Alzheimer’s Disease Neuroimaging Study Launched Nationwide by the National Institutes of Health

The Alzheimer’s Disease Neuroimaging Initiative (ADNI) — a project developed by the National Institutes of Health (NIH) — is seeking 800 older adults to participate in a study aimed at identifying biological markers of memory decline and Alzheimer’s disease (AD). Ultimately, scientists hope that brain and biological changes can be detected before memory decline and other symptoms appear, allowing the effectiveness of drugs to be evaluated at the earliest possible time.

The $60 million, 5-year ADNI study is the most comprehensive effort to date to identify brain and other biological changes associated with memory decline. The project was begun by the National Institute on Aging (NIA) and is supported by more than a dozen other federal agencies and private-sector companies and organizations. Investigators at 58 local study sites across the U.S. and Canada will be asking people ages 55 to 90 to become a part of this landmark research.

“We encourage people to participate in this important study because it will help us to identify needed biological markers of memory decline and Alzheimer’s disease. These biomarkers could become comparable to the cholesterol measures now used as biomarkers for heart disease,” says Susan Molchan, M.D., program director for the ADNI project at the NIA. “In addition, using what we learn from the brain scans and other tests, we hope to lessen the time and cost of testing drugs and to bring treatments to patients much sooner.”

Scientists are looking for new ways to measure changes in the brain that occur with normal aging and with the progression of mild cognitive impairment (MCI), a subtle but measurable transitional state between the cognitive changes of normal aging and very early AD. People with MCI have memory impairments but otherwise function well and do not meet clinical criteria for dementia.

The ADNI researchers will employ serial magnetic resonance imaging (MRI); positron emission tomography (PET) scans; measurement of various biological compounds in blood, cerebrospinal fluid, and urine; and clinical and neuropsychological assessments to track MCI and early AD progression. MRI and PET scans are used in both medical practice and research to produce images of the brain.

The study’s principal investigator (PI) is neuroimaging expert Michael W. Weiner, M.D., of the San Francisco Veterans Affairs Medical Center and the University of California, San Francisco. The Northern California Institute for Research and Education, a foundation affiliated with the U.S. Department of Veterans Affairs, has been awarded the multi-center ADNI grant.

Weiner explains that the 800 adults ages 55 to 90 sought for the study will be divided into three groups — approximately 200 cognitively normal older people will be followed for 3 years, 400 people with MCI will be followed for 3 years, and 200 people with early AD will be followed for 2 years. At the end of the study, the researchers will compare neuroimaging, biological, and clinical information from the participants, looking for correlations among the data to develop standards for tracking the progression of memory decline. A unique feature of the project is the development of an imaging and biomarker database that can be tapped by researchers in both the public and private sectors as they develop and test drugs for memory decline.

“Our goal is to ‘see’ critical brain changes and to identify biochemical indicators that may be useful in evaluating treatments aimed at slowing memory decline and AD,” explains Weiner.

A special aspect of the project is the support of Dr. Maya Angelou, the eminent poet, author, educator, and historian. Dr. Angelou, a professor at Wake Forest University in Winston-Salem, NC, is working with the researchers to ask the public to take part in the study through the national ADNI recruitment outreach campaign, “Imagine Stopping the Progression of Alzheimer’s Disease,” in which she will appear in radio and print public service announcements. She has a number of dear friends who have suffered the effects of AD.

ADNI is the largest public-private partnership on brain research underway at the NIH, U.S. Department of Health and Human Services (DHHS). In addition to the NIA, the Federal ADNI partners are the National Institute of Biomedical Imaging and Bioengineering, also part of NIH, and the U.S. Food and Drug Administration, another DHHS agency.

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; and the Institute for the Study of Aging. (More information on the Foundation for NIH is available at: www.fnih.org.)

Siemens, Philips, and General Electric, the three primary companies that develop and manufacture imaging equipment, are providing software support for the imaging aspects of the project.

Other investigators for the project are Leon Thal, M.D., University of California at San Diego, (Coordinating Center), Ronald Petersen, M.D., Ph.D., of the Mayo Clinic, Rochester, MN (Clinical Aspects), Clifford Jack, M.D., Mayo Clinic (Neuroimaging/MRI Core);

William Jagust, M.D., University of California, Berkeley (Neuroimaging/PET Core); John Q. Trojanowski, M.D., Ph.D., University of Pennsylvania (Biomarker Core); Arthur W. Toga, Ph.D., University of California, Los Angeles (Bioinformatics Core); and Laurel Beckett, Ph.D., University of California, Davis (Biostatistics Core). In addition, there are investigators at all of the study sites throughout the United States and Canada.

The public can find out more about participating in the research and obtain a list of study sites by contacting the NIA’s Alzheimer’s Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by visiting the ADNI section of the ADEAR website: www.alzheimers.org/imagine. Those interested in participating in the project are encouraged to contact the study site closest to them. Spanish-language capabilities are available at some of the study sites.

An estimated 4.5 million people in the U.S. have AD, the most common cause of dementia, and the number is rising as baby boomers enter their older years.

The NIA leads the Federal effort in research on AD and age-related cognitive change. For more information on participation in a number of clinical studies on AD, visit www.clinicaltrials.gov (search for “Alzheimer’s disease” trials) or the ADEAR Center website at www.alzheimers.org, or contact ADEAR toll free at 1-800-438-4380. The ADEAR Center also provides information to the public and health care professionals about AD and age-related cognitive change.