[Senate Hearing 108-715]
[From the U.S. Government Publishing Office]
S. Hrg. 108-715
ALZHEIMER'S DISEASE RESEARCH
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
MARCH 23, 2004--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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__________
COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
SAM BROWNBACK, Kansas MARY L. LANDRIEU, Louisiana
James W. Morhard, Staff Director
Lisa Sutherland, Deputy Staff Director
Terrence E. Sauvain, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas HARRY REID, Nevada
TED STEVENS, Alaska HERB KOHL, Wisconsin
MIKE DeWINE, Ohio PATTY MURRAY, Washington
RICHARD C. SHELBY, Alabama MARY L. LANDRIEU, Louisiana
ROBERT C. BYRD, West Virginia (Ex
officio)
Professional Staff
Bettilou Taylor
Jim Sourwine
Mark Laisch
Sudip Shrikant Parikh
Candice Rogers
Ellen Murray (Minority)
Erik Fatemi (Minority)
Adrienne Hallett (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
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Page
Opening statement of Senator Mike DeWine......................... 1
Prepared statement........................................... 2
Statement of Dr. Richard J. Hodes, Director, National Institute
on Aging, National Institutes of Health, Department of Health
and Human Services............................................. 3
Prepared statement........................................... 6
Statement of Johnny Orr, husband of Alzheimer's patient, West Des
Moines, IA..................................................... 11
Summary statement of Romie Orr................................... 12
Prepared statement of Johnny Orr................................. 13
Statement of Dennis Kroucik, Alzheimer's patient, Elryia, OH..... 14
Prepared statement........................................... 15
Statement of Shelley Fabares, national board member, Alzheimer's
Association, Studio City, CA................................... 16
Prepared statement........................................... 18
Statement of Sheldon Goldberg, president and CEO, Alzheimer's
Association, Chicago, IL....................................... 19
Prepared statement........................................... 21
Statement of Dr. David Snowden, professor in the Department of
Neurology and the Sanders-Brown Center on Aging at the
University of Kentucky, Lexington, KY.......................... 23
Prepared statement........................................... 25
Statement of Senator Tom Harkin.................................. 27
Prepared statement of Senator Mary L. Landrieu................... 35
Prepared statement of Phyllis Campbell, president, Urban League
of Lancaster County, Pennsylvania.............................. 36
Questions submitted by Senator Mary L. Landrieu.................. 37
ALZHEIMER'S DISEASE RESEARCH
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THURSDAY, MARCH 23, 2004
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:33 a.m., in room SD-G50, Dirksen
Senate Office Building, Hon. Mike DeWine presiding.
Present: Senators DeWine and Harkin.
OPENING STATEMENT OF SENATOR MIKE DE WINE
Senator DeWine. Good morning. This morning I would like to
welcome the members of the Alzheimer's Association and to
congratulate all of you on the tremendous progress that you
have made in the prevention, diagnosis, and treatment of
Alzheimer's disease. We are pleased to be part of your 16th
Public Policy Forum and to kick-off your Capitol Hill Day with
this hearing this morning.
We are honored to have before the subcommittee a
distinguished panel of scientists, advocates and patients to
discuss Alzheimer's disease. Senator Arlen Specter wanted me to
express his regret that he has a scheduling conflict and may be
joining us a little later today. He wanted me to convey to you
his appreciation for your tireless efforts, tireless efforts on
behalf of Alzheimer's patients and certainly their families.
In our Nation today there are approximately 4.5 million
Americans with Alzheimer's disease. In addition to the
unbelievable human cost, there is, of course, the economic
cost, a cost of over $100 billion every year. For years
scientists have been predicting that the number of individuals
with the disease will steadily rise and now a recent study in
dictates that the Alzheimer's epidemic will be even worse than
previously thought. The study predicts the prevalence of
Alzheimer's disease will increase 27 percent by the year 2020,
70 percent by 2030 and nearly 300 percent by 2050, when as many
as 16 million Americans could be stricken. If these predictions
become a reality scientists agree the disease could destroy our
health care system and bankrupt Medicare and Medicaid, not to
mention what this will do to our families. In my home State of
Ohio alone there are approximately 212,000 people with
Alzheimer's disease today. Based on population growth, unless
science finds a way to prevent or delay the onset of this
disease that number will skyrocket to 308,000 by the year 2025.
PREPARED STATEMENT
The Federal Government's involvement in Alzheimer's disease
research began in 1976, when three of the Institutes at the
National Institutes of Health invested a total of $3.8 million
in research into finding the cause of the disease. Today, 19
Institutes have Alzheimer's projects as part of their research
agenda and it is projected that $698.9 million will be spent on
the disease in fiscal year 2005. The National Institute on
Aging funds a network of approximately 30 Alzheimer's disease
research centers around the country, one of which is operated
by Case Western Reserve University Hospitals of Cleveland. The
$6.5 billion that the Federal Government has invested in
Alzheimer's disease research over the past 29 years has
resulted in tremendous progress. We have seen great
improvements in diagnostic tools that can help providers
diagnose the disease with more than 90 percent accuracy. Genes
have been identified that may put people at increased risk for
developing Alzheimer's disease and medications are now
available that can help to alleviate the symptoms of disease.
This subcommittee is proud of our investment in Alzheimer's
research. These funds are not only important for our loved ones
but are a critical investment in the future of America.
[The statement follows:]
Prepared Statement of Senator Mike DeWine
The Subcommittee will come to order. This morning I would like to
welcome the members of the Alzheimer's Association and congratulate you
on the tremendous progress that you have made in the prevention,
diagnosis, and treatment of Alzheimer's disease. I am pleased to be a
part of your 16th public policy forum and to kick off your Capitol Hill
Day with this hearing.
We are honored to have before the Subcommittee a distinguished
panel of scientists, advocates, and patients to discuss Alzheimer's
disease. Senator Specter wanted me to express his regret that he has a
scheduling conflict and may be joining us a little later. He wanted me
to convey to you his appreciation for your tireless efforts on behalf
of Alzheimer's patients and their families.
In our Nation today, there are approximately 4.5 million Americans
with Alzheimer's disease, costing the economy over $100 billion
annually. For years, scientists have been predicting that the number of
individuals with the disease will steadily rise. And now, a recent
study indicates that an Alzheimer's epidemic will be even worse than
previously thought. The study predicts the prevalence of Alzheimer's
disease will increase 27 percent by 2020, 70 percent by 2030, and
nearly 300 percent by 2050, when as many as 16 million Americans will
be stricken. If these predictions become a reality, scientists agree
that the disease could easily destroy our health care system and
bankrupt Medicare and Medicaid.
In my home state of Ohio, alone, there are approximately 212,000
people with Alzheimer's disease. Based on population growth, unless
science finds a way to prevent or delay the onset of this disease, that
number will skyrocket to 308,000 by 2025!
The federal government's involvement in Alzheimer's disease
research began in 1976 when three of the Institutes at the National
Institutes of Health invested a total of $3.8 million in research into
finding the cause of the disease. Today, 19 Institutes have Alzheimer's
projects as part of their research agenda, and it is projected that
$698.9 million will be spent on the disease in fiscal year 2005. The
National Institute on Aging funds a network of approximately 30
Alzheimer's disease research centers around the country, one of which
is operated by Case Western Reserve University/University Hospitals of
Cleveland.
The $6.5 billion that the federal government has invested in
Alzheimer's disease research over the past 29 years has resulted in
tremendous progress. We have seen great improvements in diagnostic
tools that can help providers diagnose the disease with more than 90
percent accuracy. Genes have been identified that may put people at
increased risk for developing Alzheimer's disease. And, medications are
now available that can help to alleviate the symptoms of disease.
This Subcommittee is proud of our investment in Alzheimer's. These
funds are not only important for our loved ones, but are a critical
investment in the future of America.
STATEMENT OF DR. RICHARD J. HODES, DIRECTOR, NATIONAL
INSTITUTE ON AGING, NATIONAL INSTITUTES OF
HEALTH, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Senator DeWine. This subcommittee is now pleased to hear
from our first witness. Dr. Richard Hodes is the Director of
the National Institute on Aging at the National Institutes of
Health. Since 1993, Dr. Hodes has served as the Director of the
National Institute on Aging. He has also held several other
posts at the NIH, including clinical investigator at the
National Cancer Institute, a program coordinator for the U.S.-
Japan Cooperative Cancer Research Program and Deputy Chief of
the Cancer Institute's Immunology Branch. He is a graduate of
Yale University and received his M.D. from Harvard Medical
School.
Doctor, thank you very much for joining us and you may
proceed.
Dr. Hodes. Senator DeWine, thank you for the opportunity to
join this hearing on Alzheimer's disease, a topic of great
interest and concern to us all. You have well summarized the
burden that Alzheimer's provides and presents to individuals,
to families, to the health care system and in fact to society
as a whole. Fortunately, these stark numbers do not tell the
whole story and in fact the progress in Alzheimer's research
offers promise to develop effective methods of treatment, to
delay, ultimately to prevent Alzheimer's disease.
Research from the laboratory, from clinical studies, from
epidemiologic studies have continued to point towards clues of
the underlying risk factors for Alzheimer's disease. We know
that age is an outstanding example of these risk factors such
that by age 85 and older nearly half of the individuals at that
age will be affected. Understanding who is at high risk, who is
not and why, is a critical aspect of identifying the process
and developing means to intervene to alter it. We understand at
the level of genetics a number of genes which cause early-onset
of familial Alzheimer's disease and we've begun to learn more
about those genes which are involved in the more common late-
onset examples of Alzheimer's disease. A year ago we mentioned
an Alzheimer's disease Genetics Initiative and I'm pleased to
report this year that initiative is well underway. The National
Institute on Aging, together with the very critical
collaboration of the Alzheimer's Association and dedicated
patients and their families have moved significantly towards
the goal of accruing a larger number of individuals necessary
to identify genes, understand risk factors and develop new
targets for intervention.
DIABETES
In an effort to understand modifiable risk factors for
Alzheimer's disease, it has been determined that diabetes, a
condition which affects some 17 million Americans, increases
the risk of dementia. It appears, however, from a recent study
that, among older women with diabetes, those who have had
treatment to control glucose have a decreased risk of
Alzheimer's disease and so NIA-supported investigators working
with the National Heart, Lung and Blood Institute's Action to
Control Cardiovascular Risk in Diabetes (ACCORD) study, are
looking to determine whether aggressive treatment to control
blood sugar will effectively prevent Alzheimer's disease in
individuals with diabetes.
NEUROIMAGING
Brain imaging has been a modality that's been critical in
providing a window to the brain, understanding both structure
and function, the changes which precede and accompany
Alzheimer's disease. However, until recently we have been
unable to actually image the lesion specific to Alzheimer's. In
the past year there has been a report of a very important
element of progress toward this end, illustrated in the first
slide displayed on the screen here.
This is the result of studies identifying a novel tracer
called Pittsburgh Compound B that appears to bind specifically
to and therefore can help imaging of the amyloid lesions in the
brain. The ability to identify such lesions will allow for
earlier diagnosis and if this application proves to be valid,
in fact may allow us to monitor the course of interventions
designed to treat and even prevent disease.
We talked a year ago about a Neuroimaging Initiative and
again I'm pleased to report that this Initiative is now well
underway with applications received under peer review and if
peer review is indeed positive with the ability to begin the
study within the current year. This is a really novel and
landmark collaboration; it involves NIH, the Food and Drug
Administration, the Center for Medicare and Medicaid Services,
private sector pharmaceutical industries and imaging industries
as well as the very important collaboration of the Alzheimer's
Association. Its goal is to identify imaging markers that will
allow early diagnosis of the disease and perhaps even more
importantly allow us to monitor the progress in response to
interventions, allowing us to more effectively, more rapidly
and more cost-effectively develop interventions to treat and
prevent disease.
The development of treatments for Alzheimer's disease is
based on clues that come from laboratory as well as
epidemiologic studies and among the examples of newer
approaches towards treating the lesions of Alzheimer's disease
is that illustrated in this next figure, which uses a very
important mouse model of Alzheimer's disease.
What's shown here in the middle panel, pointed to by the
arrow, is an example of the lesions, which are actually amyloid
plaques in this mouse model of Alzheimer's disease, distributed
in an area that's very similar to those which are seen in human
patients with the disease. And the panels to either side are
the result of expressing in these mice an increased level of
proteins, in one case insulin-degrading enzyme, the other
neprilysin, two naturally occurring compounds, and an example
of the in which natural defenses can be mobilized to decrease,
reverse, even prevent the accumulation of amyloid lesions. This
provides an example, a model for the way in which such
laboratory findings can be translated ultimately into
interventions for humans.
Finally, at the same time that we work towards developing
cures and prevention for Alzheimer's itself, we retain a focus
on the important population of care givers who take care of
those currently afflicted with Alzheimer's disease. And so a
clinical trial called REACH, Resources for Enhancing
Alzheimer's Care Giver Health, is targeted at helping the
status of care givers who all too often themselves suffer
emotionally, physically and economically and the outstanding
work they do to care for those with Alzheimer's.
PREPARED STATEMENT
It is not possible to be precise in predicting exactly
which of these research directions will most quickly produce
the final outcome we desire, treatment, delay and ultimately
prevention, but the pace of research summarized in some
examples here provides hope greater than ever before that we
will, in fact, find these interventions in time to spare many
from the affliction of Alzheimer's disease.
I again thank you for the opportunity to be here and
welcome any questions that you may have.
[The statement follows:]
Prepared Statement of Dr. Richard J. Hodes
Senator Specter and Members of the Committee: Thank you for
inviting me to appear before you today to discuss Alzheimer's disease
(AD), an issue of interest and concern to us all. I am Dr. Richard
Hodes, Director of the National Institute on Aging (NIA), the lead
federal agency for Alzheimer's disease research. I am delighted to be
here today to tell you about the progress we are making toward
understanding, treating, and preventing AD.
As you know, AD is a devastating condition with a profound impact
on individuals, families, the health care system, and society as a
whole. Approximately 4.5 million Americans are currently battling AD,
with annual costs for the disease estimated to exceed $100 billion.\1\
Moreover, the rapid aging of the American population threatens to
increase this burden significantly in the coming decades: Demographic
studies suggest that if current trends hold, the annual number of
incident cases of AD will begin to sharply increase around the year
2030, when all the baby boomers (born between 1946 and 1964) will be
over age 65. By the year 2050, the number of Americans with AD could
rise to some 13.2 million, an almost three-fold increase.\2\
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\1\ Data from the Alzheimer's Association. See also Ernst, RL; Hay,
JW. ``The U.S. Economic and Social Costs of Alzheimer's Disease
Revisited.'' American Journal of Public Health 1994; 84(8): 1261-1264.
This study cites figures based on 1991 data, which were updated in the
journal's press release to 1994 figures.
\2\ Hebert, LE; Scherr, PA; Bienias, JL; Bennett, DA; Evans, DA.
``Alzheimer Disease in the U.S. Population: Prevalence Estimates Using
the 2000 Census.'' Archives of Neurology August 2003; 60 (8): 1119-
1122.
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But these numbers, however stark, do not tell the whole story.
Although AD remains a major public health issue for the United States,
we have made, and are continuing to make, dramatic gains in our ability
to understand and diagnose AD that offer us the hope of preventing and
treating the disease, to reverse the current trends. As a part of our
Government and Performance Results Act, NIH has developed a long-term,
high-risk goal of identifying at least one clinical intervention that
will delay the progression, delay the onset, or prevent Alzheimer's
disease.
RISK FACTORS
Many Americans wonder whether they or their loved ones are at risk
of developing AD. Sadly, as they age, many of them will be. The risk of
AD increases dramatically with age, with nearly half of all individuals
over age 85 being diagnosed.\3\ Many older Americans struggle with mild
cognitive impairment (MCI), a condition that is frequently a precursor
to AD; in one recent population-based study of cognition in the
elderly, 22 percent of participants over 75, and 29 percent of those
over 85, were diagnosed with MCI.\4\ Determining who is at high risk of
developing AD and who is not--and why--will enable us to identify
potential targets for preventive intervention, as well as those
individuals who might benefit most from such interventions.
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\3\ Data from the Alzheimer's Association. See also Evans, DA;
Funkenstein, HH; Albert, MS; et al. ``Prevalence of Alzheimer's Disease
in a Community Population of Older Persons: Higher than Previously
Reported.'' JAMA 1989; 262(18): 2552-2556.
\4\ Lopez O, Jagust WJ, DeKosky ST, Becker JT, et al. ``Prevalence
and Classification of Mild Cognitive Impairment in the Cardiovascular
Health Study Cognition Study.'' Arch Neuro 60: 1385-1389, 2003.
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Through laboratory, clinical and population-based research, we have
identified a number of risk factors for AD, including both genetic and
lifestyle factors. We already know of three major genes for early-onset
disease and have identified a major risk factor gene, ApoE4, for the
more common late-onset disease. Recent findings are enabling us to
close in on several others, thought to be on chromosomes 9, 10, and 12.
However, neuroscientists have become increasingly interested in a
specific set of genes that may influence not whether, but when, a
person might develop symptoms of neurodegenerative disease. Delaying
the onset of AD symptoms by even five years could greatly reduce the
numbers of people who will have the disease, as well as providing
additional cognitively-healthy time to those who will eventually be
diagnosed.
Recently, NIH-supported investigators found a gene on chromosome 10
that they believe influences the age of onset of both Alzheimer's
disease and Parkinson's disease. Using a novel method to match the
genes of people affected with these diseases with the age at which
study participants started developing symptoms, the scientists found
that one gene, GSTO1, was significantly associated with late onset of
both Alzheimer's and Parkinson's. This important work gives us new
clues to the role of genetics in the timing of late-life forms of these
devastating neurodegenerative diseases.
Last year this Committee heard about the NIA's AD Genetics
Initiative, a program to accelerate the pace of AD genetics research by
creating a large repository of DNA and cell lines from families with
multiple AD cases. The goal of this initiative is to develop strategies
for identifying the additional late-onset AD (LOAD) risk factor genes,
associated environmental factors, and the interactions of genes and the
environment. The NIA's AD Genetics Initiative will intensify sample
collection and encourage data sharing by providing access to a national
repository to qualified investigators.
This year, we have launched several well-integrated components of
the Genetics Initiative. Mechanisms to efficiently identify and share
large numbers of samples for AD genetic analysis have been developed
through the recently-enlarged National Cell Repository for AD (NCRAD),
and eighteen of the NIA's Alzheimer's Disease Centers (ADCs) have
received supplemental funding to recruit new family members for
participation. Uniform standards for sample collection have also been
developed.
In order to publicize the initiative, the NIA Office of
Communications and Public Liaison, together with its Alzheimer's
Disease Education and Referral Center, Columbia University, and NCRAD,
partnered with the Alzheimer's Association to conduct focus groups and
develop materials to publicize the initiative and help recruiting
efforts. These publicity materials, including a workbook, CD ROM, fact
sheet, and brochure were distributed at a recent meeting of all
Alzheimer's centers and have been sent to ADCs and Alzheimer's
Association chapters to further recruitment efforts.
As of Late January, over 200 families, of the approximately 1,000
needed, have been evaluated and are now enrolled in the study, and over
800 blood samples have been logged at NCRAD. Working groups have been
established which are helping to determine the most useful phenotypic
data to be included in the data bank along with the biological samples.
A major goal is the long-term follow-up of individuals participating in
the study.
Type 2 diabetes, which, according to the American Diabetes
Association, affects approximately 17 million Americans, is another
potential risk factor for cognitive decline and AD. In a recent study,
researchers found that compared to older non-diabetic women, older
women with type 2 diabetes were about 30 percent more likely to score
poorly on tests of cognitive function, and that the risk increased with
the duration of their condition. However, the diabetic women in the
study who took glucose-lowering pills had a risk similar to non-
diabetic women. Recognizing the potential link between type 2 diabetes
and cognitive decline, NIA researchers are currently participating in
an offshoot of the National Heart, Lung, and Blood Institute's Action
to Control Cardiovascular Risk in Diabetics (ACCORD) study. ACCORD
evaluates whether more intensive glucose, blood pressure and lipid
management can reduce cardiovascular disease in people with diabetes;
the aim of this sub-study, ACCORD-MIND, is to test whether the rate of
cognitive decline and structural brain change in people with diabetes
treated with standard care guidelines is different than in people with
diabetes treated with intensive care guidelines. Recruitment for the
ACCORD study began in January 2003, and we anticipate that 2,800 people
will participate in ACCORD-MIND.
IMAGING
Powerful imaging techniques, including positron emission tomography
(PET) and magnetic resonance imaging (MRI), are opening a window into
the brain, allowing us to visualize not only anatomical structures but
also functional processes and activities at the molecular level. The
refinement of these techniques continues to have a profound effect on
all areas of AD research.
For example, improvements in brain imaging, coupled with the
development of more sensitive cognitive tests, are enabling us to
diagnose AD in the research setting with greater precision than ever
before, despite the fact that there remains no scientifically validated
method to visualize AD's characteristic amyloid plaques and
neurofibrillary tangles in a living human. However, even this may be
changing. Researchers have recently developed the first radiotracers,
including a molecule called Pittsburgh Compound-B, that facilitate
visualization of amyloid deposition in living AD patients using PET
scans. Although further research is needed, these molecules may
eventually offer us a powerful and accurate diagnostic tool for the
disease.
Visualization of brain structures and activities may also enable us
to identify people at risk of developing the disease even decades
before the onset of symptoms. In a recent study, investigators used
positron emission tomography (PET) to examine the brains of
asymptomatic young adults (ages 20-39) who were carriers of the APOE-e4
gene, a common susceptibility gene for late-onset AD. Middle-aged
carriers of this gene are known to have abnormally low rates of
metabolism in the same brain regions as patients with AD; in this
study, the investigators found the same brain abnormalities in the
younger carriers of the gene. The precise link between the APOE-e4
gene, the altered metabolism, and AD remains unknown, and more research
is needed on this provocative finding, but it may offer important clues
to AD's etiology and perhaps even a target for future prevention
efforts.
Advances in imaging also have the potential to speed our basic
understanding of the disease--for example, to determine which
pathological features of AD (plaque and tangle development, cell death,
loss of connections between neurons) best correlate with cognitive
loss. Improved imaging techniques may further enable us to visualize
the effects of therapeutic interventions more rapidly and accurately,
with the potential for making AD clinical intervention trials smaller,
faster and more affordable.
Last year, we told this Committee about our plans for a
Neuroimaging Initiative, a longitudinal, prospective, natural history
study of normal aging, mild cognitive impairment, and early AD to
evaluate neuroimaging techniques such as MRI and PET, as well as other
biological markers. This year, I am pleased to tell you that work on
the Initiative is underway. We have issued a Request for Applications
and have received submitted applications. In addition, we have secured
the participation of several key industry participants. Awards will be
made this summer, with work on the project to begin shortly thereafter.
The study objectives are to:
--Identify the best markers for early diagnosis of AD
--Identify markers for following disease progression and monitoring
treatment response
--Develop surrogate endpoints for clinical trials
--Decrease time and expense of drug development
--Establish methods for the collection, processing, and distribution
of neuroimaging data in conjunction with other biological,
clinical, and neuropsychological data
The initiative is planned as a partnership among the NIA/NIH,
academic investigators, the pharmaceutical and imaging equipment
industries, the Food and Drug Administration, the Centers for Medicare
and Medicaid Services, and the NIH Foundation, with participation from
the Alzheimer's Association and the Institute for the Study of Aging.
The clinical, imaging, and biological data and samples will be made
available, with appropriate safeguards to ensure participant privacy,
to all scientific investigators in the academic and industrial research
communities.
PREVENTION AND TREATMENT
As imaging and laboratory studies tell us more about AD's
pathology, we are identifying a number of novel molecular
characteristics that may prove to be targets for treating the disease
or preventing it altogether. For example, enhancing the brain's self-
protective capacity by inducing production of naturally-occurring
proteins that destroy beta amyloid shows promise in mice that have been
genetically altered to produce amyloid plaques. In a recent study,
boosting production of two proteins, insulin-degrading enzyme and
neprilysin, in neurons of these mice reduced brain amyloid levels,
slowed or even prevented amyloid plaque formation, and prevented their
premature death.
In this endeavor, animal models--particularly transgenic mice, but
also worms, dogs, and even non-human primates--are invaluable research
resources for studying age-related and disease-related changes in the
brain and for testing promising interventions. For example,
investigators recently studied the effects of an enriched diet on age-
related cognitive decline in dogs, a model that mimics the behavioral
and brain pathological declines of older humans more closely than
rodent models. Young and old dogs were given a series of baseline
cognitive tests. Half of each age group then remained on a standard
diet, while the other half of each age group was placed on a diet
enriched with antioxidants and mitochondrial co-factors, which are
thought to improve nerve cell energy and efficiency and decrease
production of molecules that contribute to oxidative damage in the
brain. Animals remained on their respective diets for six months and
then were assessed again for cognitive performance on a variety of
tasks. When tested, old dogs on the control diet learned more slowly
than the young dogs and made significantly more errors; however, when
compared to the old animals on the control diet, old animals on the
enriched diet showed significantly better learning, although not to the
level of the younger animals. The success of this simple, cost-
effective intervention has significant implications for dietary
interventions that might lessen or even prevent some of the cognitive
decline seen with age and with disease; a pilot trial of similar
antioxidants in older Down syndrome patients who have developed AD is
currently under way.
In fact, NIA is currently supporting 25 AD clinical trials,
including large-scale prevention trials, which are testing agents such
as hormones, anti-inflammatory drugs, statins, homocysteine-lowering
vitamins, and anti-oxidants for their effects on slowing progress of
the disease, delaying AD's onset, or preventing the disease altogether.
Other intervention trials are assessing the effects of various
compounds on the behavioral symptoms (agitation, aggression, and sleep
disorders) of people with AD.
CAREGIVING
Most of the over 4 million Americans with AD today are cared for
outside the institutional setting by an adult child or in-law, a
spouse, another relative, or a friend. Caregivers frequently experience
significant emotional stress, physical strain, and financial burdens,
yet they often do not receive adequate support for their remarkable
efforts. Several recent studies have explored the problems faced by
caregivers of AD patients, and have sought to design interventions to
reduce their burdens. Although family caregiving has been extensively
studied, there has been less research on the impact of end-of-patient-
life on caregivers who are family members of persons with dementia or
to the caregivers' responses to the death of the patient. As part of
the NIA's Resources for Enhancing Alzheimer's Caregiver Health (REACH)
study, a multisite randomized clinical intervention of 1,222 caregiver
and recipient dyads, investigators assessed the type and intensity of
care provided by 217 family caregivers to persons with dementia during
the year before the patient's death, as well as the caregivers'
responses to the death. Additionally, this group was compared to the
180 caregivers who institutionalized their family member. The
researchers found that the in-home caregivers reported tremendous
levels of stress in the year leading up to the care recipient's death,
and that levels of caregiver depression ``spiked'' immediately
following the care recipient death. However, the caregivers in this
study demonstrated tremendous resilience: Within fifteen weeks of the
recipient's death, depression returned to pre-death levels, and within
one year, depression was significantly lower than prior to the care
recipients' death. Importantly, caregiver depression for those placing
their loved ones in an institution was slightly higher both pre- and
post-death than for those caring for the patient at home. These
findings suggest that interventions for caregiver support are
particularly critical in the periods immediately prior to and
immediately after the patient's death.
The NIA's REACH Project, a large, multi-site intervention study of
family caregivers of AD patients, was designed to characterize and test
promising interventions for enhancing family caregiving. Nine different
social and behavioral interventions were tested, and investigators
found that the combined effect of certain interventions alleviated
caregiver burden, and that certain specific interventions, such as
structured family therapy, reduced depression. The second phase of the
study, REACH II, combines elements of the diverse interventions tested
in REACH into a single multi-component psychosocial intervention and is
ongoing.
CONCLUSION
It is difficult to predict the pace of science or to know with
certainty what the future will bring. However, the progress we have
already made will help us speed the pace of discovery, unravel the
mysteries of AD's pathology, and develop safe, effective preventions
and treatments, to the benefit of older Americans.
Thank you for giving me this opportunity to share with you our
progress on Alzheimer's disease. I would be happy to answer any
questions you may have.
Senator DeWine. Doctor, I think what we are going to do is
to ask you to wait. We have several other Senators who, I know,
want to ask questions. And if we could excuse you just for a
moment we are going to put our second panel on and then we will
have your questions. Thank you very much.
Let me introduce our second panel at this point. Sheldon
Goldberg joined the Alzheimer's Association as its present
chief executive officer on December 1, 2002. Previously Mr.
Goldberg was the president and CEO of the Jewish Home and
Hospital in New York. He holds a B.S. in Educational Psychology
from the University of Wisconsin.
Denis Kroucik was an electronics repairman at a steel plant
in Lorraine, Ohio, until he was diagnosed with Alzheimer's
disease in 2002 at the age of 56. He is currently taking one of
the five available Alzheimer's drugs and is participating in an
Alzheimer's study at the Memory and Aging Center at the
University Hospitals of Cleveland. He and his wife Barbara have
six children and five grandchildren and they reside in O'Leary,
Ohio.
Johnny Orr remains the winningest coach in Iowa State
University history, with 218 wins in his 14-season career as
Iowa State University's men's basketball coach. Prior to his
career in Iowa he was the men's basketball coach at the
University of Michigan. Mr. Orr was a two-time All-American at
Beloit College in Wisconsin and played for the NBA, St. Louis
Bombers, and Waterloo Hawks. He is accompanied by his wife,
Romie, who was diagnosed with Alzheimer's disease in October
2002. Mrs. Orr was a physical education teacher prior to her
retirement in 1980. They have been married for 55 years and
have four daughters and six grandchildren. They reside in West
Des Moines, Iowa.
Phyllis Campbell is the president of the Urban League of
Lancaster County, Pennsylvania. She received her Bachelor's
Degree from Morgan State University and her Master's Degree
from the University of Pennsylvania.
David Snowden is a professor in the Department of Neurology
in the College of Medicine in the Sanders-Brown Center on Aging
at the University of Kentucky. He is a director of the Nun
Study, a longitudinal study which looked at the health and
aging of 678 members of the School Sisters of Notre Dame. Dr.
Snowden earned his Ph.D. from the University of Minnesota. He
is accompanied by Sister Kunkel. Sister was educated by the
School Sisters of Notre Dame from elementary school through
college. She received her Bachelor's Degree from the College of
Notre Dame of Maryland, her Master's Degree from Boston
College. She joined the School Sisters in September of 1932. In
1990 she entered the Nun Study. Dr. Snowden devotes an entire
chapter of his book, ``Aging With Grace,'' to Sister and her
life's story. In that chapter she describes herself as having
two good traits, ``I am alert and I am vertical.''
Shelley Fabares is a National Board Member of the
Alzheimer's Association. She starred as a television newscaster
in television's hit comedy series, ``Coach.'' She is also well-
known for her starring roles in ``One Day at a Time'' and ``The
Donna Reed Show.'' Today she dedicates much of her time to the
National Alzheimer's Association. She became involved in the
organization after caring for her mother throughout her 8-year
battle with the disease. She has testified before this
subcommittee in 1990, 1992 and 1993, and we certainly welcome
her back as well. We welcome all of our witnesses.
STATEMENT OF JOHNNY ORR, HUSBAND OF ALZHEIMER'S
PATIENT, WEST DES MOINES, IA
ACCOMPANIED BY ROMIE ORR, ALZHEIMER'S PATIENT
Senator DeWine. Let me start, from my left and your right,
we will start with Mr. Orr. Pass the microphone down and make
sure it is on. You have to push it down.
Mr. Orr. Can you hear me?
Senator DeWine. Very well, very well.
Mr. Orr. Good morning, Senator DeWine and members of the
subcommittee. Romie and I are honored to be in Washington and
are especially glad to see our friend, Senator Harkin. We
haven't seen him yet but I'm sure he's going to be here.
Senator DeWine. He is coming.
Mr. Orr. Romie and I are here today to do whatever we can
to help the fight against Alzheimer's. Like almost everyone
else in this hearing room, we have been touched directly by
Alzheimer's disease. We initially became Alzheimer's advocates
after a very good friend of ours lost his wife. She had
Alzheimer's for 30 years. In the Fall of 2002, I was honored to
be selected as a celebrity chair of the Alzheimer's Association
Greater Iowa Chapter Memory Walk. And about a month after the
Memory Walk, Romie was diagnosed with Alzheimer's. She was 73.
This diagnosis was surprising since Romie was in great shape
and didn't appear to have any health problems. She exercises
regularly and had maintained an active lifestyle since retiring
from her job as a physical education teacher in 1980. There was
no history of Alzheimer's in her family. Although two of our
daughters noticed that Romie occasionally had difficulty
recalling names or events, we both assumed that that memory
lapse was a part of the normal aging process. We mentioned the
memory problems to Romie's physician at her annual physical in
October 2002. A memory test indicated signs of dementia, and we
were referred to an Alzheimer's specialist, Dr. Bender. After
additional tests Dr. Bender concluded that Romie was in the
early stages of Alzheimer's disease. Dr. Bender immediately
started Romie on one of the Alzheimer's drugs currently
available, vitamins E and C and Ginkgo Biloba. Dr. Bender also
encouraged Romie to keep exercising, watch her diet, in
addition to doing other activities to stimulate her brain.
It has been about 18 months since her diagnosis and Romie
is doing quite well. Her Alzheimer's seems to be progressing
slowly and although she no longer drives she still cooks, buns
once in awhile, does laundry and maintains the finances for one
of our three homes. She plays golf, although less often than
she has in the past, and she has no trouble keeping up with our
six grandchildren. She reads a lot, continues to do our holiday
cards, participates in our family gold tournament each Summer,
we go out to dinner regularly with friends and travel between
our homes in Iowa and Florida. She still loves basketball as
much as I do and we're looking forward to attending the NCAA
championship next week in San Antonio. We haven't missed a
tournament in 48 years.
We've learned a lot about Alzheimer's disease since Romie
was diagnosed and we have many reasons to be hopeful.
Significant advances in medical research have resulted in new
and promising treatments. The Alzheimer's drug that Romie takes
is one of five prescriptions available in pharmacies today.
Improved diagnostic tools are helping doctors diagnose
Alzheimer's earlier and with greater accuracy, allowing
individuals like Romie to maintain their quality of life as
long as possible. Scientists are engaged in additional research
to develop strategies for slowing this progression. The goal of
a world without Alzheimer's disease is within reach. In order
to realize a future without Alzheimer's, we must ensure that
the Federal Government maintains its commitment to fund
promising research.
Romie and I thank this committee, and especially you,
Senator Harkin, for your outstanding leadership in the fight to
increase funding for research at the National Institutes of
Health. We recognize that your challenge this year is
especially difficult and pledge to do whatever we can to help
you continue the momentum that has brought us to this historic
point. For our children and grandchildren, and for the families
of people sitting in this room, we cannot afford to back down
now. Alzheimer's is a tough opponent but we can beat it. We
have recruited a dream team of the best scientists and we have
a game plan that will lead us to victory. In order to execute
this plan we need an additional $40 million in funding this
year for clinical trials to identify treatments that can slow
or halt the onset and progression of Alzheimer's.
On behalf of our entire family, Senator DeWine, we thank
you for giving us the opportunity to be here today. And Romie
would now like to say a few words to conclude our testimony.
Senator DeWine. Good. Thank you very much. Mrs. Orr.
SUMMARY STATEMENT OF ROMIE ORR
Mrs. Orr. Good morning.
Senator DeWine. Good morning.
Mrs. Orr. I'm here today because I'm the patient, I'm the
one that has it. My diagnosis, I was lucky. You know, you've
got to get a diagnosis first. And that's not easy because
there's no finite way to say this one has it, this one doesn't.
Charles Coughlin and Robert Bender, both of Des Moines,
together diagnosed me with my Alzheimer's disease. Our two
youngest daughters went with their dad and I to see these
doctors and they were right there when we got the message. But
my family is represented today even though neither of the
doctors could be here. You've met my husband John, our daughter
Jennifer Davis of Lemont, Illinois, daughter Leslie Boylen and
her daughter, Rachel, Laurens, Iowa, daughter Becky Montgomery
and her son Jamie of Anthon, Iowa.
PREPARED STATEMENT
When my Alzheimer's diagnosis was made I didn't feel my
life had fallen apart. I decided, as Johnny told you, not to
drive but I can swim, I can golf and because of my strong
medicine I do walk with the craziest gait you ever saw. It's a
very wide stride so I can keep my balance and not fall over. I
don't want any other Alzheimer's patient to stop living or to
be afraid or depressed or needing to change their life's goals.
I may or may not be a typical patient but I am lucky. With good
doctors, good medicine and a desire to help others with this
disease. I'm here to ask Congress to help their constituents
legislation that will help find that help.
Do you have any questions?
Senator DeWine. Mrs. Orr, thank you very much.
Mrs. Orr. Thank you very much for having me.
[The statement follows:]
Prepared Statement of Johnny Orr
Good morning Senator Harkin, Senator DeWine and members of the
Subcommittee. Romie and I are honored to be in Washington and are
especially glad to see our good friend, Senator Harkin, once again.
Romie and I are here today to do whatever we can to help in the
fight against Alzheimer's. Like almost everyone else in this hearing
room, we have been touched directly by Alzheimer's disease. We
initially became Alzheimer advocates after a very good friend of mine
lost his wife to the disease. In the fall of 2002, I was honored to be
selected as the celebrity chair of the Alzheimer's Association Greater
Iowa Chapter Memory Walk. About a month after the Memory Walk, Romie
was diagnosed with Alzheimer's disease. She was 73 years old.
The diagnosis was surprising since Romie was in great shape and
didn't appear to be having any health problems. She exercised regularly
and had maintained an active lifestyle since retiring from her job as a
physical education teacher in 1980. There was no history of Alzheimer's
disease in her family. Although two of our daughters noticed that Romie
occasionally had difficulty recalling names or events, we both assumed
that the memory lapses were part of the normal aging process. We
mentioned the memory problems to Romie's general physician at her
annual physical in October 2002. A memory test indicated signs of
dementia and we were referred to an Alzheimer's specialist named Dr.
Bender. After additional tests, Dr. Bender concluded that Romie was in
the early stages of Alzheimer's disease.
Dr. Bender immediately started Romie on one of the Alzheimer drugs
currently available, vitamins E and C and ginko biloba. Dr. Bender also
encouraged Romie to keep exercising and watch her diet, in addition to
doing activities to stimulate her brain.
It has been about 18 months since her diagnosis and Romie is doing
quite well. Her Alzheimer's seems to be progressing slowly. Although
she no longer drives, she still cooks, does laundry and maintains the
finances for one of our three homes. She plays golf, although less
often than she has in the past, and has no trouble keeping up with our
six grandchildren. She reads a lot, continues to do our holiday cards
and participates in our family golf tournament each summer. We go out
to dinner regularly with friends and travel between our homes in Iowa
and Florida. Romie may not be able to recall what we had for lunch but
she easily remembers basketball games from my days at Michigan and Iowa
State. She still loves basketball almost as much as I do and we're
looking forward to attending the NCAA championship in a few weeks. We
haven't missed an NCAA tournament in 48 years.
We've learned a lot about Alzheimer's disease since Romie was
diagnosed and we have many reasons to be hopeful. Significant advances
in medical research have resulted in new and promising treatments. The
Alzheimer drug that Romie takes is one of five prescriptions available
in pharmacies today. Improved diagnostic tools are helping doctors
diagnose Alzheimer's earlier and with greater accuracy, allowing
individuals like Romie to maintain their quality of life for as long as
possible. Scientists are engaged in additional research to develop
strategies for slowing the progression of the disease process. The goal
of a world without Alzheimer's disease is within reach.
In order to realize a future without Alzheimer's disease, we must
ensure that the federal government maintains its commitment to fund
promising research. Romie and I thank this committee and especially you
Senator Harkin for your outstanding leadership in the fight to increase
funding for research at the National Institutes of Health. We recognize
that your challenge this year is especially difficult and pledge to do
whatever we can to help you continue the momentum that has brought us
to this historic point. For our children and grandchildren and for the
families of the people sitting in this room, we cannot afford to back
down now.
I faced a lot of tough opponents in 44 years of coaching and I'm
proud to say that I never lost a game without a fight. Alzheimer's is a
tough opponent but we can beat it. We have recruited a dream team of
the best scientists and we have a gameplan that will lead us to
victory. In order to execute this gameplan, we need an additional $40
million in funding this year for clinical trials to identify treatments
that can slow or halt the onset and progression of Alzheimer's disease.
On behalf of our entire family, we thank you for giving us the
opportunity to be here today. Romie would now like to say a few words
to conclude our testimony.
Senator DeWine. We will go through the whole panel and then
we will have some questions. We appreciate you and Mr. Orr
being here very much.
Mrs. Orr. Thank you.
Senator DeWine. Mr. Kroucik. Thank you for joining us.
STATEMENT OF DENNIS KROUCIK, ALZHEIMER'S PATIENT,
ELRYIA, OH
Mr. Kroucik. Thank you for having me. Good morning, Senator
DeWine. My name is Denis Kroucik. I am honored to be here
representing the great State of Ohio and the Cleveland area
chapter of Alzheimer's.
Two years ago, at age 56, I was diagnosed with Alzheimer's
disease. The 3 years prior to my diagnosis were frustrating and
scary for me. I had always enjoyed gardening and was good at
it. I suddenly found it was taking me a whole day to complete
my work when normally it would only take me a few hours. I was
also having trouble at work. At the time I was an electrician
at a steel plant in Lorraine. I would get lost walking around
the plant, couldn't find my way out; I missed routine items on
my safety checklist and couldn't remember my children's names
anymore when co-workers would ask me how they were doing. There
were times I drove home from work at night after working
overtime and I couldn't find my way home. I had to follow other
traffic, hoping I would find my way home. I thought my problems
were caused by lack of sleep, job-related stress because there
were rumors that our plant would be closing and I would lose my
job. And I am also a diabetic and for awhile my wife, Barb,
thought that the problem with fatigue and memory problems were
due to low blood sugar. Barb kept on encouraging me to see a
doctor but I kept on putting it off out of embarrassment. I
figured that it was normal to have memory lapses at my age,
even though it was early 50s.
The turning point came one day at work. I was going through
a routine checklist and forgot to lock out a 13,800 volt bus
supply. I nearly electrocuted myself and a fellow employee.
Barb put me in the car the next day and took me to the doctor
immediately. A week later, after a battery of psychological
tests and an MRI, a neurologist gave me the terrible news,
``You have Alzheimer's disease.'' The changes in my life were
very swift and immediate. I lost my job, had to give up my car
keys. I felt humiliated, useless and I didn't even want to get
up in the morning. I felt like a little kid, wondering if Barb
was going to have to take care of me like my mother once did. I
was angry, depressed, scared and I was losing my independence.
It was a terrible tragedy.
My doctor put me on a newer Alzheimer's drug as well as B-
12, Vitamin E, Ibuprofen. The Alzheimer's drug made such a
difference in my life. I felt human again. Barb and I contacted
the Cleveland area chapter of Alzheimer's Association. The
people at this chapter were so nice and understanding of what
both of us were going through. They helped us learn a lot about
the disease and how it could be treated. I realized then that I
could have a life after Alzheimer's.
Today I work out at the local YMCA twice a week, a friend
drops me off, picks me up. Barb watches me as well; she quit
her job as a furniture salesperson last year so she could spend
more time together with us. Sometimes I get very caught up in
what I'm doing and at times I lose track of time. Barb reminds
me to stop, take a break, have something to eat. I need
especially to be careful because of my diabetes. I am very
active at the Cleveland chapter of Alzheimer's; 2 weeks ago I
spoke at an Alzheimer's legislation in Columbus for the
Alzheimer's Consul Memory Day.
PREPARED STATEMENT
I came to Washington today to testify in this hearing for
many reasons. The most important reasons are my wife, my six
children, and my five grandchildren. I just hope and pray that
I am the only person in my family to experience what it's like
to live with Alzheimer's disease. I am encouraged by the
progress that has been achieved in the fight against this
terrible disease. New research is coming out every day. My
doctors think that we will soon be able to slow the progression
of the disease and the process and postpone the onset of this
risk if the funding for the research keeps pace with the
scientific momentum. I am grateful for the Federal dollars that
have been spent on Alzheimer's research so far and I encourage
this committee to continue to increase the funding for the
research. It won't be easy given the current budget situation.
However, it is something we have to do. We can't afford to
wait. I am participating in an Alzheimer's study in the
University of Memory and Aging at the University Hospitals in
Cleveland. What will happen if the funding of this study is
cut? How many more scientific opportunities will be lost if
Congress decides that we can't afford to increase the funding
for Alzheimer's research? How many more lives will be lost in
this disease?
I want to thank Senator DeWine for inviting me to speak
today. It is an honor to be here and I am happy to answer any
questions you might have.
[The statement follows:]
Prepared Statement of Dennis Kroucik
Good morning Senator DeWine and Senator Harkin. My name is Dennis
Kroucik. I am honored to be here today representing the great state of
Ohio and the Cleveland Area chapter of the Alzheimer's Association.
Two years ago, at age 56, I was diagnosed with Alzheimer's disease.
The three years prior to my diagnosis were frustrating and scary. I had
always enjoyed gardening and was good at it. I suddenly found that it
was taking me a whole day to complete a gardening chore that used to
take only a few hours. I was also having trouble at work. At the time I
was an electrician at a steel plant in Lorain. I would get lost walking
around the plant. I'd miss routine items on my safety checklist and
couldn't remember my children's names when coworkers asked how they
were doing. There were times that I drove home from work at night by
following traffic because I couldn't remember how to get from the plant
to our house. I thought that my problems were caused by lack of sleep
or job-related stress. There were rumors that the plant would be
closing and we'd all lose our jobs. I am also diabetic and for awhile,
my wife Barb and I thought that the fatigue and memory problems were
due to low blood sugar. Barb kept encouraging me to see a doctor but I
put it off. I figured that it was normal to have memory lapses at my
age.
The turning point came one day at work. I was going through a
routine safety checklist and forgot to lock-out a 13,800-volt machine.
I nearly electrocuted myself. Barb put me in the car the next day and
took me to the doctor. A week later, after a battery of psychological
tests and an MRI, a neurologist gave me the terrible news. I had
Alzheimer's disease.
The changes in my life were swift and immediate. I lost my job and
had to give up my car keys. I felt humiliated and useless. I didn't
want to get up in the morning. I felt like a little kid and wondered if
Barb was going to have to take care of me like my mother once did. I
was angry and depressed and scared that I would lose my independence.
It was a terrible tragedy.
My doctor put me on one of the newer Alzheimer drugs, as well as a
B-12 complex, vitamin E and Ibuprofen. The Alzheimer drug made such a
huge difference. I felt human again. Barb and I contacted the Cleveland
Area chapter of the Alzheimer's Association. The people at the chapter
were so nice and understood what we were both going through. They
helped us learn a lot about the disease and how it could be treated. I
realized that I could have a life after Alzheimer's disease.
Today I workout at the local YMCA twice a week. A friend drops me
off and picks me up. Barb watches out for me as well. She quit her job
as a furniture salesperson last year so that we could spend more time
together. Sometimes I get very caught up in what I am doing and lose
track of time. Barb reminds me to stop and take a break or have
something to eat. I need to be especially careful about eating because
of my diabetes. I am very active with the Cleveland Area chapter of the
Alzheimer's Association. Two weeks ago I spoke before more than 100
Ohio legislators at the Alzheimer's Ohio Council Memory Day in
Columbus.
I came to Washington to testify at this hearing for many reasons.
The most important reasons are my wife, my six children and my five
grandchildren. I hope and pray that I am the only person in my family
who will experience what it is like to live with Alzheimer's disease. I
am encouraged by the progress that has been achieved in the fight
against this terrible disease. New research is coming out everyday. My
doctors think that we will soon be able to slow the progression of the
disease process and postpone onset in those at risk if the funding for
research keeps pace with the scientific momentum. I am grateful for the
federal dollars that have been spent on Alzheimer research so far and
encourage this committee to continue to increase the funding for
research. It won't be easy given the current budget situation. However,
it is something we have to do. We cannot afford to wait. I am
participating in an Alzheimer research study at the University Memory
and Aging Center through the University Hospitals of Cleveland. What
will happen if funding for the study is cut? How many other scientific
opportunities will be lost if Congress decides that we cannot afford to
increase funding for Alzheimer research this year? How many more lives
will be lost to Alzheimer's disease?
I want to thank you Senator DeWine for inviting me to speak today.
It is an honor to be here and I am happy to answer any questions you
may have.
Senator DeWine. Thank you very much.
Ms. Fabares.
STATEMENT OF SHELLEY FABARES, NATIONAL BOARD MEMBER,
ALZHEIMER'S ASSOCIATION, STUDIO CITY, CA
Ms. Fabares. Thank you, Senator DeWine and Senator Harkin,
when you get here, nice to see you, and members of the
subcommittee. Thank you for inviting me to testify today on so
important a subject.
Like so many people in this hearing room I have been
touched directly by Alzheimer's disease. My mother Elsa Rose
Fabares, died of this hideous illness in September 1992 after
suffering for 8 long years from the fear, confusion, dread,
increasing incoherence, and ultimately infantile state that it
so often produces. But I'm here today, not only as a family
member; in a way I'm also here as this panel's historian. I
first testified as you said, before Congress about Alzheimer's
disease in 1990 and the last time was actually in 1995, nearly
a decade ago. In the interim I've been struggling with my own
health issues, a hip replacement and liver transplant, and the
time and attention they require. I am happy to report that I am
now feeling great and I am thrilled to be able to come to
Washington again to speak on behalf of the millions of
individuals and families who are dealing with this disease day
in and day out.
Looking back over the past 10 years I am in awe at what has
been accomplished and I am keenly aware that this progress has
been made possible by the support you and the Alzheimer's
Association have given to solving the puzzle of Alzheimer's. To
highlight just a few of the remarkable advances achieved,
though some have already been mentioned, the concepts of cure
and prevention, inconceivable 10 years ago are now real
possibilities. Four treatments have been approved by the FDA
and 20 trials are underway with widely used drugs like
Ibuprofen and Vitamin E that might reduce the risk of
Alzheimer's. We can now diagnose, with a high degree of
accuracy and at much earlier stages of the disease when
available treatments are likely to be the most effective.
That's why people with Alzheimer's, like Frank Carlino, who
testified several years ago, and Mrs. Orr, today are able to
come before you and speak for themselves. Knowledge of the
biology of this disease has opened doors to the possibility of
a vaccine that might fight the toxic proteins that cause
Alzheimer's. Scientists are closing in on the search for
markers that will identify its development long before symptoms
appear, a key to speeding drug trials and targeting new
medications to those who really need them. And research on
therapies and care giving strategies, as well as on the effects
of lifestyle in maintaining cognitive function all promise to
extend independence and keep brains healthy and functioning
longer.
When all these accomplishments are added up it is clear
that your investment in research is paying off hugely.
Scientists who are by nature cautious and skeptical are now
positively exuberant about the promise of prevention and
treatments that will stop or substantially delay this disease.
While they won't be pinned down on a date, most are quite
optimistic that it can and will be done and probably sooner
than they imagined. There is now enough hope and solid
scientific backing for the Alzheimer's Association to launch
its ``Maintain Your Brain'' campaign. This campaign draws on
scientific evidence linking cardiovascular disease and
Alzheimer's and suggests some relatively simple things people
can do to keep their brains, as well as their bodies, healthy.
This too is evidence of the value of our investments in
research over the past 10 years.
I've spent a lot of time traveling around the country
talking to individuals and families who are dealing with
Alzheimer's disease. A few have been able to come to Washington
to tell their own stories, like Christine Frey, from Peoria,
Illinois, who talked about her seven relatives who've already
died from the disease and how it hangs like a death sentence
over her own life. Like Maureen Reagan, or 10-year-old Walter
Dawson of Falls City, Oregon, whose father's Alzheimer's
disease jeopardized his future. Or Catherine Brewer of
Northport, New York, or Beverly Hines of Vassalboro, Maine, who
both suffered terrible stress-related illnesses directly linked
to their care giving responsibilities.
Now, because of better diagnostic tools, more people with
the disease are speaking up and speaking out for themselves. No
one is better able to convey the urgency or our research
efforts than someone living with Alzheimer's and talking to us
in her own voice. And the voices, sadly, are increasing in
numbers, leaving few families untouched. The Coalition of Hope
that we are going to be announcing today is further evidence of
the growing chorus of Americans who are no longer willing to
sit on the sidelines and allow this disease to consume our
families and our Nation with its voracious and destructive
appetite. The Coalition members understand all too well that if
we don't continue our commitment to Alzheimer's research we
face a bleak future indeed.
Mr. Chairman, when I was last here science was just
building the caissons on either side of this vast Alzheimer's
river. These caissons that would form the foundation for a
scientific bridge that someday will allow us to surmount the
human destruction caused by this river. But the bridge is not
complete and the river's rush continues to consume millions of
lives. We are well within striking distance and we can finish
the bridge but only if we maintain our investment in research.
Would the public sit by quietly if we were to stop construction
on any of Nation's major bridges when they were 50 to 80
percent finished? Of course not. Nor will they nor can they sit
by if we shift our attention away from completing the job of
Alzheimer's disease when we are so close. The millions of
victims past, present and future demand that the job be
finished and the sooner the better. The consequence of success
are huge, the consequences of failure too horrific to
comprehend.
PREPARED STATEMENT
For Mrs. Orr and her children, for Christine Frey and
Walter Dawson and Frank Carlino, for our parents, our children
and ourselves, we urge you to please stay the course so we can
someday have a world without Alzheimer's.
Thank you very much.
[The statement follows:]
Prepared Statement of Shelley Fabares
Mr. DeWine, Senator Harkin, members of the Subcommittee. Thank you
for inviting me to testify today on so important a subject.
Like so many people in this hearing room, I have been touched
directly by Alzheimer's disease. My mother, Elsa Rose Fabares, died of
this hideous illness in September of 1992 after suffering for eight
long years from the fear, confusion, dread, increasing incoherence and
ultimately infantile state that it so often produces.
But, I'm here today not only as a family member. In a way I'm also
here as the panel's historian. I first testified before Congress about
Alzheimer's disease in 1990, and the last time was in 1995, nearly a
decade ago.
In the interim, I've been struggling with my own health issues--a
hip replacement and liver transplant--and the time and attention they
require. I'm happy to report that I'm now feeling great and am
delighted to be able to come to Washington again to speak on behalf of
the millions of individuals and families who are dealing with this
disease day in and day out.
Looking back over the past 10 years, I am in awe at what has been
accomplished. And I'm keenly aware that this progress has been made
possible by the support you and the Alzheimer's Association have given
to solving the puzzle of Alzheimer's. To highlight just a few of the
remarkable advances achieved:
--The concepts of cure and prevention, inconceivable 10 years ago,
are now real possibilities.
--Four treatments have been approved by the FDA and twenty trials are
underway with widely used drugs, like ibuprofen and Vitamin E,
that might reduce the risk of Alzheimer's.
--We can now diagnose with a high degree of accuracy, and at much
earlier stages of the disease--when available treatments are
likely to be most effective. That's why people with
Alzheimer's, like Frank Carlino who testified several years
ago, and Mrs. Orr today are able to come before you and speak
for themselves.
--Knowledge of the biology of this disease has opened doors to the
possibility of a vaccine that might fight the toxic proteins
that cause Alzheimer's.
--Scientists are closing in on the search for markers that will
identify its development long before symptoms appear--a key to
speeding drug trials and targeting new medications to those who
really need them.
--And, research on therapies and caregiving strategies, as well as on
the effects of lifestyle in maintaining cognitive function, all
promise to extend independence and keep brains healthy and
functioning longer.
When all these accomplishments are added up, it is clear that your
investment in research is paying off hugely. Scientists, who are by
nature cautious and skeptical, are now positively exuberant about the
promise of prevention and treatments that will stop or substantially
delay this disease. While they won't be pinned down on a date, most are
quite optimistic that it can and will be done, and probably sooner than
we ever imagined.
There is now enough hope and solid scientific backing for the
Alzheimer's Association to launch its ``Maintain Your Brain'' campaign.
This campaign draws on scientific evidence linking cardiovascular
disease and Alzheimer's, and suggests some relatively simple things
people can do to keep their brains as well as their bodies healthy.
This, too, is evidence of the value of our investments in research over
the past 10 years.
I've spent a lot of time traveling around the country talking to
individuals and families who are dealing with Alzheimer's disease. A
few have been able to come to Washington to tell their own stories,
like Christine Frey from Peoria, Illinois, who talked about her seven
relatives who've already died from the disease and how it hangs like a
death sentence over her own life. Like Maureen Reagan. Or 10 year-old
Walter Dawson of Falls City, Oregon, who father's Alzheimer's disease
jeopardized his future. Or Catherine Brewer of Northport, New York, or
Beverly Hines of Vassalboro, Maine, who suffered terrible stress-
related illnesses directly linked to their caregiving responsibilities.
And, now because of better diagnostic tools, more people with the
disease are speaking up and speaking out for themselves. No one is
better able to convey the urgency of our research efforts than someone
living with Alzheimer's and talking to us in her own voice.
And the voices, sadly, are increasing in numbers, leaving few
families untouched. The Coalition of Hope that we are announcing today
is further evidence of the growing chorus of Americans who are no
longer willing to sit on the sidelines and allow this disease to
consume our families and our nation with its voracious and destructive
appetite. The coalition members understand all too well that if we
don't continue our commitment to Alzheimer's research we face a bleak
future indeed.
Mr. Chairman, when I was last here, science was just building the
caissons on either side of this vast Alzheimer's river, these caissons
that would form the foundation for a scientific bridge that someday
will allow us to surmount the human destruction caused by this river.
But, the bridge is not complete and the river's rush continues to
consume millions of lives. We are well within striking distance and we
can finish the bridge, but only if we maintain our investment in
research.
Would the public would sit by quietly if we were to stop
construction on any of our nation's major bridges when they were 50
percent or 80 percent finished? Of course not. Nor will they--nor can
they--sit by if we shift our attention away from completing the job on
Alzheimer's disease when we are so close. The millions of victims--
past, present and future--demand that the job be finished, and the
sooner the better. The consequences of success are huge; the
consequences of failure too horrific to comprehend.
For Mrs. Orr and her children, for Christine Frye and Walter Dawson
and Frank Carlino . . . for our parents, our children and ourselves, we
urge you to please stay the course so we can someday have a world
without Alzheimer's disease.
Senator DeWine. Thank you very much. Mr. Goldberg.
STATEMENT OF SHELDON GOLDBERG, PRESIDENT AND CEO,
ALZHEIMER'S ASSOCIATION, CHICAGO, IL
Mr. Goldberg. Thank you Senator DeWine, Senator Harkin. I
appreciate the opportunity to again appear before this
committee. And I again remind you I am privileged to be part of
the Alzheimer's Association and serve as its president.
As you may well know, the goal of the Alzheimer's
Association is very singular in purpose. It is to provide to
care and support but also and perhaps more importantly to find
a cure for this disease to create the world without Alzheimer's
disease. And I am privileged to come and tell you that we can
now start communicating to our public that there is progress
being made and the possibility even exists that we can see the
time when we can find a way of stopping this disease. And that
is a direct result of research.
Senators, it is because of you, it is you have led the
charge, it is you who have had the vision, it is you who have
provided the funds to provide the research, and we appreciate
it greatly. And I think you're seeing some of the results of
that research. There are successes and there is a very
optimistic future to go ahead. And so I am privileged to be
able to convey to the American people, on behalf of the
Alzheimer's Association that tremendous hope exists that we can
defeat this disease in the time to come.
I am privileged to also introduce to you today and
introduce again to our public a new coalition. And this
coalition has come together and it represents at this time 60
million Americans, over 150 organizations and growing on a
daily basis. And it includes the usual organizations to some
degree. Certainly the Older Women's League is a member,
certainly Family Care givers Alliance, the National Center on
Black Aging, AARP, and the National Association of Retired
Federal Employees. But I have to tell you that this coalition
is just beginning and its taken on a whole new crew of
suspects. And let me share some of the names.
The Philadelphia Grange has joined us. And the Iowa Egg and
Milk Producers have signed on, as this is their cause. The
Kentucky Farm Bureau has joined us. The Idaho Fraternal Order
of Police. The Tennessee Firemen's Association, the Mississippi
School Administrators, the Indian Tribes of Alaska, the Urban
League, the NAACP, LULAC, the American Baptist Church,
Presbyterian Congregations, Catholic Congregations, Episcopal
Congregations, Jewish Congregations and the list goes on and
on. We've been joined by union locals from Teamsters and
Electrical Workers, to State legislators and to representatives
of county government. To the Sons of Italy and to the Polish
American Congress. And this is just to mention a very few of
the organizations that have joined us and I promise you that
many more will be joining us in this movement to find a way of
curing this disease.
You know, it's interesting, why would they join this cause?
Why would these new suspects come to the cause of Alzheimer's
where traditionally it has been an aging cause? And that is
very simple. This disease touches so many peoples' lives. It
touches families, it touches communities and it destroys
individual lives. And people are beginning to realize very
clearly it does not recognize race, it does not recognize
income, it does not recognize where you live, it doesn't pay
attention to your occupation. It is evident that presidents
will get this disease and have gotten this disease, and people
from all positions in life are suffering from this disease. And
these organizations are joining us in our fight to find a way
of curing this disease. The movement wishes to accomplish one
thing, and that is to ensure that Alzheimer's is not inevitable
and that Alzheimer's is not hopeless and that the research
continues. They simply know that their families and their
communities and their basic economic security is being
undermined and that is the reason these organizations have come
together. They clearly understand that it is bankrupting our
Federal Government, and I mean by that, its impact on Medicare
and its impact on Medicaid. They see very clearly that it is
draining millions, billions of dollars from American industry
and it is destroying the retirement security that people feel
and the serenity that they feel in their lives.
You noted that there are 4.5 million Americans today
afflicted with this and countless family members, and these
numbers are going to grow geometrically as the baby boomers
begin to--as we see the iceberg of the baby boomers coming down
because we are only seeing the tip of the iceberg at this point
in time. The baby boomers will have a tremendous impact as we
move into this century and this disease will cause tremendous
havoc, both on these individuals' family, on the health care
and the American business which we all want to flourish and
succeed. And that is the reason the Coalition has come
together.
We are very, very concerned that the funding which you have
started and the leadership from this Committee and the leader
from this body continue. We are asking this body to continue
with at least $40 million to continue the research that has
been started, to continue the progress of finding a solution,
to finding a cure to this horrible disease. I promise you that
this Coalition will only grow stronger, it will become more and
more of a movement as more and more people understand the
dimensions and the impact this disease is having on our
society, on our government, on our industry and all the
destruction it causes on the families.
PREPARED STATEMENT
So on behalf of the Alzheimer's Association, and I say on
behalf of this Coalition of Hope, which represents countless
American people, we thank you for your leadership and we ask
for your support and continue the funding and increasing the
research.
Thank you very much, Senators.
[The statement follows:]
Prepared Statement of Sheldon Goldberg
Senator DeWine, Senator Harkin. Thank you for inviting me back to
talk to you about Alzheimer's disease. I am even more excited to be
here today than I was last year at this time.
The Alzheimer's Association's goal of delaying the disabling
symptoms of Alzheimer's disease, and eventually preventing the disease
now appears possible. For the first time, creating ``A World Without
Alzheimer's'' is within reach. And it's because of you--your vision in
claiming the Alzheimer research agenda and your steady, sustained
commitment to moving it forward.
Because of your leadership, we can go to the American people now
with a new message of hope. We can--we will--have a future where
Alzheimer's disease is only a memory.
This morning, I speak not just for the Alzheimer's Association but
also on behalf of a new Coalition of Hope, which we are announcing
today.
This is a coalition of over 150 organizations, representing more
than 50 million Americans, who have joined the fight against
Alzheimer's disease. You can count on us to support of your efforts to
increase funding for Alzheimer research and services.
The Coalition includes groups you might expect to see--the Older
Women's League, the Family Caregiving Alliance, the National Center and
Caucus on Black Aging, AARP, the National Association of Retired
Federal Employees. We are grateful for their support.
But this movement extends far beyond the aging community. Take a
close look. It includes, for example:
--The Pennsylvania Grange, Iowa Eggs and Milk Producers, and the
Kentucky Farm Bureau,
--The Idaho Fraternal Order of Police and the Tennessee Firemen's
Association,
--The Mississippi Association of School Administrators,
--The Indian Tribes of Alaska, the Urban League, the NAACP and LULAC,
--Southern Baptist, Catholic, Episcopal, Jewish, Assembly of God,
Presbyterian, and Assembly of God Congregations,
--Locals of the International Brotherhood of Electrical Workers and
Teamsters,
--State legislators and county governments, and
--The Sons of Italy and the Polish American Congress.
Why, one might ask, have all these ``unlikely suspects'' made
Alzheimer's their cause. They have joined us in the fight against
Alzheimer's because it's a disease that touches so many families and
communities. It doesn't recognize race or income, or whether you live
in a big city or small town. But for the first time ever there's hope
to significantly delay the onset of the disease and lessen its impact.
These organizations have joined us to ensure that Alzheimer's disease
need not be inevitable or hopeless.
But left unchecked, Alzheimer's will undermine our families,
communities, and basic economic security.
It will overwhelm our health care system, bankrupt Medicare and
Medicaid, drain billions of dollars from American business, and destroy
retirement security for tens of millions of families.
--Today, 4.5 million Americans and their families are already facing
Alzheimer's, with all of its emotional and financial
devastation.
--Millions of workers are leaving their jobs or cutting back work to
provide Alzheimer care. That lost productivity is the major
reason why Alzheimer's is costing American businesses an
estimated $61 billion.
--Medicare is spending 3 times more on beneficiaries with Alzheimer's
disease. Six years from now, Alzheimer's will cost the program
$50 billion.
--State Medicaid programs are spending $18 billion to help people
with dementia pay for their nursing homes. That will bill be 80
percent greater by 2010.
But this is all just the tip of the iceberg. The babyboomers are
still below the surface. When Alzheimer's starts to hit them, the
numbers will begin to skyrocket. By the middle of the century, 11 to 16
million could have the disease. We will not be able to withstand the
explosion of costs--to families, to taxpayers, to the health care
system, to American business.
The Coalition of Hope is organized to make sure that does not
happen. If the current pace and momentum is maintained we may be able
to delay the onset and progression of the Alzheimer's as well as
prevent the disease, saving not only billions of dollars to our health
care system but also saving millions of lives. The baby boomers may
indeed be the first generation not having to face Alzheimer's.
But for those who may still get it, we will slow its progression
enough that most will never reach the advanced stages of the disease.
That means we will no longer have nursing homes filled with people with
dementia.
This is not the time to tell the scientists to slow down. But that
is exactly what will happen unless we continue to expand the public
investment in Alzheimer research.
I am not a scientist, but I have spent a lot of time talking with
scientists. Let me give you just a few examples of the opportunities we
will miss if we stick with current and proposed funding levels:
--Thanks to your investment, the best scientists in the world are
chomping at the Alzheimer bit--and that means NIA is receiving
record numbers of applications. But at current budgets, they
will be able to fund only about 15 percent of those proposals--
for less than the 20-25 percent of past years. And they can
only do that much by cutting $1 of every $5 out of the
successful grants. Think how many scientific opportunities we
are missing.
--Even existing, highly productive program projects are at risk. The
Healthy Aging and Dementia project at Washington University in
St. Louis is just one example. This is the team that created
the assessment instrument that is now the clinical standard.
They discovered with others the concept of mild cognitive
impairment. Now they have turned to the next critical question
in Alzheimer prevention--how to identify ``normal'' adults who
are at high risk, so we can treat them in time. The St. Louis
team started recruiting people in their 40s and 50s whose
parent had Alzheimer's. These volunteers have been through a
lot already--blood draws, lumbar punctures, and MRIs. But they
are going to have to put that study on hold, because NIA is
cutting their approved budget by 30 percent.
--What about the large scale clinical trials that have been so much
the focus of this Committee's concern? After all, research
doesn't mean a lot in the real world until we are successful in
getting science from the bench to the bedside.
--Scientists at the University of California in San Diego are
poised to start the next big trial of combinations of anti-
oxidants. This offers one of the most exciting
possibilities for a safe and relatively inexpensive way to
protect against Alzheimer's. But NIA does not have the
money to get it started.
--Even trials that are well underway--like the ginko biloba trial
Dr. DeKosky testified to this Committee about--will have to
be slowed down. There may be no money to analyze the data
that has already been collected on the hundreds of
volunteers who have participated in this trial.
This is a travesty. We cannot let it happen.
We know you face many competing priorities, with very little
discretionary money in the budget.
We understand that, after doubling the NIH budget, there are those
who are ready to say, ``we've done enough.''
But if we slow down now, we will be throwing away much of the
investment the American taxpayers have already made in Alzheimer
research.
We must continue, and build on, the progress of the last twenty
years.
We are asking you to increase funding for Alzheimer research by $40
million for fiscal year 2005 to maintain the ongoing national
collaborative research to improve neuroimaging technologies for early
detection and large-scale clinical trials to test the effectiveness of
vitamins and other large-scale clinical trials for treatments that
would slow or delay the progression of Alzheimer's.
Research on Alzheimer's is on the brink of major breakthroughs that
will provide the effective means to delay and, ultimately, to prevent
the devastation of dementia.
This effort will not be possible without your support, the
Coalition of Hope, and the nationwide network of investigators working
closely with the NIA's 29 Alzheimer's Disease Centers around the United
States.
That is a modest request, given the urgency of the Alzheimer crisis
and the enormity of the scientific opportunities. But it would be
enough to sustain the momentum in tough budget times.
On behalf of the Alzheimer's Association and the entire Coalition
of Hope, thank you.
Senator DeWine. Thank you very much. Dr. Snowden.
STATEMENT OF DR. DAVID SNOWDEN, PROFESSOR IN THE
DEPARTMENT OF NEUROLOGY AND THE SANDERS-
BROWN CENTER ON AGING AT THE UNIVERSITY OF
KENTUCKY, LEXINGTON, KY
ACCOMPANIED BY SISTER GENEVIEVE KUNKEL, NUN STUDY PARTICIPANT
Dr. Snowden. Good morning. I am David Snowden, I am a
Professor of Neurology from the Sanders-Brown Center on Aging
at the University of Kentucky Medical Center. I'm also the
Director of the Nun Study, a longitudinal study on aging and
Alzheimer's disease. I am here not just to describe some of the
important findings of our study but also to emphasize the
importance of this type of research and to urge you to find
some way to keep this and other critical research going
forward.
To understand how disease is caused and prevented, we
usually follow a population of people over time and see who
develops the disease and who doesn't. In 1990 funding from the
National Institute on Aging allowed us to start a long-term
study of older members of the School Sisters of Notre Dame
Congregation. Three factors made this population of nuns a rich
source of research data and biologic material. First, members
of this community have a shared common environmental lifestyle
from early adulthood, which holds many confounding factors
constant. Second, each convent has an archive of information on
each Sister, from the time she entered the congregation as a
young woman until her death. The archives provide a unique
window into the early and middle lives of the Sisters decades
before any of them developed Alzheimer's disease. The third
critical element is the courage and altruism of this inspired
group of women, all of whom agreed to donate their brains at
death for our studies.
The 678 nuns agreed to give us complete access to their
personal and medical records and participate in annual
examinations of their mental and physical function. We have
followed them meticulously since 1990 and to date almost 500
brains have been donated, making it one of the world's largest
neuropathologic studies. Participants in our study range in age
from 75 to 107 years of age. Sister Genevieve Kunkel, from our
Baltimore convent who is sitting with me today, is a stellar
example from our study. She has avoided Alzheimer's and aged in
a truly healthy and beautiful manner. Sister Genevieve
describes healthy aging as being ``alert and vertical.'' And in
her comments at the end of my presentation you'll witness the
human potential available to all of us in a world without
Alzheimer's disease.
The Nun Study represents a long-term investment. Since 1990
we have received $12 million of funding from the National
Institute on Aging. Has the investment been worth it? You be
the judge. We were the first study to show how a preventable
disease like stroke can trigger the symptoms of dementia in
persons with an Alzheimer's brain. We were one of the first
studies to show that a deficiency in folic acid, a vitamin,
accelerates the brain-damaging effects of Alzheimer's disease.
We were the first study to show that Alzheimer's pathology and
symptoms are predicted by low linguistic ability in
autobiographies completed 60 years before. This suggests that
Alzheimer's, like cancer and heart disease, is a lifelong
disease process.
This is only the beginning. We still have a great deal more
to do and are accelerating our progress by sharing our unique
research materials with other scientists. For example, if we
secure funding scientists at several collaborating universities
will use genetic material to create a complete genetic library
for each nun. A non-human genome project, if you will, that
will be linked to our treasury of information from the Sisters'
medical and personal histories, annual medical exams and
autopsy findings. Since we began the Nun Study, we have seen an
explosion in medical and scientific technology which has opened
up enormous opportunities for discover. The price tag for these
sophisticated studies has skyrocketed. It's offset, however, by
the knowledge gained that leads to new prevention strategies
that can reduce human suffering and health care costs.
I urge Congress to find some way to significantly increase
research funding because a world without Alzheimer's is
literally within our grasp.
Now I would like to ask Sister Genevieve Kunkel, one of our
participants in the Nun Study, to add some brief comments.
Sister Genevieve Kunkel. Thank you. Let me begin by saying
I pray daily for wisdom and prudence and this morning I prayed
extra hard for these gifts. It has been privilege and pleasure
to be an active participant for 14 years in Dr. Snowden's
research. And there have been some personal perks, like an
appearance with him and Katie Couric and a full chapter in his
book, ``Aging With Grace.'' Not displeasing at all for one in
her late 80s.
It is rewarding to have frequent, friendly and informative
reports from Dr. Snowden and his dedicated staff, assuring us
Sisters that the donation of our brain is contributing
significantly to this promising study of the dread disease of
Alzheimer's. As a School Sister of Notre Dame for more than 72
years, it is good for mind and spirit and body to know that I
can still, even as a fully-retired Sister, continue to be a
vital part of this ongoing project. My philosophy as a woman, a
religious and a teacher, has always been to be grateful for the
past, enthusiastic about the present and confident about the
future. Dr. Snowden's cause is a good one. I'm grateful for it
and enthusiastic about it.
PREPARED STATEMENT
I was asked a second question. What is it like to watch
those with whom you live afflicted with Alzheimer's? To phrase
it bluntly it isn't easy. As a Sister, my faith that this is
part of the Pascal mystery of Lent, reaching up or leading up
to Easter and eternal life, eases the pain somewhat. May 1, I
will celebrate the 70th anniversary of my professional vows, a
commitment I made in 1934 with 55 other young women. It is
saddening to watch my friends, my Sisters stricken with the
diminishments of ailing and failing. And when these are
accompanied by Alzheimer's it seems and is so much more
devastating. How painful to see Sisters much younger than I
enter this darkened world. How often I ask, why them? Why not
me? Living with this reality daily has made me more prayerful
about finding a cure and more zealous to remain actively
involved in the Nun Study of Dr. Snowden.
Thank you very much.
[The statement follows:]
Prepared Statement of Dr. David Snowden
Good morning. I am Dr. David Snowdon and I am a Professor in the
Department of Neurology and the Sanders-Brown Center on Aging at the
University of Kentucky Medical Center. I am the director of the Nun
Study, a longitudinal study of health and aging.
I am delighted to be here with the School Sisters of Notre Dame--
not just to describe some of the important findings of our study, but
also to emphasize how important this type of long-term research
investigation is to solving the enigma of Alzheimer's disease, and to
urge you to find some way to keep this critical work going forward--as
fast as possible.
Prevention depends upon understanding risk factors and how we can
protect against them. To do that, we usually follow a population of
people over a time and see who develops disease and who doesn't. After
conducting a pilot study of Minnesota nuns in the 1980s, the staff of
the National Institute on Aging encouraged us to submit a grant
application to expand the Nun Study to all older School Sisters of
Notre Dame throughout the United States, including those living in
Minnesota, Wisconsin, Illinois, Missouri, Maryland, Connecticut, and
Mississippi. The institute funded our study in 1990, and it has been
ongoing ever since.
Three factors made this religious population a rich source of
research data and biologic material. First, this is a community whose
members have had shared a common environment and lifestyle from early
adulthood--which holds many confounding factors relatively constant.
Second, each convent has an archive of information on each sister, from
the time she entered the congregation as a young woman until her death.
The archives provide a unique window into the early and middle lives of
the sisters, decades before any of them developed Alzheimer's disease.
The third critical element is the courage and altruism of this
inspired group of women, all of whom agreed to donate their brains at
death for our studies. This allowed us to investigate risk and
protective factors by comparing the brain tissue of cognitively-intact
sisters to those who had severe symptoms of Alzheimer's, and every
shade of gray in between these extremes. The 678 nuns in our study
agreed to give us complete access to their historic personal and
medical records, and participate in annual examinations of the mental
and physical function. We have followed them meticulously since 1991
and to date almost 500 brains have been donated by these carefully
studied women--making it one of the world's largest neuropathologic
studies.
Participants in our study range in age from 75 to 107 years old.
Sister Genevieve Kunkel from our Baltimore convent, who is sitting with
me today, is one of our stellar examples from the study. She has
avoided Alzheimer's and aged in a truly healthy and beautiful manner.
Sister Genevieve describes healthy aging as being ``alert and
vertical''--in her comments at the end of my presentation you will
witness the human potential available to all of us in a world without
Alzheimer's.
I would like to underscore that this has been an interdisciplinary
effort at the University of Kentucky--involving social scientists,
anthropologists, molecular biologists, pathologists, and physicians. As
we have progressed to more sophisticated questions, we are increasingly
engaging scientists from other research institutions and other
scientific disciplines. To maximize the federal government's and the
sisters' investment in this study, we are making our rich source of
data and tissue available to researchers across the United States.
The Nun Study represents a long-term investment by the Federal
Government. Since 1990, we have received $12 million from the National
Institute on Aging. Has the investment been worth it? You be the judge.
--We were the first study to show how a preventable disease like
stroke can trigger the symptoms of dementia in a person with an
Alzheimer-brain.
--We were one of the first studies to show that deficiency in the
vitamin Folic Acid appears to accelerate the brain-damaging
effect of Alzheimer's disease.
--We were one of the first studies to show that Alzheimer's, like
cancer and heart disease, is a life-long disease process. While
it has been known for decades that low education is a risk
factor for Alzheimer's, it has not been know why--is it related
to early brain and cognitive development, a higher prevalence
of lifestyle risk factors, or reduced access to health care in
those with low education? Early cognitive development is likely
to be a primary explanation. Linguistic analyses of
autobiographies written by the nuns in early life indicates
that low verbal skills are a potent predictor of Alzheimer's
pathology in the brain and Alzheimer's symptoms 60 years after
the autobiographies were written.
And this is only the beginning. We still have a great deal more to
do.
We continue to pursue other novel approaches to the study of
Alzheimer's disease. For example, over 95 percent of people will
develop the protein deposits, the so-called plaque and tangle lesions
of Alzheimer's, if they live to be old enough. Yet most will somehow
escape showing any significant symptoms of this disease. We and other
scientists are trying to get a better understanding how such people
avoid symptoms despite having the disease present in their brain.
We are also carefully studying the small minority of participants
who never show the development of any significant Alzheimer's lesions--
people who truly inhabiting a pristine world without Alzheimer's. Once
we understand that, we'll be in a much better position to develop
preventive interventions.
If we can attain additional funding in the future, the long-term
investment by the National Institute on Aging will provide even more
added-value:
i. For example, with nearly 500 brains in hand we are now working
with world-renowned experts in the study of blood vessel
diseases. This will allow us to get a better understanding of
how the health and disease status of microscopic, small, and
large blood vessels in the brain are related to Alzheimer's,
other dementias, overall health and function, and longevity. By
sharing brain tissue and data already collected on nearly 500
study participants with scientists at other U.S. research
institutes, our colleagues there will have the ability to
quickly and inexpensively perform new promising investigations
that would otherwise cost literally 10's of millions dollars
and take 10 to 20 years to complete. With only a couple
millions dollars of funding, we can have the answers within a
few years.
ii. Working with scientists at the University of Kentucky, Johns
Hopkins University, and the University of Minnesota, we are now
pursuing a strategy to use the genetic material collected from
these nuns to ultimately create a genetic library for each of
the 678 study participants. That is, the complete genome of
each sister, all 30,000 plus genes, will ultimately be
described and available in a computer database. If this study
is funded, instead of going to the laboratory to study a single
gene, investigators will simply log onto to the Nun Study
Genetic Library to access the entire genetic structure of each
sister, as well as all the risk factor data, medical history,
and findings from the brain autopsy.
Since we began the Nun Study, we have seen an explosion in medical
and scientific technology and methods, which has opened up enormous new
opportunities for discovery. When we began, in 1991, we asked the
sisters to donate some blood for future studies. At the time, we
envisioned looking at nutrients and other chemicals in the blood, and
possibly a gene or two. Never would we have imagined that development
of technologies like gene amplification and micro-array analysis would
allow us to determine the entire genome of individual sisters; or that
we would need sophisticated data storage and data analyses techniques
to handle this mind-boggling amount of genetic information. All of
these add value to what we started, but, they all cost money.
The Nun Study is just one example of how the National Institute on
Aging has capitalized on a long term funding strategy to provide a
unique perspective on aging and Alzheimer's disease. Other
investigators are pursuing unique populations, and there is much that
remains to be done, especially in the study of dementia in specific
racial and ethnic populations--an area of study that at best, we have
only rudimentary understanding.
We cannot put these studies off years and decades into the future.
We need to conduct them now. There is still time to find answers and
get interventions in place before the disease progresses further in the
baby boomers, and subsequent generations. With only a minimal increase
in National Institutes of Health funding this year, our research team
and others across the United States will be stalled in our search for
vital information about the prevention and treatment of this
devastating disease. I urge Congress to find a way to make the
commitment to finish the job it started. A world without Alzheimer's is
within our grasp.
Senator DeWine. Sister, thank you very much.
Let me turn at this point to Senator Harkin. Before I do,
let me just, if I could, make a comment, and that is that
Senator Specter and Senator Harkin, as already been noted by
several of our panelists, have certainly been the great leaders
in this Congress and in this country for funding of
Alzheimer's, as they have in other areas of health research.
And it has been my privilege to serve with both of them here in
Congress and just to watch this great leadership. So, Senator
Harkin, your comments?
STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Well Mr. Chairman, thank you very much. I
apologize for being somewhat late. I am also going to apologize
for having to leave early. I have two cities from Iowa who are
waiting for me over in the Russell Building right now, that is,
the Chambers of Commerce and business leaders that I have to go
meet with. You understand that, right Johnny? And so I will
apologize for leaving a little bit early also.
I just want to thank all of you for being here. You will
excuse me if I pick on a couple of people. First, Shelley
Fabares, who said she was first here in 1990, I remember it
well, I was chairman at that time of this subcommittee, and
came back repeatedly every year for the Alzheimer's
Association. You know my thoughts and prayers were with you
during your struggles in the 1990s when you had your own health
problems but your husband continually assured me that you were
a fighter and that you were going to get through it. And it is
great to see you here and looking so well again, Shelley.
Ms. Fabares. Thank you, Senator.
Senator Harkin. It is great to have you back.
Ms. Fabares. Thank you so much.
Senator Harkin. And just again, thanks for never giving up
in your own personal struggle but also in the struggle for
continued increased funding for Alzheimer's. You have just been
a real stalwart for the last, well, 16 years, I guess it is
since I have known you.
To Johnny and Romie Orr, again, thank you for being here.
And for giving witness and testimony to what you have been
through. I do not know if it was said, Mr. Chairman, but Johnny
Orr is the winningest coach in Iowa State University history
basketball. That is my alma mater so I follow that pretty
closely. And you and Romie have been married how long? Fifty-
five years now, did you say? Fifty-five years. Good for you.
And I know how much you have worked on this issue, we have
talked about it in the past and it is just good to see you
here. Romie, I know that you have been doing a lot of good
things. Oh, by the way, I notice that your doctor is Dr.
Bender. He is a great doctor. He treated my brother and got him
through some years of some dementia problems also so I have
great respect for him and for his ability. So you are living
proof that he does pretty good stuff, right? Gives you good
advice.
RESEARCH APPLICATION FUNDING
To the rest of you who are here. Dr. Hodes, thank you for
your leadership at the National Institute on Aging. I would
like to just ask what the funding this year would mean for the
Neuroimaging Initiative that you are doing in terms of how many
applications, how many research applications can actually be
funded compared to what we were doing in the past. If you could
either answer it now or I can just submit that in writing and
you can get it back to me because I want to know what this
small increase in funding that we have this year, what that may
mean. And if you have a succinct answer, if you could just
respond to me on that. What are we looking at in terms of the
reduced number, if there will be one, in funding for peer-
reviewed grant applications that would be involved with the
Neuroimaging Initiative?
Dr. Hodes. Well, if I may, sir, just to answer first
generally for NIA and for the Alzheimer's research supported by
NIA, whereas in prior years we were able to fund approximately
25 percent or one-fourth of meritorious applications our best
estimates at this point of the year is that we're funding
approximately 15 percent. And in order to accomplish that we in
fact have had to make very significant reductions in the amount
of award to even achieve a raised pay line or a higher success
rate for Research Project Grants (RPG).
Senator Harkin. So 15 percent and with reduced awards.
Dr. Hodes. This is correct.
Senator Harkin. And in the past you have been as high as
20?
Dr. Hodes. Approximately 25 percent.
Senator Harkin. 25 percent. I just want to note that for
the record, Mr. Chairman, that even though we are giving a
slight increase what it means is that we will be able to fund
fewer grants, and I did not know about the reduced amount of
the awards also.
Dr. Hodes. I don't want to miss this or any opportunity to
thank Congress for the support in the past or in the period
they're doubling in particular. The success of this investment
is, I think, manifest in the number of investigators who are
now taking advantage of past research findings and
opportunities and submitting meritorious applications. And a
part of the challenge in funding an appropriate percentage is
that the ingenuity, the opportunities, the genius of the
scientific community has not slowed down even if the budget
increase has.
Senator Harkin. Very good. Again, Johnny and Mrs. Orr,
thank you very much for being here. I am really proud of you
and proud to represent you here in the U.S. Senate. These are
two of our best known Iowans, of course, as I said, he coached
Iowa State, and that's the premiere college in America, we know
that. But actually, Romie is really the expert, right?
Mr. Orr. I was at Michigan too, don't forget.
Senator Harkin. I know but that was a long time ago.
Mr. Orr. Senator Harkin, we've been involved in a lot of
things in Iowa together.
Senator Harkin. Yes.
Mr. Orr. And he's always been very supportive and you know,
I can't explain to you, I was worried about the time element,
but until it hits you, or someone close to you, it's hard to
explain it. It's really hard to explain it.
Senator Harkin. Romie, I mean, I know you are under Dr.
Bender's care but what are some of the things you are doing now
to kind of forestall the impact of Alzheimer's?
Mrs. Orr. I'm taking Aricept.
Senator Harkin. Oh yes.
Mrs. Orr. Which is a wonderful medication. I take one pill
a day. And then I take a large range of vitamins, Gingko Biloba
and Vitamin E and Vitamin C. And I take the vitamins twice a
day and I take Zoloft at night.
Senator Harkin. Yes.
Mrs. Orr. And I'm getting along fine. I have a wonderful
time. I'm a rug hooker. I hook rugs.
Senator Harkin. Okay.
Mr. Orr. Imagine me marrying a hooker? Been living with her
for 55 years.
Senator Harkin. She hooked you good.
Mrs. Orr. My current project is a big tapestry of the
harvester, up by Marshalltown.
Senator Harkin. Yes, sure.
Mrs. Orr. And I'm going to put, I just told my daughters
today that I'm going to put the Alzheimer's signature right
underneath my signature on this work of art; I call it a work
of art. I was given the ability to copy it, for one copy.
Senator Harkin. Well Romie, you are a former physical
education instructor.
Mrs. Orr. Right.
Senator Harkin. So obviously you are in great physical
shape. You said something about your doing mental things, too.
Hooking rugs, obviously, but what else?
Mrs. Orr. Well, that helps so, it really does because
there's a bit of color planning and everything going all
through that.
Senator Harkin. I see.
Mrs. Orr. The other thing I do is play solitaire. I play
three games of two different solitaire every single day, no
matter what.
Senator Harkin. Oh, that is good.
Mrs. Orr. It keeps me sharp. It takes a lot of time so I
don't have to stay in the kitchen all day long.
Mr. Orr. You have to be careful at our house, anymore, what
you grab though, sometimes. She put the Cascade in the
refrigerator the other day and that was a little difficult
mixing that up, you know? But we've done great.
Senator Harkin. That is good.
Mr. Orr. And we've approached this thing as optimistically
as you can possibly do it. And so have my daughters and
hopefully we're going to whip this thing. And it's a terrible
thing.
Senator Harkin. Well, I would expect nothing less than the
utmost optimism from Johnny Orr, I can tell you that, and Romie
also, both of you. And thank you all again, very much. Shelley
again, it is great to see you back and it is great to see you
back in full health again. It is wonderful. And please give
Mike my best.
Ms. Fabares. I will. Thank you.
Senator Harkin. Thank you all very much. Thank you, Mr.
Chairman.
Senator DeWine. Thank you very much. Dr. Snowden, tell us a
little bit more about your study. What activities early in
life, let us put this maybe in a practical, easy to understand
for anybody who might be watching this or who might read about
it, what activities would you recommend or things would you
recommend for people early in their life? And then, what would
you recommend for someone later in their life? Someone who is
60, 70 years old, 80 years old. However later in life is. I
mean, what did you learn, just tell us what you learned that
would be helpful to people? Some of this is heredity,
obviously, but some of it maybe can be influenced.
Dr. Snowden. Well, Alzheimer's is obviously a thinking
disease and it does make some sense that your development of
thinking abilities in early life may play a role in buffering
you against this thinking disease decades later, as well as
maintaining your thinking ability throughout your middle and
late ages. It's been known for probably 15, 20 years that
education is strongly related to the risk of dementia; the
lower the education, the higher the risk of Alzheimer's
disease. And that's true whether you're in China, France,
Africa, or in the United States. What it is about education in
early life has been a little bit of a mystery. With the Sisters
we have the benefit of having autobiographies that Sister
Genevieve and others wrote when they were in their early 20s
and teens. And so we have looked at the linguistic ability, or
basically the number of ideas that they can pack into sentences
60 years before they ever developed Alzheimer's disease, and we
can see basically that those who had really good language
ability could pack a lot of sentences--a lot of ideas into
sentences. And 60 years later when we looked at their brain
they had dramatically less Alzheimer's disease in their brain
and they have a dramatically lower risk of Alzheimer's. So
obviously language is extremely important, it's probably the
key human skill that we have that we do our best work and our
worst work through organizing groups through language. And
language is probably the thing that really, when it starts to
decline in Alzheimer's then you have all sorts of social
problems and the patient being able to communicate with the
family and the family communicating with the patient. So,
simply promoting education, Head Start, probably during the
first 5 to 6 years of life is really critical in developing
language ability. And this is obviously a good thing anyway
because we're all big advocates of education.
During middle again, certainly----
Senator DeWine. Which gives us one more reason to do what
we should be doing anyway.
Dr. Snowden. Absolutely, right, absolutely. So education is
really, it's a critical, it's a, you know, major foundation for
so many things and may have implications decades and decades
later on your risk of Alzheimer's and health care costs. So
certainly education is a key factor and particularly early-life
education is important.
During middle life it's important to maintain your
cognitive abilities and that can be something as simple as
buckling your seatbelt up because we know that head injury is
also a risk factor for Alzheimer's disease. It's certainly
something that's preventable and something that we should do
for other very good reasons. And certainly trying to prevent
other diseases to have affects on thinking ability like stroke
is something one can do through middle and late age. It's
always been an issue though, you know, does reading and doing
the New York Times puzzles and so forth, crossword puzzles,
will that have an effect on your risk of Alzheimer's. And
that's been difficult because as people develop the disease
obviously their thinking ability and their ability to do
crossword puzzles decline. So it's hard to know which came
first, the low ability in doing crosswords or reading or do the
Alzheimer's symptoms come first. But because of the funding
from the National Institute of Aging there have now been
clinical trials that have been started and results are starting
to come out suggesting that if you experimentally randomly
assign thinking tasks to elderly people that that will help
them maintain their thinking abilities and the suggested
evidence is that this ultimately may lead to a lower risk of
Alzheimer's.
So I'd say the bottom line is that, you know, whether or
not you get any disease, be it an infectious disease like HIV
or a disease like cancer, heart disease or Alzheimer's, there's
a consequence of a long chain of events and starting from
conception with the genes to young age to middle age and late
age, and so what we want to do as individuals and public is we
want to focus in on the weak links in that chain that we can do
something about. Certainly education, certainly prevention
programs for head trauma, stroke prevention programs,
nutritional programs also, I think, will have a potentially
large effect if we can get more funding of nutritionally
studies. Because Alzheimer's is a brain-wasting disease and it
makes sense that the last thing you want to do when your brain
is being wasted by Alzheimer's is nutritionally deprive it. So
eating a lot of fruits and vegetables and for scientists to
figure out what is it about specific components of diet, from
Gingko to teas to vitamins that may help in slowing down the
degeneration of the brain tissue.
Senator DeWine. Did your study, and anybody else can jump
in here, I am not going to just focus on Dr. Snowden's study,
but anyone else who wants to jump in is fine, on the nutrition
side, did your study indicate any, as far as the history of the
nuns, maybe it was a more controlled group there, were you able
to tell any difference in the nutrition there?
Dr. Snowden. Well certainly our big finding in the
nutrition area has been with the vitamin Folic Acid, that we
could see as the higher of the blood level of the Folic Acid in
the Sister that even when she had Alzheimer's disease in her
brain that the higher the Folic Acid the less damage to the
brain with Sisters who had an Alzheimer's brain. So Folic Acid
is extremely important from conception on and obviously is
critical to the development of the spinal cord and the brain
during the fetal development. Certainly for the March of Dimes
that's probably their poster child now is they're really trying
to get pregnant women, or women who may get pregnant, to eat
Folic more, to get more Folic Acid even before they know
they're pregnant. So we know it's important in the development
of the nervous system, the brain and the spinal cord. It
shouldn't be too surprising to suggest that it also may be very
important in the maintenance of the brain, particularly when
it's under attack. But that's just one potential candidate. Dr.
Hodes could tell us much more about the possibilities of new
findings and new studies going on in nutrition. It's something
we all can do.
Senator DeWine. My wife was the nutritionist in the family.
What does that translate for me, for the average person. What
does that mean? What do you eat, what do you not eat? What does
that translate to? What is the diet recommendation?
Dr. Snowden. Well, the easiest way is a multi-vitamin pill.
Senator DeWine. Okay, that is the cheap way, maybe not
cheap, that is the easy way.
Dr. Snowden. Because of a Federal lawsuit many years ago
that Folic Acid was added to enriched wheat products that means
that whether you're eating pretzels on the plane or enriched
breads or breakfast cereals, the Folic Acid--this was designed
to try to get Folic Acid in the food stream so that women,
before they got pregnant or before they knew they were
pregnant, were getting Folic Acid. And that's what's happened
over the last several years is that the Folic Acid levels have
risen dramatically in the United States. And if Folic Acid ends
up being definitely shown to reduce the risk of Alzheimer's
disease the Federal law that got Folic Acid into the food
stream may end up being the really first classic health
maneuver that was designed to reduce Alzheimer's disease
without changing anybody's behavior.
Dr. Hodes. I'd be happy to elaborate on that.
Senator DeWine. Please, jump in, Doctor.
Dr. Hodes. As Dr. Snowden has emphasized we've learned a
lot from clinical and epidemiologic studies, and the Nun Study
is an eminent one among those. But what we've learned are
suggestions of factors which may correlate with risk of
Alzheimer's disease and therefore which may be causally
related. So as he points out, clues come from educational
history or diet, and most importantly these clues then need to
be translated into clinical studies that directly test the
effects, along the lines of nutrition and the specific agents
that have been mentioned already; there are studies in progress
looking at the effects of Folate, B vitamins, antioxidants and
their impact on Alzheimer's. And these are studies that are
capable of providing the most definitive answers.
The other general point that I would make in elaboration is
that in addition to the important factors through the
developmental lifespan of an individual from conception to
birth and on, we've learned things in the past decade or so
about changes which can occur in an adult, even in older
adults, that really ran in the face of what had been dogma not
so long ago so that Dr. Snowden and others in the field well
understand. A decade of so ago it was well presumed that the
brain cells one had as an adult were all one was ever going to
have, there was no capacity to regenerate new brain cells. So
when cells were lost they were lost forever without
replacements. We've learned from animal studies and from humans
that in fact the brain is capable, in critical areas, of
generating new cells and intriguingly that in animal studies in
particular it appears that the pace at which these new cells
are generated can be influenced by activity, by physical
activity and by intellectual or environmental challenge. So
there is hope not only for interventions early in life, which
we would all agree are the most effective for prevention, but
also for interventions throughout the lifespan that are capable
of modifying, preventing and, in principle, even reversing some
of the neuronal loss or loss of function in brain cells that is
the hallmark of Alzheimer's disease.
Mr. Goldberg. Senator.
Senator DeWine. Mr. Goldberg.
Mr. Goldberg. We indicated that we started a Coalition to
do this but part of this is also a concept called ``Maintain
Your Brain'' and we'll be doing lots of advertising. And there
are only indications, but strong indications, such things as
high cholesterol levels, such things as diabetes, watching your
sugar, such things as maintaining a good proper blood pressure,
all have indications, as well as diet, all have indications
that they may help to promote a healthier lifestyle, a better
heart but also diminish the risks of Alzheimer's as well. And
so that is a message we are going to try to convey to the
American people as well, that these things can help, perhaps if
not give you a better heart but we think have strong
indications to help maintain the brain as well.
Senator DeWine. That is basically one more reason to do all
the right things, then.
Mr. Goldberg. Just what our mothers told us.
Senator DeWine. So, I guess one summary would be to also
stay intellectually active. I assume that would have some
positive impacts. Dr. Snowden, do we have any data on that? I
mean, that is intuitively what you would think but is there any
kind of data on that?
Dr. Snowden. Yeah, well there are some clinical trials that
have come out that suggest that experimentally getting older
Americans to do mentally challenging activities seems to reduce
the decline in mental function. But my understanding is that
these studies really didn't have the capacity to enroll
thousands of people in order to directly test whether that
actually ended up reducing the risk of developing Alzheimer's.
These studies ultimately will lead to that but it will take
more and more years. I mean, basically the National Heart and
Lung and Blood Institute, you know, in the 1960s and 1970s put
literally billions of dollars into large-scale population
studies in order to study things that we take for granted now,
like blood pressure and cholesterol and diet and smoking. We
need that kind of, you know, I know it's probably fantasy land
but that's the kind of commitment we need, that we've committed
billions into studying the heart, I think we need to commit
billions into studying large human population studies,
particularly clinical trials so we can figure out what to tell
people. Because ultimately it's going to end up reducing
dramatically health care costs and human suffering. The
ultimate in all this is prevention. It's like people drowning
in a river and somebody's physician's down there trying to pull
people out of the river who are drowning and somebody comes up
to him and says the bridge is broken upstream, and the
physician says, I'm too busy here to fix the bridge. Well, we
need to fix the bridge. That's where the future is, is in
preventing these diseases. And in general a lot of things that
appear to be good for the heart, for overall health are good
for the brain. So a lot of the potential interventions really
could reduce Alzheimer's but also reduce stroke, heart disease
and potentially cancers as well. So there's a lot riding on
this and you pay now or you pay huge amounts later in human
suffering and health care costs.
Senator DeWine. I want to get back to the question of the
money. This subcommittee, frankly, when you testify in essence
you are preaching to the choir. As you know, this subcommittee
is very, very supportive, the chairman has been very, very
supportive, as you know, Senator Harkin has, the rest of us
have been. But I would like for you, any of you, to try to
maybe put this in perspective as far as when we look at the
next few years, and you have touched on this a little bit, but
try to give us some idea so as we talk to our colleagues and as
we talk to our constituents and we talk to the taxpayers, what
we can tell them, what, in these tight budget times, what
additional money, what we can expect it possibly can do. You do
not have a crystal ball but what is the best case here? Give us
the ammunition.
Mr. Goldberg. Could I make two arguments? If you go to a
Governor today in America he will tell you that the thing that
is driving the State budgets, which are in trouble, is
Medicaid. And the biggest reason people are in nursing homes in
this country is Alzheimer's disease. Sixty-five percent of the
people in nursing homes today carry a diagnosis of Alzheimer's
disease. And what's facing you dramatically is the Medicare
program. The Medicare program, a person with Alzheimer's
disease, costs three times the amount as the same person at the
same age go broke. And if you start looking at the what the
baby boomers, the numbers that are going to retire in a few
years, they will drive the Federal budget. And I happen to
believe there will be such a crisis in the Federal budget that
I think it will cause the Medicare program to go broke. I think
that is the driver. There was a commercial a few years ago, I
remember this, it says, you pay me now or you pay me later. I
don't think we can afford the price later.
Senator DeWine. Anybody else? Good. Very good. Dr. Hodes,
you want to take this on a little bit?
Dr. Hodes. Yes, thank you.
Senator DeWine. You have already touched on this a little
bit but just kind of give us the big, long-term view on this.
FUNDING IMPACT
Dr. Hodes. Yes, to expand on what I'd said earlier, these
past years through the wisdom and generosity of Congress and
the American public have seen the kind of explosion and
information about Alzheimer's that we've heard about today
translated now into larger number of prevention and treatment
trials than have ever been possible before. And we have now a
research community with true genius that is energized with
ideas for translating basic science and laboratory discovery
into clinical trials and interventions. The momentum of the
science in this field is reflected in the applications that we
have before us for studies that span the spectrum of basic
science through clinical application which we will, with
whatever funds are made available, support to the best wisdom
of peer review and our own priorities. However, it is also
quite clearly true that the numbers of meritorious applications
that cannot be funded under this present year's budget is
something far in excess of what we've seen before. What does
this mean beyond numbers? What does it translate into? It means
that we will have fewer opportunities to carry out the basic
science to understand the molecular underpinnings of disease
which are the basis for understanding future interventions. It
means more immediately that we will have to make difficult
choices about which promising interventions we attempt. We will
not be able to carry out as many studies as rapidly as
possible, which in the end, predictably, will have the effect
of delaying ultimately what we all feel confident will be the
cure. So the more restrained we are in budget now, even with
our best exercise of judgement, predictably the more time it
will take to make the progress necessary to finally address the
problem and eradicate it.
Senator DeWine. Very good. Well, we just appreciate your
testimony, all of you, very much. It has been very, very
helpful. It has really put a human face on this very, very
tough disease and we appreciate all of you taking your time to
travel here and to testify. And on behalf of all the
subcommittee we really, really appreciate it. We are going to
continue our commitment, I think you know this subcommittee is
behind you and behind these efforts. So we are going to
continue to work with you and look forward to continuing our
efforts together. Thank you very much.
ADDITIONAL SUBMITTED PREPARED STATEMENTS
We have received the prepared statements of Senator Mary L.
Landrieu and Phyllis Campbell, president, Urban League of
Lancaster County, PA. They will be placed in the hearing
record.
[The statements follow:]
Prepared Statement of Senator Mary L. Landrieu
Thank you, Mr. Chairman.
The subject of today's hearing is one that deserves our utmost
attention. It is estimated that today, 4.5 million Americans have
Alzheimer's Disease (AD). As the average life expectancy continues to
increase, and the baby boomer population, as much as some of us may
like to deny it, are beginning to age, the number of people affected
with AD will skyrocket. If the current trend of AD continues, it is
expected that by 2050, between 12 million and 16 million people will
suffer with AD. Something must be done to prevent these estimates from
becoming fact.
Much advancement has been made in the field of AD research.
Scientists have discovered many of the common characteristics of
patients with AD: it is clear that age is a factor; scientists have
noted the large deposits of beta-amyloid that occur during the process
of AD; having large amounts of homocysteine can almost double one's
chances of having AD, as research has shown. These advancements are
great and have allowed scientists to find drugs that can help slow down
the effects of AD, however, there is still no known cure. The fact of
the matter is that today, if you are diagnosed with AD, you will have
AD for the rest of your life, and it is highly probable that AD will
cause your death.
It is clear that more research is needed to find a cure for AD, but
we as the keepers of the purse strings for federal medical funding, we
are not allowing this research to take place. In the fiscal year 2004
appropriations bill, the boost in funding for Alzheimer research at the
National Institutes of Health (NIH) was only 3.7 percent, compared to
the 15 and 16 percent increases that we have given NIH during the five
years prior. Similarly, the funding for the Alzheimer Disease
Demonstration Grant Program was cut by $1.5 million in fiscal year
2004. And it appears that these trends of lowered funding are not
stopping. In the President's fiscal year 2005 Budget Request, the
funding level for Alzheimer research at NIH was increased by only 2.7
percent.
As the federal deficit continues to balloon out of control, we must
be wise in how we spend our money. One practical way to prudently spend
our money is to fund projects and research that will save us money in
the future. Funding Alzheimer research is a prime example of this. If
scientists can discover a cure for AD, we would literally save billions
in the next few years. It is estimated that if the number of people
affected by AD continues to increase as expected, the cost of AD on
Medicare will increase from $31.9 billion in 2000 to $49.3 billion
(over 50 percent) by 2010, while the cost of AD on Medicaid will
increase by 80 percent (from $18.2 billion to $33 billion) over that
same period of time. Moreover, government is not the only entity
getting hit with this heavy bill. Today, seven out of ten people
affected with AD live at home with 75 percent of their care being
family and friends. This causes AD to cost American businesses over $60
billion every year, over half of which is costs relating to caregivers
of AD, loss in productivity, absenteeism, and worker replacement. By
actually increasing funding for research to find a cure for AD, we can
prevent these extreme costs from occurring.
AD affects millions of Americans: one out of every ten Americans
has a family member who is stricken with this fatal disease, and one
out of every three Americans knows someone with it. We are on the brink
of being able to reverse the current rising trends of AD, but in order
to do this we must provide scientists and researchers with the funds
they need. Thank you.
______
Prepared Statement of Phyllis Campbell, President, Urban League of
Lancaster County, Pennsylvania
Good morning, Senators. Thank you for inviting me here today. I am
honored--and a bit overwhelmed--to sit here with people who are
devoting their lives to the fight against Alzheimer's disease. And I
want to pay a special tribute to Coach and Mrs. Orr for their courage
in sharing their very personal story.
Let me make clear at the outset that I am not an expert on
Alzheimer's disease. I have friends and acquaintances who are
struggling with this awful disease, and I see the horrible toll it is
taking on them. I consider myself fortunate that my family does not
have first hand experience with this disease.
So, why I am testifying. I am here as the President of the
Lancaster County Urban League. We are one of more than 150
organizations, representing over 53 million people, that have joined
the Alzheimer's Association in a Coalition of Hope, to bring more
attention and resources to the fight against Alzheimer's disease.
As you know, the African-American community faces many public
health crises--from infant mortality, to AIDS, to heart disease and
diabetes. While our attention was otherwise focused, Alzheimer's
disease has invaded our community and stolen from us some of our
richest resources--our grandparents, our parents, our spouses.
Alzheimer's has become a silent epidemic among African-Americans.
But we can be silent no longer. That is why we, like many other Urban
Leagues around the country, have joined the Coalition of Hope.
There are at least five compelling reasons why African-Americans
must join the fight against Alzheimer's.
First, we are getting older--and age is a key risk factor for
Alzheimer's. By the middle of the century, there will be four times as
many African-Americans aged 65 and over than there are today (11
million compared with 2.8 million in 2000). And there will be six times
as many of us aged 85 and over (over 2 million compared with 300,000
today)--when we will be most at risk for Alzheimer's. If we come down
with Alzheimer's at the same rate everyone else does, more than 5
million African-American babyboomers will get Alzheimer's disease.
Second, there is evidence we may be at greater risk than others.
I'm told that three out of four studies that have looked at Alzheimer's
in our community show rates of dementia ranging from 14 percent to 100
percent higher than in white Americans. We need to figure out why this
is happening, and what we can do about it.
Third, there is growing and alarming evidence that Alzheimer's may
be linked to vascular disease, which is rampant in our community. I've
heard about the study that shows people with high blood pressure are
twice as likely to get Alzheimer's. That frightens me, because 65
percent percent of African-American elders have hypertension (compared
with 51 percent of white elders.) And African-Americans have a 60
percent higher risk of type 2 diabetes--a condition that contributes
directly to vascular disease.
Fourth, dementia among African-Americans is seriously unreported.
We tend to be diagnosed at later stages of Alzheimer's, even though
everything I've heard is that treatment works best when it is started
early in the disease. We must get our community to recognize the early
signs of dementia, to understand that this is not just normal aging,
and to seek evaluation and treatment.
Fifth, we must make sure that potential treatments for Alzheimer's
will work for African-Americans. There is growing evidence that the
genetics of Alzheimer's may be different in African-Americans, and that
our response to drug treatments may vary. NIA must have the resources
it needs to identify all of the genetic risk factors for Alzheimer's
disease, and to speed up the clinical trials of promising drug
therapies. And we must make sure there is enough money in those studies
to involve sufficient numbers of African-Americans in order to draw
valid and specific conclusions for our community.
That is why I am here today, on behalf of the Lancaster County
Urban League and all of the members of the Coalition of Hope--to urge
you to provide sufficient funds for NIA and NIH to complete its work on
Alzheimer's disease. So that Alzheimer's will become nothing more than
a memory, not just for African-Americans but for all of us.
Thank you.
ADDITIONAL COMMITTEE QUESTIONS
Senator DeWine. There will be some additional questions
which will be submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Mary L. Landrieu
Question. Some critics of increasing funding for research have
argued that the increases NIH received for Alzheimer research prior to
last fiscal year flooded NIH, and thus increases of that size are no
longer necessary. Will the decrease in the rate of increase of funding
impede Alzheimer research at NIH? If so, what will you not be able to
do now?
Answer. A decrease in funding at this time would mean the National
Institute on Aging (NIA) could not award grants to Alzheimer's disease
(AD) research projects at levels recommended by the scientific peer
review process. The NIA pay line for AD research will only reach to
around 16 percent in fiscal year 2004, compared to 25 percent in fiscal
year 2003. This means that only 1 out of 6 peer-reviewed studies is
able to be funded. To reach even this level, new awards have had to be
cut by an average of 18 percent, with the result that applicants have
had to remove some of their aims, or in the case of large grants, some
whole projects have been eliminated. The surge in Alzheimer's disease
(AD) research initiatives and grant applications generated by the
generous doubling of NIH budget between fiscal year 1999 and fiscal
year 2003 continues at a volume that far exceeds current or projected
funding. In fiscal year 2004, the NIA received many more grant
applications than anticipated (approximately 40 percent more
applications in fiscal year 2004 than received in fiscal year 2003),
and at the same time, average grant costs have risen.
The budget doubling of past fiscal years has also fast-tracked NIA
AD clinical trials and made possible some exciting and innovative
research collaborations. Continued funding at adequate levels will be
needed to maintain and promote these scientific endeavors. NIA supports
approximately 25 AD clinical trials, including large-scale prevention
trials, which are testing agents such as anti-inflammatory drugs,
statins, homocysteine-lowering vitamins, and anti-oxidants for their
effects on slowing progress of the disease, delaying the onset of AD,
or preventing the disease altogether. The price of conducting these AD
prevention trials has increased and cost from $6 to $8 million per
trial annually to enroll the needed number of subjects (as many as
2,000 for some studies) and to evaluate treatment effects. Finding a
biological way to accurately track AD development and progression is
one of the objectives of the $60 million, 5-year NIA Neuroimaging
Initiative (ADNI). This is a large-scale public-private partnership
among NIA/NIH, academic investigators, the pharmaceutical and imaging
equipment industries through the Foundation for the NIH, the Food and
Drug Administration, and with participation from the Alzheimer's
Association. This initiative is slated to begin in October 2004 with
patient recruitment in April 2005. At current funding levels, only MRI
and PET, but not other imaging modalities, will be evaluated in the
ADNI for utility as surrogate markers in AD. These other modalities
could include, for example, magnetic resonance spectroscopy (MRS) to
measure certain neurochemical compounds, functional MRI (fMRI) to
measure brain function in response to certain stimuli, and diffusion
tensor imaging (DTI) to measure the fiber pathways that connect
different parts of the brain.
Question. A large amount of progress in finding a cure for
Alzheimer's Disease has been made in recent history, and it appears
that we are on the brink of finding a cure. Pretending that money is an
unlimited resource, how much money do you estimate it would take to
find a cure for AD?
Answer. It is difficult to predict the pace or certainty of
scientific discovery or to estimate the funding needed to find a cure.
However, it can be said a significant increase in funding for
Alzheimer's disease research would allow for new and expanded efforts
in basic, translational and clinical research, while capitalizing on
the many new initiatives and findings that were made possible during
the years of the NIH doubling, including the entry of new investigators
into this challenging field of AD research.
Recent advances in Alzheimer's disease research, coupled with new
and improved technologies in areas such as imaging, as well as the
ever-expanding knowledge and tools available in the field of genetics,
are creating new opportunities to make advances in preventing,
treating, slowing the progression and possibly curing Alzheimer's
disease. Researchers continue to make new basic research discoveries
about the death of neurons and loss of their connections, and how to
prevent this; pathways leading to plaque and tangle formation, and how
to remove them, including promising vaccine therapy; protein
aggregation and how to dissolve the aggregates; and underlying causes
of memory loss and how to prevent this. In the area of translational
research, better animal models of AD for testing possible therapies are
being developed and many studies are being conducted on possible ways
of preventing amyloid and tangle accumulation. Pre-clinical drug
research and AD Prevention trials are providing us with some
information which will be crucial to understanding how to prevent or
delay the onset of Alzheimer's.
CONCLUSION OF HEARING
Senator DeWine. Thank you all very much for being here.
That concludes our hearing.
[Whereupon, at 10:30 a.m., Thursday, March 23, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]