Cognition Therapeutics Inc. has announced plans for a Phase 3 registrational program evaluating zervimesine (CT1812) in adults with mild-to-moderate Alzheimer's disease. The study will enroll participants with lower plasma p-tau217 levels, a strategy supported by the U.S. Food and Drug Administration (FDA) following an end-of-Phase 2 meeting in July 2025. The Phase 3 program will consist of two six-month studies, with participants randomized to receive either 100 mg of oral zervimesine or placebo daily. Efficacy will be measured using the iADRS scale. Results from the Phase 2 "SHINE" study, previously presented, indicated that zervimesine slowed cognitive decline in patients with lower p-tau217 levels. Details of the Phase 3 trial design were presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference held December 1-4, 2025. Cognition Therapeutics is also seeking alignment with the European Medicines Agency $(EMA)$ regarding their global registrational plans.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cognition Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9593837-en) on December 01, 2025, and is solely responsible for the information contained therein.
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