Zervimesine (CT1812) - (SHIMMER)

Sept. 29, 2026: Cognition Therapeutics (NASDAQ: CGTX) said the FDA Division of Neurology has scheduled a Type C meeting for Oct. 20, 2026 to discuss analytical and statistical details for the proposed primary endpoint in a planned registrational/Phase 3 study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) patients with psychosis.

The company said prior FDA meeting minutes received in June 2026 aligned on key aspects of the pivotal trial design, including use of psychosis as the primary outcome. The planned Phase 3 is expected to enroll DLB patients with hallucinations and delusions, whether untreated or on stable background medication, and randomize them to once-daily oral zervimesine 100 mg or placebo for nine months.

As supporting data, Cognition said Phase 2 SHIMMER results in DLB showed zervimesine slowed progression of hallucinations and delusions by 89% versus placebo on the Neuropsychiatric Inventory, and that the drug has been generally well tolerated to date. The company said it plans to advance zervimesine into the registrational DLB psychosis trial. Separately, zervimesine is being studied in the Phase 2 START study (NCT05531656) in MCI and early Alzheimer’s disease.