FDA nears approval for Alzheimer's brain scan

The U.S. FDA is nearing approval of a diagnostic scan for Alzheimer's disease that can reveal how much plaque is in the brain.
Written by Andrew Nusca, Contributor

The U.S. Food and Drug Administration on Thursday took a step closer to approving the first test for Alzheimer's disease after an advisory committee recommended that the agency approve it.

The test, a brain scan, is designed to reveal the brain plaques that build in the brain of some 5 million living Americans. Those plaques cause memory problems, the disease's signature trait.

Currently, the plaques can only be assessed during an autopsy.

Philadelphia, Penn.-basedAvid Radiopharmaceuticals applied to market the scans. The approval -- which is not for the PET test itself, but a dye that gravitates toward plaque in the brain --  is contingent on agreement among radiologists on how to read the scans properly.

(Specifically, the radiologists want to determine what level of plaque is "significant" enough to warrant a diagnosis.)

A treatment or cure for Alzheimer's remains elusive, but a diagnostic and imaging solution is a step toward understanding the disease.

F.D.A. Sees Promise in Alzheimer's Imaging Drug [NYT]

Association of Plasma β-Amyloid Level  and Cognitive Reserve With Subsequent Cognitive Decline [JAMA]

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