Cognition Therapeutics has scheduled a Type C meeting with the U.S. Food and Drug Administration Division of Neurology on October 20, 2026, to align on analytical and statistical details for the proposed primary endpoint of a planned registrational Phase 3 study of Zervimesine in people with dementia with Lewy bodies who experience psychosis.
Previous meeting minutes from June 2026 provided alignment on key trial design elements, including measuring psychosis as a primary outcome.
The planned Phase 3 is expected to enroll people with hallucinations and delusions who may be on stable background medication or untreated; following screening, participants will be randomized to receive either 100 mg of once-daily oral Zervimesine or placebo for nine months.
In a Phase 2 trial, the company claims Zervimesine slowed progression of hallucinations and delusions by 89% versus placebo as measured by the neuropsychiatric inventory, and the company states the drug has been generally well tolerated in studies to date.
Zervimesine is also being studied in a Phase 2 trial in mild cognitive impairment and early Alzheimer’s disease, and has been adopted as the USAN for CT1812.
