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.-based Avid 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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