Approval of New Alzheimer’s Disease Dianostic Agent


The Wien Center for Alzheimer’s Disease and Memory Disorders at Mount Sinai Medical Center in Miami Beach, Florida, was one of a select few sites throughout the country chosen to participate in a clinical trial that resulted in the FDA approval of Amyvid. It is the first and only diagnostic agent approved for PET imaging of a living brain in adults under evaluation for Alzheimer’s disease (AD) and other causes of cognitive decline.

Currently, only a brain autopsy at the time of death can provide confirmation that an individual suffered from Alzheimer’s disease. However, Amyvid enables doctors to make a more definitive diagnosis in living patients.

Amyvid, which is given through an injection, binds to amyloid plaques – a hallmark characteristic of Alzheimer’s – allowing the plaques to be detected using PET scan images of the brain. Amyloid plaques are abnormal clumps of brain cells mixed with beta-amyloid protein. A negative Amyvid scan allows physicians to conclude that no amyloid plaques are present and, thus, rule out a diagnosis of Alzheimer’s.

“This tool is extremely helpful to physicians in ruling out AD as nationally one in five patients who are initially diagnosed with Alzheimer’s ultimately show no signs of the disease in a brain autopsy,” stated Dr. Ranjan Duara, medical director of The Wien Center at Mount Sinai. Dr. Duara, the principal site investigator for the clinical trial at Mount Sinai, served as the national advisor for the design and interpretation of the overall study. The Wien Center is also the home of the State of Florida Brain Bank. As such, Dr. Duara’s team at Mount Sinai also analyzed and processed all the brains in South Florida that were part of the clinical trial.

A positive scan indicates moderate to frequent plaques are present, but does not establish a diagnosis of AD; however, it does help physicians assess their patients by serving as an adjunct to other diagnostic evaluations.

“As many as 30 percent of cognitively normal elderly people over the age of 70 may have a positive scan. This means they may be at an increased risk for developing Alzheimer’s disease,” said Duara. “That is why the development of Amyvid is a major advance in the battle against Alzheimer’s. It allows us to potentially intervene before symptoms of the disease surface.”

Beginning June of 2012, a limited number of radiopharmacies will be distributing Amyvid with increased distribution toward the end of the year. Mount Sinai will potentially be one of the South Florida sites that will have Amyvid available as a diagnostic agent.

For more information on The Wien Center for Alzheimer’s Disease and Memory Disorders at Mount Sinai Medical Center, please visit or call 305-674-CARE (2273).

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