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FDA nears approval for Alzheimer's brain scan

FDA nears approval for Alzheimer's brain scan

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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.

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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Andrew Nusca

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Andrew Nusca is editor of SmartPlanet and an associate editor for ZDNet. Previously, he worked at Money, Men's Vogue and Popular Mechanics magazines. He holds degrees from the Columbia University Graduate School of Journalism and New York University. He is based in New York but resides in Philadelphia. Follow him on Twitter. Disclosure