Piramal imaging announced that the FDA has approved Neuraceq (florbetaben F18 injection) for the positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
The FDA approval is based on safety data from 872 patients from global clinical trials, including 205 end-of-life patients who agreed to a post-mortem brain donation program. The studies analyzed brain images (n=82) with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. The visual PET interpretation with histopathology in these brain images showed that Neuraceq accurately detected moderate to frequent beta-amyloid neuritic plaques in the rain. This suggests Neuraceq may be a helpful tool to estimate the plaque densities.
A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of Alzheimer’s disease at the time of imaging. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques that may be present with Alzheimer’s disease and other types of neurologic conditions.
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