Cognition Therapeutics Sets Oct. 20, 2026 FDA Type C Meeting on Phase 3 Zervimesine Trial for Lewy Body Dementia Psychosis

Cognition Therapeutics Inc. (CGTX) said it will hold a Type C meeting with the FDA Division of Neurology on October 20, 2026, to align on analytical and statistical details for a planned Phase 3 registrational study of Zervimesine in dementia with Lewy bodies (DLB) patients with psychotic symptoms. The company previously aligned with the FDA on key design aspects, using psychosis as a marker of disease progression. The trial will randomize DLB patients with psychosis to a 100 mg dose of Zervimesine (CT1812) or placebo. The investigational once-daily oral therapy targets neurodegenerative diseases including Alzheimer's and Lewy body dementia. Up to 80% of DLB patients may exhibit psychosis, marked by hallucinations and delusions that antipsychotics often fail to treat fully. CGTX traded at $0.94, down 0.06%.