GE Healthcare today announced the preliminary results of two Phase 3 studies of its investigational PET amyloid imaging agent, [18F]flutemetamol, where both studies met their primary endpoints. One study, in terminally ill patients who agreed to undergo brain autopsy, showed strong concordance between flutemetamol PET images and Alzheimer's disease-associated beta amyloid brain pathology. The other study, in young healthy volunteers under age 40, had results concordant with the known lack of brain amyloid in this population. Full results of these studies will be presented in the coming months. [18F]Flutemetamol is a GE Healthcare PET imaging agent in development for the detection of beta amyloid.
"The ability to detect or exclude significant amyloid deposits in the brain, along with other diagnostic tests, may help physicians make a more accurate assessment of patients with suspected Alzheimer's disease and other cognitive disorders. The results from these studies are quite encouraging in demonstrating the potential of flutemetamol in that regard," said Carl Sadowsky, MD, Clinical Professor of Neurology at Nova Southeastern University Ft. Lauderdale, FL. "We need an accurate diagnosis and better treatment, as accurate diagnosis has the potential to enable better patient management, and may also save cost."
The accumulation of beta amyloid in the brain is believed to play a role leading up to the degeneration of neurons in Alzheimer's disease (AD) and is one of several pathological characteristics implicated in the development of AD. Currently, AD is confirmed by histopathological identification of core features, including beta amyloid plaques, in post-mortem brain samples. Targeted amyloid imaging agents are being studied to determine their ability to help physicians detect amyloid deposition in living humans.
"Flutemetamol may well prove to be a clinically valuable component of a broader diagnostic workup that neurologists use when assessing patients with cognitive impairments, who may have AD," said Jonathan Allis, MI PET Segment Leader, GE Healthcare Medical Diagnostics. "These studies support our application for regulatory approval of [18F]flutemetamol, and we intend to file later this year."
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