FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says
Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.
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The Phase III failure of the Alzheimer’s treatment was largely expected, but is nonetheless a disappointment for the disease and for the anti-amyloid field, casting a shadow over other therapies in development, including Lilly’s own pipeline.
Gold standard outcome for Alzheimer's trials may have its difficulties, especially with rater error, but experts say there's no proven alternative to ADAS-cog.
Alzheimer’s R&D has suffered multiple failures over the last decade, with no drug found to slow or halt the underlying progression of the disease. Industry’s focus is now on patients at the very earliest stages of Alzheimer’s in the hopes of finding an effective drug before too much damage is done. FDA is meeting sponsors halfway, with a draft guidance outlining approval requirements.