Cognition Therapeutics Completes FDA Type B Meeting for Zervimesine Registrational Program in DLB Psychosis

A registrational path for zervimesine (CT1812) in dementia with Lewy bodies psychosis moved a step closer on May 20, 2026, when Cognition Therapeutics completed a planned meeting with the FDA to review Phase 2 data and align on late-stage trial design. For regulatory affairs leads tracking rare neurodegenerative indications, the outcome signals that the agency has engaged substantively with the COG1201 SHIMMER study results and the proposed registrational framework.

The meeting centered on data from the Phase 2 SHIMMER study (NCT05225415) in DLB patients with psychosis and Cognition's proposed endpoints and design for a pivotal trial. President and CEO Lisa Ricciardi confirmed the discussion was productive and that the company anticipates receiving FDA formal minutes in June 2026, which will define the parameters the agency expects the registrational program to meet.

Zervimesine is an investigational once-daily oral sigma-2 receptor modulator. Phase 2 studies have concluded across DLB, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD. A separate Phase 2 START study (NCT05531656) in mild cognitive impairment and early Alzheimer's disease remains ongoing. The compound has been generally well tolerated across completed studies, and the USAN Council has formally adopted zervimesine as the United States Adopted Name for CT1812.

The clinical development program has been supported by nearly $200 million in NIH and related foundation grants, a funding structure that reduces the capital exposure typical of clinical-stage sponsors advancing into registrational work. For regulatory teams benchmarking Type B meeting strategy, the Cognition approach illustrates how Phase 2 efficacy signals in an unmet-need indication can anchor a pre-Phase 3 alignment discussion on endpoints and study design before IND amendments are filed.

Receipt of the FDA's formal meeting minutes in June will determine whether Cognition can proceed directly to registrational study initiation or whether additional agency feedback requires protocol revision before the late-stage program is locked.

Source: Cognition Therapeutics, Inc. via GlobeNewswire, May 21, 2026.