Please use a PC Browser to access Register-Tadawul
Cognition Therapeutics Announces Phase 3 Trials of Zervimesine for Mild-to-Moderate Alzheimer's Disease
Cognition Therapeutics, Inc. CGTX | 1.35 | -1.46% |
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.


