Volunteers are being sought for a clinical study examining the subtle changes that may take place in the brains of older people many years before overt symptoms of Alzheimer’s disease appear. Researchers are looking for people with the very earliest complaints of memory problems that affect their daily activities. The study will follow participants over time, using imaging techniques developed to advance research into changes taking place in the structure and function of the living brain, as well as biomarker measures found in blood and cerebrospinal fluid.
The National Institute on Aging (NIA), part of the National Institutes of Health, and the NIH Office of the Director are funding the $24 million, two-year Alzheimer’s Disease Neuroimaging Initiative Grand Opportunity (ADNI-GO) study. Researchers seek to recruit 200 volunteers between the ages of 55 and 90 who may be transitioning from normal cognitive aging to an early stage of amnestic mild cognitive impairment (aMCI), a condition that may progress to Alzheimer’s disease. Participants may volunteer at 51 sites across the United States.
“ADNI-GO is part of an ongoing effort to establish imaging and fluid biomarker measures of Alzheimer’s disease from the onset of mild symptoms to the advanced stages of the disease process,” said NIA Director Richard J. Hodes, M.D. “By advancing understanding of the full spectrum of the disease, we’ll be better able to identify who is at risk, track progression of the disorder, and devise measurements to test the effectiveness of potential prevention or treatment strategies.”
The grant expands the efforts of the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a research partnership supported primarily by the NIA with private-sector support through the Foundation for the National Institutes of Health ADNI began in 2004 to establish neuroimaging and biomarker measures to track the changes taking place in the brains of 800 older people either free of symptoms or diagnosed with late-stage MCI and early Alzheimer’s disease. ADNI is led by the Northern California Institute for Research and Education, a nonprofit foundation affiliated with the San Francisco VA Medical Center. Michael Weiner, M.D., is the principal investigator.
The new ADNI-GO effort enables researchers to continue studying nearly 500 of the original ADNI volunteers, while expanding the study to include the new participants with early amnestic MCI. Newly enrolled participants and some original study volunteers will undergo a lumbar puncture to collect cerebrospinal fluids.
“The objective of ADNI-GO is to add to the power of the original study by increasing our knowledge of the sequence and timing of events involved in the disease from its earliest measureable point, perhaps even pre-symptomatically, to overt Alzheimer’s disease,” said Marcelle Morrison-Bogorad, Ph.D., director of NIA’s Division of Neuroscience.
The ability to gain this knowledge is only possible, Morrison-Bogorad emphasized, through the generosity of research volunteers. “The research community is deeply grateful to the volunteers, and their families and friends, who give of themselves in this search for a cure for or prevention of Alzheimer’s disease,” she said.
To volunteer or learn more about the study, contact the NIA Alzheimer’s Disease Education and Referral Center by calling 1-800-438-4380 or by going to www.nia.nih.gov/alzheimers . Volunteers must speak English or Spanish and have a person willing to assist them during at least five clinic visits and with telephone contacts from researchers.
Data from the study will be posted to a publicly accessible database available to qualified researchers worldwide. To date, more than 800 researchers have signed up for ADNI database access. Investigators may apply for access through the database Web site at www.loni.ucla.edu/ADNI  . In addition, qualified scientists may also ask for access to the cerebrospinal fluid and blood samples.
In addition to NIA, the original ADNI study involved other federal partners: the National Institute of Biomedical Imaging and Bioengineering, also part of NIH, and the U.S. Food and Drug Administration, another agency of the U.S. Department of Health and Human Services. To learn more about ADNI advances and the private-public partnership supporting the research, go to www.nia.nih.gov/newsroom/2009/03/scientists-report-important-step-biomarker-testing-alzheimers-disease .
The 51 study sites recruiting volunteers are located in:
Ann Arbor, Mich.
Kansas City, Kan.
New Haven, Conn
New York City
Palo Alto, Calif.
Sun City, Ariz.
West Palm Beach, Fla.
The NIA leads the federal government effort conducting and supporting research on the biomedical, social and behavioral issues of older people. For more information on aging-related research and the NIA, go to www.nia.nih.gov . The NIA provides information on age-related cognitive change and neurodegenerative disease specifically at its Alzheimer’s Disease Education and Referral (ADEAR) Center site at www.nia.nih.gov/alzheimers . To sign up for e-mail alerts about new findings or publications, please visit either website.
FNIH was established by the United States Congress to support the mission of the National Institutes of Health—improving health through scientific discovery. The foundation identifies and develops opportunities for innovative public-private partnerships involving industry, academia and the philanthropic community. A non-profit, 501(c)(3) corporation, the foundation raises private-sector funds for a broad portfolio of unique programs that complement and enhance NIH priorities and activities. The foundation's Web site address is www.fnih.org .
The 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 .