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Use Biomarkers in Alzheimer's Disease Clinical Trials, Says Expert Group
Date:1/4/2012

WASHINGTON, Jan. 4, 2012 /PRNewswire-USNewswire/ -- A group of thought leaders in Alzheimer's disease says the science is solid and the time has come for more widespread use of biomarkers in Alzheimer disease (AD) clinical trials, to speed the identification of effective disease-modifying treatments for this incurable disorder. Recommendations by the Alzheimer's Disease Biomarker Expert Working Group, convened by the not-for-profit Alliance for Aging Research in cooperation with the Food and Drug Administration, are published this month in a special issue of Neurobiology of Aging.

Co-chaired by Dr. John C. Morris of Washington University, St. Louis, and Dr. Dennis J. Selkoe of Harvard, the Working Group systematically examined published research and determined the current status of biomarkers for AD, their potential for use in the design and conduct of clinical trials, and additional data that might be needed to fully establish their usefulness.

"The commissioned papers in this peer-reviewed journal provide a way forward to the FDA and to industry in the use of biomarkers in AD trials," said Dr. Morris, professor of neurology at the Washington University School of Medicine.  "Our consensus is that certain available AD biomarkers have been sufficiently studied and validated in many populations and can be strongly recommended for use in clinical trials," he said.

Morris and Selkoe noted that the benefits of using AD biomarkers in clinical trials include a greater precision than cognitive assessment tools in measuring dementia progression, requiring fewer participants studied for less time and reducing the cost of trials. Biomarkers can allow for selective enrollment of "relatively rapid decliners," meaning fewer participants and less time to demonstrate treatment effect. They also said biomarkers enhance an investigator's confidence that patients are accurately diagnosed with AD.

"We view this white paper as representing a
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SOURCE Alliance for Aging Research
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