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“Earlier and more precise identification of patients with early changes in the brain who


will go on to develop Alzheimer’s is important for the success of these clinical studies.” – Billy Dunn, M.D., a neurologist and the director of FDA’s Division of Neurology Products.


but might be at risk for developing Alzhei- mer’s, based on an advanced brain scan. The three-year study is testing whether a new investigational treatment can slow the memory loss caused by Alzheimer’s. One of the biggest challenges is correctly


identifying patients at risk for developing Alzheimer’s. In recent years, researchers have identified biomarkers (measurements, often based on a laboratory test, of a con- dition or disease) that may indicate a higher risk for developing Alzheimer’s. Some of them are gene mutations.


“In a small proportion of patients, having


someone in the family with Alzheimer’s dra- matically raises the risk that they, too, will have the disease,” Dunn says. For most people, however, the risk of Alzheimer’s is not quite as readily identified. “If we can use biomarkers to better


choose who should be in which clinical trials, these biomarkers hopefully will help increase the likelihood that we’ll be able to show the drug effect in clinical trials,” Bastings says.


Prompt detection of the disease may lead


to the development of early treatments that could help patients retain their brain func- tion for a long time, even if their underlying Alzheimer’s may not be reversed. “We’re very excited about increasing our


ability to find beneficial treatments for so many people with this devastating disease,” Dunn says.


This article was reprinted with permission from the Food and Drug Administration. It originally appeared on the FDA’s Consumer Updates page.


NEW RESEARCH UNDERWAY FOR LANDMARK ALZHEIMER’S BIOMARKER STUDY


The Alzheimer’s Disease Neuroimaging Initiative (ADNI)— the long-running National Institutes of Health-supported study investigating brain and fluid biomarkers of the disease—enters a new phase of discovery with the launch of ADNI3. With the recent NIH award of approximately $40 million over the next five years—coupled with anticipated private sector contributions of $20 million through the Foundation for the National Institutes of Health (FNIH)— ADNI3 will use cutting-edge technologies in brain imaging as it recruits hundreds of new volunteers. Expansion of the groundbreaking study, now in its 12th year, will further develop ways to speed clinical trials by providing researchers the biomarkers needed to detect the onset and track the progression of Alzheimer’s disease.


The study matches changes in clinical and cognitive testing with Alzheimer’s-related changes in biological markers detected in blood, cerebrospinal fluid and DNA samples donated by volunteers. Brain scans identify changes in brain volume, white matter integrity, functional connectivity between brain regions, glucose metabolism and the buildup of amyloid protein plaques—a hallmark of the disease. ADNI3 will add brain scans that detect tau protein tangles, another indicator of the disease. Blood, cerebrospinal fluid and DNA samples also enable scientists to better understand Alzheimer’s-related chemical changes and how genes influence the disorder.


ADNI, one of the largest public-private partnerships in Alzheimer’s disease research, is supported by the National Institute on Aging (NIA) at NIH through a grant to the nonprofit Northern California Institute for Research and Education, San Francisco.


ADNI3 recruitment began in the fall and is seeking up to 1,200 volunteers, over the age of 55, to join about 800 current participants at 60 sites in the United States and Canada. The volunteers represent the full trajectory of the disease, including those with normal cognition, mild cognitive impairment (often a precursor to Alzheimer’s), and Alzheimer’s dementia.


54 SENIOR LIVING EXECUTIVE / NOVEMBER/DECEMBER 2016


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