Cognition Therapeutics Secures FDA Alignment on Pivotal Zervimesine Trial Design for DLB Psychosis

With no approved pharmacotherapy for psychosis in dementia with Lewy bodies, Cognition Therapeutics has cleared a critical regulatory checkpoint: written FDA alignment on the core design elements of a pivotal trial for zervimesine (CT1812), positioning the company to file an NDA if Phase 3 succeeds. The registrational program is expected to initiate in mid-2027.

The FDA confirmed that DLB psychosis constitutes an approvable outcome and agreed on key trial parameters. The proposed Phase 3 study will enroll patients with DLB experiencing hallucinations and delusions, including those on stable background off-label antipsychotic therapy. Participants will be randomized to 100 mg once-daily oral zervimesine or placebo over a nine-month treatment period.

For regulatory affairs leads, the more consequential detail is the endpoint strategy. Cognition will work with the FDA to finalize the analytical and statistical framework for the Neuropsychiatric Inventory (NPI) as a novel primary endpoint in a DLB psychosis pivotal trial. NPI has not previously served in this registrational role, and the agency's willingness to engage on its validation signals a precedent with implications beyond this single program.

The Phase 3 design draws directly from the Phase 2 COG1201 SHIMMER trial in mild-to-moderate DLB, where zervimesine demonstrated an 89% reduction in hallucination and delusion progression versus placebo as measured by the NPI. Additional analyses from SHIMMER are scheduled for presentation at the Alzheimer's Association International Conference (AAIC) in July 2026, providing further data to support the endpoint rationale ahead of IND-enabling work for the registrational study.

No drug has received approval for DLB psychosis; current clinical practice relies on off-label antipsychotics carrying their own safety liabilities. If the NPI framework is accepted as a validated primary endpoint through this program, it could establish a measurable efficacy standard that shapes future NDA submissions across rare neurological indications where validated instruments remain absent.

The analytical and statistical agreement with FDA on NPI methodology will be the next concrete milestone to watch as Cognition moves toward the mid-2027 program start.

Source: Cognition Therapeutics, Inc. via GlobeNewswire, June 24, 2026.