Food and Drug Administration (FDA) Outlines Path to Test Alzheimer’s Drugs Earlier
Proposed U.S. 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 The draft guidance document, issued
by the FDA, 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. Current Alzheimer's drugs treat symptoms, but none has
been proven to interrupt the steady destructive course of Alzheimer's that robs
sufferers of their memories and independence.