Cognition Therapeutics gains FDA alignment for phase 3 DLB psychosis trial

• Cognition Therapeutics (NASDAQ:CGTX) received FDA alignment on key elements of a pivotal Phase 3 trial of zervimesine (CT1812) for psychosis in dementia with Lewy bodies.
• The registrational program is expected to begin in mid-2027 with the neuropsychiatric inventory as a proposed primary endpoint.
• Cognition Therapeutics (NASDAQ:CGTX) plans to evaluate zervimesine in patients experiencing hallucinations and delusions.

Cognition Therapeutics (NASDAQ:CGTX) reported FDA alignment on key elements of a pivotal Phase 3 trial of zervimesine (CT1812) for the treatment of psychosis in dementia with Lewy bodies (DLB).

The FDA agreed that DLB psychosis could be an approvable outcome, supporting a potential registrational pathway.

The planned study will randomize DLB patients with hallucinations and delusions to 100 mg once-daily oral zervimesine or placebo for nine months while allowing stable off-label antipsychotics.

Cognition Therapeutics is working with the FDA to use the neuropsychiatric inventory (NPI) as a novel primary endpoint.

The company cited Phase 2 data in which zervimesine slowed progression of hallucinations and delusions by 89%.

Cognition Therapeutics is developing zervimesine as a potential new treatment option for neuropsychiatric symptoms in dementia with Lewy bodies.

The company continues to advance its pipeline targeting cognitive and psychiatric symptoms in neurodegenerative diseases.