PET Amyloid Imaging Agent Shows Promise for Alzheimer’s Detection

Preliminary findings of two phase 3 studies of an investigational positron emission tomography (PET) amyloid imaging agent, 18F-flutemetamol, showed that both studies met their primary objectives.

One study in terminally ill patients who agreed to undergo brain autopsy, showed strong concordance between flutemetamol PET images and Alzheimer’s disease (AD)-associated beta amyloid brain pathology. The other study, in young healthy volunteers under age 40, had findings 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 (Chalfont St. Giles, UK) 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 (Fort Lauderdale, FL, USA). “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 thought to play a role leading up to the deterioration of neurons in AD and is one of several pathologic characteristics implicated in the development of AD. Currently, AD is validated by histopathologic identification of core features, including beta amyloid plaques, in postmortem 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.”

18F-Flutemetamol is one component of a wide range of diagnostic products that GE Healthcare is currently developing in the AD field. GE Healthcare is taking a comprehensive approach to understanding AD through its ongoing research to uncover the causes, risks, and physical effects of the disease. For example, the company is partnering with pharmaceutical firms to identify a biosignature, or a biologic indicator, which may help physicians diagnose AD prior to the onset of clinical symptoms.

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