COLUMBUS, Ohio – The Ohio State University Medical Center will participate in a new $60 million, five-year national project exploring whether a series of neuroimaging tests, other biological markers and neuropsychological assessments can be combined to more effectively measure the progression of mild cognitive impairment and early Alzheimer’s disease.
The study, a public-private partnership announced today by the National Institute on Aging (NIA), is designed to help researchers and clinicians develop new treatments for Alzheimer’s disease and monitor their effectiveness, as well as reduce the time and cost of clinical trials. The project is the most comprehensive effort to date to find neuroimaging and other biomarkers – biochemical indicators that can be used to measure disease progress or effects of treatment – for the cognitive changes associated with mild cognitive impairment and Alzheimer’s disease.
Identifying biomarkers and standardizing neuroimaging methods could provide a better way to compare results from different studies, a major goal of the initiative. Previous research has suggested that neuroimaging may serve as a more sensitive and consistent measure of disease progression than the neuropsychological and cognitive assessments typically used in research and clinical practice, and that some biological tests also may contain markers for dementia.
Federal health agencies are joining forces with a number of private and corporate partners in funding the initiative, with an estimated third of the funding coming from pharmaceutical companies.
Dr. Douglas Scharre, director of the division of cognitive neurology at OSU Medical Center, will lead Ohio State’s participation in the initiative. OSU is one of approximately 50 sites across the United States and Canada that will screen patients for the initiative.
“This is an exciting project, and it may be a sign of the future where academia-derived research is partly supported by industry partnerships through the NIA,” Scharre said. “In this study, we’ll be looking at markers for Alzheimer’s disease rather than at the effects of a specific drug.”
Scharre also said the study’s design represents a break from tradition by making all clinical, imaging and biological data available to the public as information is collected.
“Researchers will be able to use data quickly. Access is going to be almost up-to-the-minute,” he said. “Large tissue data banks will be made available so other investigators could come in and design additional research. These data will provide impetus for research that could stretch out for many years.”
Scharre has led or been involved in a number of published studies of specific medications’ effects on Alzheimer’s disease patients, and developed a test several years ago to assess Alzheimer’s patients’ ability to continue driving. He also is medical director of the neurobehavior and memory disorders clinics at OSU Medical Center.
Alzheimer’s disease is an irreversible disorder of the brain and the most common cause of dementia in people over age 65, affecting an estimated 4.5 million Americans. People with mild cognitive impairment have ongoing memory problems, but are able to maintain daily activities.
This national study, called the Alzheimer’s Disease Neuroimaging Initiative, will begin screening participants in April 2005. About 800 adults, ages 55 to 90, will be recruited to participate – approximately 200 cognitively normal older individuals to be followed for three years, 400 people with mild cognitive impairment to be followed for three years, and 200 people with early Alzheimer’s disease to be followed for two 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 (positron emission tomography) or MRI (magnetic resonance imaging) can provide clearer measures of disease progression than assessments currently used to evaluate patients.
As mild cognitive impairment and Alzheimer’s progress, for example, areas of the brain involved with memory, such as the hippocampus, 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 Alzheimer’s 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 and urine samples.
Scharre said details of each site’s role in the study have not been finalized, but OSU Medical Center has PET and MRI capabilities, including one MRI machine that doubles the magnetic strength of the most commonly used MRI scanners. The medical center also houses a cerebrospinal fluid tissue bank. Other cognitive neurology specialists and radiology researchers will partner with Scharre on the work at OSU.
The NIA, part of the National Institutes of Health, is joined in this initiative by the National Institute of Biomedical Imaging and Bioengineering and the Food and Drug Administration. More than a third of the initiative will be funded by contributions from Pfizer Inc., Wyeth Research, Eli Lily and Co., Merck & Co. Inc., GlaxoSmithKline, AstraZeneca AB, Novartis Pharmaceuticals Corp., Eisai Global Clinical Development, Elan Corp. and the Institute for the Study of Aging. The Alzheimer’s Association also is participating.
Those interested in participating in the study can contact the NIA’s Alzheimer’s Disease Education and Referral (ADEAR) Center at 800-438-4380 for more information. # # #
Medical Center Communications