| National Institute on Aging, Industry Launch
$60 Million Alzheimer's Disease Neuroimaging Initiative
The National Institute on Aging (NIA) in conjunction with other
Federal agencies, private companies and organizations today launched
a $60 million, 5-year public-private partnership the
Alzheimer’s Disease Neuroimaging Initiative to test
whether serial magnetic resonance imaging (MRI), positron emission
tomography (PET), other biological markers, and clinical and neuropsychological
assessment can be combined to measure the progression of mild cognitive
impairment (MCI) and early Alzheimer's disease (AD).
The study could help researchers and clinicians develop new treatments
and monitor their effectiveness as well as lessen the time and cost
of clinical trials. The project is the most comprehensive effort
to date to find neuroimaging and other biomarkers for the cognitive
changes associated with MCI and AD.
Within the Federal Government, the NIA is joined in the partnership
by another National Institutes of Health (NIH) Institute
the National Institute of Biomedical Imaging and Bioengineering
(NIBIB) and by the Food and Drug Administration, all of which
are part of the U.S. Department of Health and Human Services. The
Foundation for NIH is managing corporate and other private participation,
and has received commitments totaling more than $20 million
in contributions from the following companies and organizations:
Pfizer Inc, Wyeth Research, Eli Lilly and Company, Merck &
Co, Inc., GlaxoSmithKline, AstraZeneca AB, Novartis Pharmaceuticals
Corporation., Eisai Global Clinical Development, Elan Corporation,
plc, the Institute for the Study of Aging (ISOA) and the Alzheimer's
Association. About two-thirds of the funding is expected to come
from the Federal Government while private partners are expected
to make up the other third. Ancillary studies will be funded by
additional NIH grants.
"This is an extraordinary pooling of talent and resources
toward a common goal delaying or preventing Alzheimer's
disease," says Richard J. Hodes, M.D., Director of the NIA.
"The initiative should become a landmark study in the development
of neuroimaging and other biomarkers, helping us to find biological
changes early so that we can identify the people at highest risk
of the disease and test the effectiveness of new therapies more
quickly and efficiently."
The study will take place at approximately 50 sites across the U.S.
and Canada. In April 2005, investigators will begin recruiting about
800 adults, ages 55 to 90, to participate in the research approximately
200 cognitively normal older individuals to be followed for 3 years,
400 people with MCI to be followed for 3 years, and 200 people with
early AD to be followed for 2 years.
The study will compare neuroimaging, biological, and clinical information
from these participants, seeking correlations among the data that
will track the progression of memory loss from its earliest stages.
Neuroimaging research has suggested that PET or MRI may serve as
a more sensitive and consistent measure of disease progression than
the neuropsychological and cognitive assessments now typically used
in research and clinical practice. As MCI and AD progress, for example,
areas of the brain involved with memory, such as the hippocampus
(a part of the brain heavily involved in memory), shrink.
Using the high resolution images produced by MRI, researchers will
evaluate the best ways of measuring this volume loss in the hippocampus
and other brain structures. PET scans assess brain function by measuring
the rate of metabolism of glucose, the brain's fuel. PET scans
of people with AD show that glucose in certain parts of the brain
is metabolized at lower levels than in healthy people, and previous
studies have shown that low glucose metabolism can be seen in some people even before noticeable symptoms of memory loss
occur. The Initiative will seek to identify additional biological
factors from blood, cerebrospinal fluid (CSF), and urine samples.
"The key challenge here is to identify critical markers that
respond to treatments aimed at slowing the progression of mild cognitive
impairment and Alzheimer's disease," says Michael W. Weiner,
M.D., the study's Principal Investigator.*
"For example, today, imaging is used to rule out other causes
of memory problems, still not leaving the researcher or the clinician
with a very clear idea of what is going on. By the end of this study,
we should be able to use imaging and other biomarkers to accurately
monitor disease progression and detect the effects of treatments
which can slow that progression."
Information about the participating research sites and co-investigators
leading various aspects of research may be obtained from the NIA.
While recruitment for the study will not begin until spring 2005,
people interested in participating in the study can contact the
NIA's Alzheimer's Disease Education and Referral (ADEAR)
Center at 1-800-438-4380 for additional information.
The NIA leads the Federal effort in research on AD and age-related
cognitive change. The Institute is currently funding 6 prevention
trials and 19 treatment trials for AD, in addition to the Neuroimaging
Initiative. For more information on participation in an AD clinical
study, visit http://www.clinicaltrials.gov/
(search for "Alzheimer's disease" trials), or visit
the ADEAR Center website at http://www.alzheimers.org.
The public and health professionals may also contact ADEAR toll
free at 1-800-438-4380. The ADEAR Center is sponsored by the NIA
to provide information to the public and health professionals about
AD and age-related cognitive change.
* A grant to fund the project was awarded
to the Northern California Institute for Research and Education (NCIRE),
a foundation affiliated with the Department of Veterans Affairs. Dr.
Weiner of the Veterans Affairs Medical Center in San Francisco and
the University of California at San Francisco, is Principal Investigator
for the Initiative. A Coordinating Center for the nationwide, multi-site
study will be located at the University of California at San Diego
under the direction of Leon J. Thal, M.D.
Attachment: Alzheimer's Disease Neuroimaging Initiative Questions
and Answers (http://www.nia.nih.gov/NewsAndEvents/PressReleases/ADNIQandA.htm)