Cognition Therapeutics, Inc. is a biopharmaceutical company in the clinical stage, focused on identifying and advancing small molecule treatments. The firm's research and development efforts are primarily directed towards age-related neurodegenerative conditions affecting the central nervous system, as well as retinal disorders. Its most advanced experimental therapy is CT1812, which acts as a sigma-2 receptor antagonist. This compound is currently being evaluated in Phase II clinical trials for the management of mild-to-moderate Alzheimer's disease and dementia with Lewy bodies (DLB). Additionally, it has successfully concluded Phase I trials for early-stage Alzheimer's and is undergoing preclinical investigation for dry age-related macular degeneration (AMD). The company's pipeline also includes CT2168, a treatment candidate for synucleinopathies—a category of diseases encompassing DLB and Parkinson's disease—and CT2074, which is in development for dry AMD. Cognition Therapeutics, Inc. was established in 2007 and operates from its headquarters in Purchase, New York.
Cognition Therapeutics Schedules a Type C Meeting with FDA to Align on Endpoints for Phase 3 Trial of Zervimesine (CT1812) in DLB
Cognition Therapeutics scheduled a Type C meeting with the FDA Division of Neurology for October 20, 2026, to align on the primary endpoint for a planned registrational Phase 3 trial of zervimesine (CT1812) in dementia with Lewy bodies with psychosis.
FDA minutes from June 2026 already supported measuring psychosis as a primary outcome; the Phase 3 will randomize patients to 100 mg once-daily oral zervimesine or placebo for nine months.
The move builds on Phase 2 SHIMMER data showing an 89% slowdown in hallucination and delusion progression versus placebo, though endpoint alignment remains an unresolved regulatory step before the pivotal study can launch.