Phase 3 Trial Update of Flutemetamol for PET Amyloid Imaging

GE Healthcare announced the final results from a Phase 3 study of the investigational PET amyloid imaging agent, [18F]flutemetamol in terminally ill patients who had agreed to undergo postmortem brain autopsy; the data showed strong concordance (sensitivity and specificity) between [18F]flutemetamol PET images and beta amyloid brain histopathology. These data confirm the potential of [18F]flutemetamol as an imaging agent to detect beta amyloid plaque, a pathology associated with Alzheimer's disease (AD), in living patients.

The study examined the autopsied brains of 68 subjects who had received [18F]flutemetamol imaging in life to detect the presence of brain beta amyloid pathology. The images were then evaluated visually by independent trained readers, and the flutemetamol retention in the brain was quantified using a standardized uptake value ratio (SUVR). The brains of subjects who subsequently died were evaluated histopathologically and compared to interpretations of flutemetamol PET scans.

[18F]Flutemetamol showed the ability to detect beta amyloid with a majority read sensitivity of 86% and specificity of 92%. Sensitivity is the percentage of amyloid-positive brains that are correctly identified by [18F]]flutemetamol image readers as abnormal, corresponding to positive amyloid pathology. Comparison within and between image readers documented strong consistency of interpretation.

 [18F]flutemetamol is being studied to determine its ability to detect amyloid deposition for a more accurate assessment of patients with suspected Alzheimer's disease and other cognitive disorders.

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