Cognition Therapeutics presents Phase 3 plan for zervimesine in Alzheimer’s

Cognition Therapeutics (CGTX) presented plans for a registrational program for zervimesine in mild-to-moderate Alzheimer’s disease during the annual Clinical Trials on Alzheimer’s Disease conference. Cognition discussed the program design with the U.S. Food and Drug Administration during an end-of-Phase 2 meeting. The CTAD poster will be available on the Publications page of the company website in accordance with the conference embargo policy. The Phase 3 program is expected to enroll adults with mild-to-moderate Alzheimer’s disease who have lower levels of plasma p-tau217 at screening. Based on Phase 2 clinical study results, the Company believes that screening for p-tau217 levels will enrich the study population with patients most likely to benefit from zervimesine treatment. The U.S. Food and Drug Administration agreed with this approach during the July 2025 end-of-Phase 2 meeting. FDA meeting minutes stated that two six-month Phase 3 studies with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily may be sufficient. Efficacy may be measured using the iADRS, a composite of the ADAS-Cog 13 and ADCS-ADL, validated scales measuring cognition and function. Participants who complete either study will be eligible to enroll in an open-label extension.