The U.S. Food and Drug Administration has approved a radiopharmaceutical for use with positron emission tomography
to image the brain in adults being evaluated for Alzheimer’s disease and dementia.
Vizamyl (flutemetamol F-18 injection) attaches to beta-amyloid deposits, the abnormal protein that is associated with dementia caused by Alzheimer’s. The resulting PET color scan can identify the presence of the protein. A positive scan points to moderate-or-greater presence of beta amyloid in the brain, while negative scans indicate little or no accumulation of beta amyloid.
The drug’s effectiveness was verified by two clinical studies of 384 participants with a range of cognitive function. All participants were injected with Vizamyl and scanned, and five independent radiologists blind to the study data interpreted the images.
According to the FDA, Vizamyl is not indicated to predict the development of Alzheimer’s or to determine how patients respond to treatment of Alzheimer’s, and it does not replace other existing diagnostic tests for the disease.
Vizamyl is the second PET imaging agent approved by the FDA for Alzheimer’s disease evaluation.