artistic design of a patient's brain cells affected by Alzheimer's disease.
Image courtesy of the National Institute on Aging / National Institutes of Health
on Friday, the US Food and Drug Administration (FDA) approved a radioactive compound to assess people with cognitive impairment of Alzheimer's disease. The drug called Amyvid, binds to amyloid plaques, the calling card of Alzheimer's disease in the brain. When administered before a PET scan, Amyvid allows doctors to see if amyloid began to build. A negative test reduces the likelihood of cognitive problems a patient is due to Alzheimer's disease, the FDA said in its letter of approval, but a positive test does not necessarily confirm a diagnosis of Alzheimer's disease .
The compound was developed by Avid Radiopharmaceuticals, which was acquired by Eli Lilly and Company in 2010. Last year, a committee of the FDA decided to hold off on the Amyvid approval pending more convincing evidence that different doctors constantly read the scans. Lilly then developed an online training course for neuroradiologists to ensure consistent readings.
Amyvid was used in the research, including clinical trials, for years, said Michael Weiner, a neurologist at the University of California, San Francisco, and lead investigator of the disease neuroimaging initiative Alzheimer. The compound will be a powerful tool for clinicians when used in combination with other diagnostic tests, said Weiner. But there are potential drawbacks, too. "There are a lot of concerns. It might be overused in general, it could be misused and there will be false diagnoses, both false positives and false negatives," says Weiner "The medical community will have to develop its own standards on how to use it. "
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