|Early Results from Alzheimer’s Neuroimaging
Biomarker Project Show Promise for Faster Study of Therapies
ADNI Database Now Available to Researchers Worldwide
Alzheimer’s disease researchers may be able to reduce the time
and expense associated with clinical trials, according to early
results from the Alzheimer’s Disease Neuroimaging Initiative (ADNI),
a public-private research partnership organized by the National
Institutes of Health. Preliminary results from ADNI show how it
might yield improved methods and uniform standards for imaging
and biomarker analysis, so these techniques can be employed in
the fight against Alzheimer’s disease.
These first findings will be presented at the Alzheimer’s Association
International Conference on the Prevention of Dementia being held
in Washington, D.C., June 9-12.
The ADNI study observes and tracks changes in normal individuals,
in people with mild cognitive impairment — a condition which
often precedes Alzheimer’s — and in people with Alzheimer’s.
Researchers will use PET (positron emission tomography) and MRI
(magnetic resonance imaging) scans to track changes in the brain,
laboratory analyses of cerebrospinal fluid and blood to study biomarkers,
and clinical interviews to track cognitive performance over time.
ADNI is expected to improve neuroimaging and biomarker measures
and consequently allow faster and more efficient evaluation of
potential therapies for Alzheimer’s.
The $60 million, five-year study began recruiting in early 2006,
and today about 800 older people at 58 sites in the United States
and Canada participate in the effort. The project is supported
primarily by the National Institute on Aging (NIA), a component
of NIH, with private sector support from pharmaceutical companies,
other organizations and the Alzheimer’s Association through the
Foundation for NIH. In addition to NIA, other federal partners
are the National Institute of Biomedical Imaging and Bioengineering,
also part of NIH, and the Food and Drug Administration.
“New treatment options are urgently needed for the millions of
people who have Alzheimer’s and for those at risk as the population
ages,” says Richard J. Hodes, M.D. Director of the NIA. “This preliminary
report on aspects of ADNI is quite encouraging.”
ADNI principal investigator Michael Weiner, M.D., of the Department
of Veterans Affairs Medical Center, University of California, San
Francisco, is scheduled to give a progress report and describe
the new ADNI database during the conference. Nine other ADNI researchers
will also give reports on early results and preliminary findings
from various studies including:
- Predicting Alzheimer’s — A University
of California, San Diego, study found that analyses of MRI and
PET images could detect early changes in cerebral cortex thickness
in brains of people with mild cognitive impairment over a six
month period. Further study, the researchers said, would be needed
to see if the changes, with other brain measures, could predict
conversion from mild cognitive impairment to Alzheimer’s.
- Validating PET scans — A study reported
by scientists at the Banner Alzheimer’s Institute, Phoenix, Ariz.,
and colleagues compared changes over time in PET scans of glucose
metabolism in people with normal cognition, mild cognitive impairment
and Alzheimer’s. The study found that scans correlated with symptoms
of each condition and that images from different clinical sites
were comparable (or consistent). This study suggests the validity
of PET scans for use in future clinical trials.
- MRI Reliability — A Mayo Clinic, Rochester,
Minn., study found that a standard anatomical model of a brain
can be used successfully to monitor performance of MRI scanners
at many different clinical sites. This will ensure accuracy of
the MRI images produced from ADNI volunteers using 80 MRI scanners
from scores of sites over five years.
- Biomarker Analysis — University of Pennsylvania,
Philadelphia, scientists and colleagues compared analyses of
cerebrospinal fluid samples among seven laboratories. The study
evaluated differences within and among the labs’ performance.
This study will ensure that methods for measuring biomarkers
are accurate and comparable across laboratories.
An important achievement of ADNI is the creation of a publicly
accessible database available to qualified researchers worldwide.
The database contains thousands of MRI and PET scan brain images
and clinical data and will include biomarker data obtained through
blood and cerebrospinal fluid analyses. ADNI includes samples and
brain scans from 200 people with Alzheimer’s, 400 people with mild
cognitive impairment and 200 healthy people. All volunteers are
between ages 55 and 90. Confidentiality of the participants is
“The database gives ADNI researchers easy access to a huge body
of data. But its added value is its design as an international
research resource, available worldwide to other researchers interested
in neurodegenerative disease,” says Susan Molchan, M.D., NIA’s
program director for ADNI.
To date, more than 200 researchers have signed up for database
access. Investigators may apply for access to ADNI data through
the database Web site, http://www.loni.ucla.edu/ADNI.
In addition, qualified scientists may also ask for access to the
cerebrospinal fluid and blood samples. An application form is available
under the “Scientist Home Page” link at http://www.adni-info.org/.
Partnership with private-sector funders is managed through the
not-for-profit Foundation for the National Institutes of Health,
established by the U.S. Congress to support NIH’s mission by facilitating
private-sector organizations’ support of and involvement with NIH
programs. Corporate and non-profit participants are: Pfizer Inc;
Wyeth Research; Bristol-Myers Squibb; Eli Lilly and Company; GlaxoSmithKline;
Merck & Co., Inc.; AstraZeneca AB; Novartis Pharmaceuticals Corporation;
Eisai Global Clinical Development; the Alzheimer’s Association;
Elan Corporation, plc; Innogenetics; GE Healthcare; and the Institute
for the Study of Aging. More information on the Foundation for
NIH is available at: www.fnih.org.
The Alzheimer’s Association is the first and largest voluntary
health organization for Alzheimer’s disease. The association provides
information and care consultation; offers services for families;
funds research; and is a leader in public policy regarding the
disease. For more information, visit www.alz.org.
NIA leads the federal effort supporting and conducting research
on aging and the medical, social and behavioral issues of older
people, including Alzheimer’s disease and age-related cognitive
decline. For information on dementia and aging, please visit NIA’s
Alzheimer’s Disease Education and Referral Center at www.nia.nih.gov/alzheimers,
or call 1-800-438-4380. For more general information on research
and aging, go to www.nia.nih.gov.
The National Institutes of Health (NIH) — The Nation's
Medical Research Agency — includes 27 Institutes and
Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting
and supporting basic, clinical and translational medical research,
and it investigates the causes, treatments, and cures for both
common and rare diseases. For more information about NIH and
its programs, visit www.nih.gov.