Zervimesine (CT1812) - (SHIMMER)

June 24, 2026: Cognition Therapeutics, Inc. (NASDAQ: CGTX) said it received written FDA feedback after a recent meeting regarding zervimesine (CT1812) for psychosis associated with dementia with Lewy bodies (DLB). FDA agreed that DLB psychosis (hallucinations and delusions) could be an approvable outcome and aligned with the company on key aspects of a pivotal, registrational Phase 3 trial intended to support an NDA; the program is expected to begin in mid-2027.

Proposed Phase 3 design: enroll DLB patients with psychosis symptoms; allow stable background off-label antipsychotics; randomize to 100 mg once-daily oral zervimesine vs placebo for nine months. Cognition plans to work with FDA on analytical/statistical details to use the Neuropsychiatric Inventory (NPI) as a novel primary endpoint.

Supporting data: the Phase 2 COG1201 “SHIMMER” trial in mild-to-moderate DLB showed improvements in psychosis symptoms vs placebo by NPI; a recent analysis reported zervimesine slowed progression of hallucinations and delusions by 89%. Upcoming: additional Phase 2 analyses on NPI hallucination/delusion components to be presented in July at the Alzheimer’s Association International Conference (AAIC).