GE Healthcare is touting the preliminary results of two phase 3 clinical studies for its investigational PET amyloid imaging agent, flutemetamol, to detect beta amyloid in the brain.
In one study, terminally ill patients who agreed to undergo brain autopsy showed strong concordance between flutemetamol PET images and beta amyloid brain pathology associated with Alzheimer's disease. In the other study, young healthy volunteers under the age of 40 had results concordant with the known lack of brain amyloid in this population.
The accumulation of beta amyloid in the brain is believed to play a role in the degeneration of neurons in Alzheimer's disease and is one of several pathological characteristics implicated in the development of Alzheimer's.
GE plans to present complete results in the coming months and submit an application to the U.S. Food and Drug Administration for clearance of flutemetamol later this year.
