Columbia Seeks People Aged 55-90 For National Alzheimerï¾’S Disease Study
New York, NY (May 25, 2006) – Researchers at Columbia University Medical Center are looking for men and women aged 55 to 90 to participate in a study designed to speed the development of new treatments for Alzheimer’s disease.
The study is currently enrolling three types of participants: people who have been diagnosed with Alzheimer’s within the last year; people newly diagnosed with mild cognitive impairment (MCI); and people with no known memory complaints, or at least no more than the normal memory problems associated with advancing age. Selected participants will be assessed every 6 months for 2 to 3 years and will be compensated for their time.
Columbia University Medical Center is one site taking part in the national Alzheimer’s Disease Neuroimaging Initiative (ADNI), a unique partnership sponsored by the National Institutes of Health (NIH), with major support from the private sector. The initiative is being undertaken to find the most effective methods for tracking physical changes in the brain and in body fluids during the course of Alzheimer’s disease and to establish those methods as clinical standards. These standards would then be used during clinical trials to assess the effectiveness of new Alzheimer’s medications, which in turn could lead to more efficient trials and faster approval of medications. Researchers emphasize that these standards are urgently needed to facilitate clinical trials as potential Alzheimer’s drugs become ready for human testing.
“There are a number of new drugs under development for the treatment of Alzheimer’s, but how do you evaluate their effectiveness in patients?” said Michael Weiner, M.D., principal investigator of the study. Weiner directs the Magnetic Resonance Spectroscopy Unit at the San Francisco VA Medical Center (SFVAMC), and is professor of radiology, medicine, psychiatry, and neurology at the University of California, San Francisco (UCSF).
Currently, the evaluation of people with memory problems or Alzheimer’s disease includes a battery of neuropsychological tests of memory, thinking, and behavior. These tests take considerable time to conduct and must be administered repeatedly over a period of time for accurate diagnosis. Physical measures, including brain size, brain activity, the presence of certain proteins in the brain, or biomarkers in blood or cerebrospinal fluids, may be able to detect Alzheimer’s-related changes sooner than these tests, possibly well before the signs and symptoms of the disease become evident in a person’s day-to-day life.
In the Alzheimer’s Disease Neuroimaging Initiative, magnetic resonance imaging (MRI) and positron emission tomography (PET) will be used to directly measure changes in brain structures. Blood and cerebrospinal fluid, which contain brain chemicals, will be tested as indirect indicators of change. Research suggests that MRI and PET may have value in tracking pathological changes in the brain and potentially in predicting Alzheimer’s disease; however, Weiner noted, there has never been a single study comparing imaging methods to each other, to biological markers in blood and spinal fluid, and to the standard clinical and neuropsychological tests over several years.
Nationwide, the ADNI study aims to recruit a total of 200 people with Alzheimer’s, 400 people with MCI, and 200 people with no known cognitive problems. They will be studied at over 60 medical centers across the U.S. and Canada. People with MCI and with no cognitive problems will be studied for 3 years, and people with Alzheimer’s for 2 years.
“Once data is collected from the 60 sites, my colleagues and I will run a statistical analysis developed at Columbia, to improve diagnosis based on abnormalities found with the MRI and PET,” said Yaakov Stern, Ph.D., professor of clinical neuropsychology and director of the Cognitive Neuroscience Division, Gertrude H. Sergievsky Center and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Medical Center. “This trial is so important for the field of Alzheimer's, as the findings should help eliminate much of the confusion about diagnoses – for both patients and physicians.”
Every 6 months over the course of the study, every participant will receive standard neuropsychological testing, blood and urine tests, and an MRI scan at a strength of 1.5 Tesla, the strength of most MRI scanners commonly in use in the United States. In addition, half of the participants will be randomly assigned to receive a PET scan at the same time. Fifty percent of the remaining half, or 25 percent of the total, will be randomly assigned to receive an MRI scan at the higher-resolution strength of 3 Tesla at regular intervals. The other 25 percent will be randomly assigned to receive analysis of their cerebrospinal fluid when they enter the study and at 12 months.
“The goal of the study is to provide researchers with better tools so that we can find a drug, demonstrate its effectiveness, and offer new treatments as soon as possible,” said Susan Molchan, M.D., director of the Alzheimer’s Disease Clinical Trials Program at the National Institute on Aging at NIH, which spearheads the effort. Molchan pointed out that the data and samples from the study will be made available to qualified researchers in government, academia, and the pharmaceutical industry so that analyses can be done as quickly as possible.
Anyone aged 55 to 90 who is interested in participating in the study should call toll-free 1-800-438-4380. Or, to participate in the Columbia University Medical Center site, you may contact study coordinators Rebecca Torgan at 212-305-1987 or Karina Stavintky at 212-342-0522.
ADNI co-investigators include Leon Thal, M.D., of the University of California, San Diego; Ronald Petersen, M.D., Ph.D., and Clifford Jack, M.D., of the Mayo Clinic, Rochester, Minn.; William Jagust, M.D., of the University of California, Berkeley; John Q. Trojanowski, M.D., Ph.D., of the University of Pennsylvania; Arthur W. Toga, Ph.D., of the University of California, Los Angeles; and Laurel Beckett, Ph.D., of the University of California, Davis.
The research is funded by a grant from the National Institute on Aging, with additional support from the National Institute of Biomedical Imaging and Bioengineering, both parts of the NIH at the U.S. Department of Health and Human Services. Private sector participation is managed by the Foundation for the National Institutes of Health, with contributions from Pfizer Inc., Wyeth Research, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Merck & Co., Inc., AstraZeneca AB, Novartis Pharmaceuticals Corporation, Eisai Global Clinical Development, Alzheimer’s Association, Elan Corporation, plc, Forest Laboratories, and the Institute for the Study of Aging. The U.S. Food and Drug Administration is also participating in the study. Research funding is administered by the Northern California Institute for Research and Education (NCIRE), and the study is coordinated by the Alzheimer’s Disease Cooperative Study at the University of California, San Diego.
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