PURCHASE, N.Y. — September 29, 2026
Cognition Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) Division of Neurology has scheduled a Type C meeting for October 20, 2026, focused on the proposed primary endpoint for a planned Phase 3 registrational study of zervimesine (CT1812) in people with dementia with Lewy bodies (DLB) who experience psychosis symptoms. The meeting is expected to address the analytical and statistical details of the proposed endpoint and follows previous FDA interactions in which the agency aligned with Cognition on key elements of a pivotal trial design, including the use of psychosis as a primary outcome. Cognition currently expects the planned Phase 3 study to enroll patients experiencing hallucinations and delusions, with participants randomized to once-daily 100 mg zervimesine or placebo for nine months following screening.
FDA Meeting to Define Phase 3 Primary Endpoint
The October Type C meeting is intended to further align Cognition and FDA on an approvable primary endpoint for the planned Phase 3 DLB study. Meeting minutes received by the company in June 2026 provided alignment on several elements of the proposed pivotal design, including measurement of psychosis as a primary outcome. Cognition expects the trial population to include people with DLB who have hallucinations or delusions, regardless of whether they are receiving stable background medication or are untreated. The company has not yet finalized all analytical and statistical details of the primary endpoint and expects the FDA discussion to help define the endpoint for the registrational program. The planned nine-month randomized study is intended to compare oral zervimesine with placebo, with the final design remaining subject to regulatory alignment.
Zervimesine Advances After Phase 2 DLB Data
Zervimesine is an investigational once-daily oral therapy that Cognition is advancing based in part on results from the Phase 2 SHIMMER study in DLB. The company has reported that zervimesine slowed progression of hallucinations and delusions by 89% compared with placebo, as measured using the Neuropsychiatric Inventory (NPI). Cognition said zervimesine has generally been well tolerated in clinical studies conducted to date. The candidate is also being evaluated in the Phase 2 START study in patients with mild cognitive impairment and early Alzheimer’s disease, while Phase 2 studies in DLB, mild-to-moderate Alzheimer’s disease and geographic atrophy secondary to dry age-related macular degeneration have concluded. The company is using the DLB clinical findings to support development of a potential registrational program, although the Phase 2 results will require confirmation in a larger pivotal study.
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Phase 3 Program Targets DLB-Associated Psychosis
The proposed Phase 3 program is designed to evaluate zervimesine in people with DLB who experience psychosis, including hallucinations and delusions. DLB is a progressive neurodegenerative disease associated with cognitive, neuropsychiatric and motor symptoms, and psychosis is a frequent clinical feature of the condition. Cognition said there are currently no approved therapies specifically intended to slow DLB progression or treat its associated symptoms. Traditional antipsychotics may be used off-label in some settings but can present safety concerns in people with DLB, according to the company. Zervimesine is being developed as a potential disease-modifying therapy based on Cognition’s research into mechanisms involving toxic oligomers and neurodegenerative disease progression. The candidate remains investigational, and its safety and efficacy have not been established for regulatory approval in DLB.
Source :Cognition Therapeutics press release
