US FDA outlines path to test Alzheimer's drugs earlier

By REUTERS
February 8, 2013 00:35

CHICAGO - Proposed US guidelines may make it easier for drug companies to test Alzheimer's treatments in people at an earlier stage, when scientists think they may have the best shot at working.

The draft guidance document, issued on Thursday by the US Food and Drug Administration, reflects changes in scientists' understanding of Alzheimer's. They now believe the disease begins at least a decade before symptoms appear.

"The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," said Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.


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