FDA Moves Closer To Approving First Alzheimer’s Detection Test For The Living

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Posted on 22nd January 2011 by Gordon Johnson in Uncategorized

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A Food and Drug Administration advisory committee has recommended that the agency approve a scan that can detect plaques — in the brain of a live person — that are markers for Alzheimer’s disease, The New York Times reported Friday.   

http://www.nytimes.com/2011/01/21/health/21alzheimers.html?src=me&ref=general

The FDA typically heeds the advice of its advisory committees, which means that it’s likely that Avid Radiopharmacueticals will win approval to market the scans. According to The Times, certain plaques are considered a medical criteria for having Alzheimer’s disease. A person who loses his or her memory is not diagnosed with Alzheimers’s unless they have the plaques.

Previously, the only way to confirm that there were plaques in a person’s brain was through an autopsy. But the new scan will permit doctors to detect the plaques in the living.

Avid, a unit of Eli Lilly & Co., has a dye tht makes plaque visible during PET scans.

Even though the is no cure for Alzheimer’s, the new scan is considered an important tool to correctly diagnosing, and manage, a patient’s illness. Doctors would learn for certain if a patient’s memory failure and other cognitive problens were being caused by Alzheimer’s or another type of disease, or from a stroke.

FDA To Consider How Important Tests Are for Alzheimer’s, A Disease With No Cure

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Posted on 20th January 2011 by Gordon Johnson in Uncategorized

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Depending on who you believe in the media, we are coming closer to having methods to determine if someone has Alzheimer’s disease — or federal regulators are unimpressed with at least one of the potential solutions.

The New York Times Wednesday ran an upbeat story with the headline “Two Tests Could Aid In Risk Assessment And Early Diagnosis of Alzheimer’s.”    

http://www.nytimes.com/2011/01/19/health/research/19alzheimers.html?_r=1&ref=us

The Times noted that one new study had evaluated a new kind of brain scan that detects the plaques in the brain that are characteristic of Alzheimers’. On Thursday a Food and Drug Administration committee is scheduled to review that study and recommend whether that test should get the go-ahead to be marketed.

The new brain scan involves what The Times described as a dye created by Avid Radiopharmaceuticals, which is part of Eli Lilly & Co. That dye is supposed to attach to the plaque in the brain, beta amyloid, “lighting” it up so that it becomes visible in PET scans.

In contrast to the upbeat report in The Times, The Wall Street Journal said the dye that finds plaque, which it named as the drug Amyvid, was being given a dim eye by the FDA committee. The Journal, in a story headlined “FDA Skeptical About Detecting Alzheimer’s,” reported that two FDA reviewers are recommending that Amyvid not be approved.     

http://online.wsj.com/article/SB10001424052748704678004576090320296403228.html?KEYWORDS=alzheimer%27s

At least two FDA reviewers questioned the need for the new scan since there isn’t even a cure for Alzheimer’s yet. And according to The Journal, the first question the FDA will be asked to address Thursday is “whether knowledge of brain amyloid plaque would have ‘clinical usefulness.'” 

 

A second study investigated whether a blood test can detect the presence of the protein that comprises Alzheimer’s plaque, beta amyloid, according to The Times. 

The studies were reported Wednesday in The Journal of the American Medical Association.     

http://jama.ama-assn.org/content/305/3/261.full