recruiting program for Alzheimer's trials 
called TrialMatch. You can access it at ALZ.org or at our 800 
number.
    Mr. Smith. Dr. Cummings and then Dr. Acosta.
    Dr. Acosta. I wanted to address Congressman Markey's 
question, even though he is not here. He asked how could we get 
more people into these scans? And I think that is a real 
problem. I think many doctors in the United States still 
believe that cognitive decline is normal in aging. We have an 
enormous educational hurdle ahead of us. One of the things we 
are trying to do is to develop an electronic medical record 
that will actually guide people through the dementia workup so 
that if they don't understand how to do this they could open up 
an application, maybe it could even be a phone app, and it 
would guide them through what a good mental status examination 
and diagnostic workup would be.
    So I think we can look to technology to advance us in some 
of these fields. But again we are still at a relatively 
primitive level, and we have an enormous hurdle ahead of us for 
detection of Alzheimer's disease.
    Mr. Smith. Thank you. Dr. Acosta.
    Dr. Acosta. I don't want you to think of people with 
dementia as people who cannot have an input in helping you do 
what you want do. So it is important for you get the consumers' 
perspective, to include them into their opinions. We have a 
board member with dementia, and they are excellent in giving us 
and leading our work.
    Mr. Smith. Dr. Vradenburg?
    Mr. Vradenburg. Mr. Chairman, I would urge you to consider 
the creation of a national goal to stop--by stop I mean prevent 
or control Alzheimer's--by 2020. By setting a national goal, 
you will mobilize the resources necessary to do it. You will 
force a reexamination of the systems which are impeding the 
speed at which these developments occur, whether it is basic 
research, translational research, clinical trial development, 
or regulatory processes that themselves are sluggish. Capital 
is leaving this market because of the length and time of the 
cost and time to get to market. And researchers are not going 
to cure this disease. They may find pathways, but it will be 
companies that will invest in the drug treatments and other 
treatments necessary to cure this disease. By setting a 
national goal, you will mobilize the resources and you will 
examine the processes that are slowing or making sluggish our 
path to a solution.
    Right now we are building more nursing homes and we are 
building more care facilities, which is the equivalent of 
building an iron lung and leg brace industry. And we can think 
of that as jobs, jobs, jobs, but cures will drive economic 
growth.
    So I would urge your consideration, Mr. Smith, of adopting 
a national goal in this area.
    Mr. Smith. Excellent idea. Thank you very much, Mr. 
Vradenburg.
    Dr. Acosta, could I just ask you briefly, Dr. Hodes said 
earlier that with adequate funding, twice as many outstanding 
research proposals could be resourced. What is the sense of 
what is happening in other countries? And anyone who would like 
to address this as well. Are they getting laudable proposals 
that are falling off the table? And we have not spoken at any 
length about what is happening in Central and South America. 
How prioritized is combating Alzheimer's disease south of the 
border?
    Dr. Acosta. Definitely not prioritized at all. I think you 
should set the example. And I am not kidding about this. I will 
just give you an anecdote. It was very hard for me to get an 
appointment with our first lady in the Dominican Republic in 
order for me to propose to them a national plan. The first 
thing I was asked was what is the United States doing? I said 
they are working on it. I was never called back again.
    So I think you have an enormous duty not only with the 
United States, but also with other developing countries.
    Mr. Smith. Thank you.
    Mr. Thies. I would just comment on the grant question. We 
just finished our funding for this year, and we will be at 
about the same stage as NIA. We probably will fund a little 
over 10 percent of the grants that come to us. I think Dr. 
Hodes is being characteristically conservative when he says 
double. I think it is three or four times, with really 
meritorious projects, and projects that would contribute 
significantly.
    And as a follow-on to George's comment about the 
development of real medications, those do depend on the 
corporate sector. And we don't really have any representatives 
of that sector here.
    Actually, I came from another meeting which is going on on 
the other side of Washington, which is academic scientists, 
corporate scientists, and regulators that are talking about 
particular barriers for making progress. We have an interest in 
investing in Alzheimer's disease treatments from the corporate 
sector. They don't have enough new ideas, and they don't have 
certain types of technical ideas, and the reason they don't is 
that we just don't have the money to fund those.
    Mr. Hall. It is quite appropriate that the conversation 
here goes toward a discussion about research for treatments and 
a cure. Ultimately, that is what we all want. I would simply 
ask in the conversation going forward that we really need to 
stay also focused on families and their needs. The care giving 
burden is left to the family. There are needs for programs and 
services and some level of support. All the families I have met 
from coast to coast are not asking for anyone to do their work 
or their job for them. They fully accept their responsibility. 
They are simply asking for some help along the way. And so as 
much as we are focusing on research and cure, I would really 
like to focus on the role of the caregiver and supporting care 
giving as well.
    Mr. Smith. Mr. Payne.
    Mr. Payne. Yeah, and actually in the 1960s and 1970s, when 
cancer started to be noticed, they had all kind of assistance 
for families, if you lived in the right place, to help pay your 
mortgage, et cetera, and so forth.
    It seems to me that Alzheimer's, you know, if we could get 
a goal, it seems like it is a disease that impacts many people. 
And if there can be a profit. You know, we never saw much work 
on malaria because, well, even if they found the cure, the 
people that get it can't pay for it, so no incentive for a 
company to go look at a cure for malaria. But it seems like 
Alzheimer's, since it is so predominant across all countries, 
it seems like that would be financial incentive to these 
companies to do research.
    And the other thing too, Dr. Hendrie, and I probably won't 
even have time for an answer, but what about the Western diet 
that has been introduced into say Africa, for example, or 
probably even China? You know, people were eating what was 
available, grains, maybe soy stuff, things that were more 
healthy I guess. Well, now they have become Westernized, and a 
lot of advertisement about eating what we eat, and so things 
like diabetes, or seems like those kinds of Western diseases 
are going to be introduced. Do you think that is a possibility?
    Dr. Hendrie. Just very quickly, I do think that. It is very 
hard to know the extent in the relatively poor people we are 
studying just now. But I think there are more processed foods 
than were available before. You know, it used to be called the 
Nigerian paradox that in our country hypertension occurs most 
commonly in poorer people. In Nigeria, it occurred most 
commonly in richer people. And why was that? Because they were 
able to buy processed foods and foods that were heavily salted 
and so on. Now, whether that is true or not now, I don't know. 
But the change in diet I think is certainly going to be 
significant.
    Mr. Smith. Sadly, we are out of time. There are nine votes 
pending on the House floor. I do want to thank our august 
panel. You have been extraordinary. Your recommendations are 
all actionable. And I can assure you this subcommittee will do 
everything possible, and, with Mr. Markey joining on the Energy 
and Commerce Committee and others, I think we can be very 
successful. At least we will try.
    Without objection, I would like to include a report on a 
high level seminar at the European Parliament from January 26, 
2011. A couple weeks ago I met with a member of the European 
Parliament, Mario Mauro. I will meet him next week in Brussels 
and talk further about how we can collaborate with our friends 
in the European Parliament as well as at the OSCE and other 
bodies where we can all work together on combating Alzheimer's. 
Dr. Frisoni, thank you so much for joining us. And without 
further adieu, the hearing is adjourned.
    [Whereupon, at 4:30 p.m., the subcommittee was adjourned.]
                                     

                                     

                            A P P E N D I X

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   Material submitted for the record by the Honorable Christopher H. 
 Smith, a Representative in Congress from the State of New Jersey, and 
   chairman, Subcommittee on Africa, Global Health, and Human Rights











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