Cognition Therapeutics, Inc. received final minutes from the U.S. Food and Drug Administration (FDA) confirming alignment on the proposed design of the Phase 3 program for zervimesine (CT1812) as a treatment for Alzheimer’s disease. This follows the end-of-Phase 2 meeting held on July 9, 2025.
The FDA concurred with the company's plan to enrich the Phase 3 study population by enrolling adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening. Previous clinical experience showed zervimesine arrested cognitive deterioration by 95% in this population, supporting p-tau217 as a predictive biomarker.
A key outcome was the FDA’s view that two six-month Phase 3 studies could support a New Drug Application (NDA) for zervimesine. This design is expected to allow for faster, more cost-effective studies, potentially bringing the drug to a regulatory filing sooner. Participants will be randomized to 100mg oral zervimesine or placebo daily for six months, with efficacy and safety endpoints affirmed by the FDA.
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