CGTX News & Events

Cognition Therapeutics announced plans to advance development of zervimesine for the treatment of dementia with Lewy bodies psychosis, which impacts as many as 75% of patients. This follows receipt of final minutes from the U.S. Food and Drug Administration, FDA, pertaining to the Type C meeting that was conducted on January 21, 2026.

Cognition Therapeutics conducted a Type C meeting with the U.S. Food and Drug Administration on January 21, 2026. The objective of this meeting was to review plans for the proposed Phase 2b study of zervimesine in dementia with Lewy bodies, a disease with no FDA-approved therapies. "We had a productive meeting with the FDA, during which we discussed clinically meaningful endpoints for the next Phase 2b study of mild-to-moderate DLB," stated Anthony O. Caggiano, MD, PhD, Cognition's chief medical officer. "We look forward to receiving meeting minutes later this quarter and continuing our dialogue with the FDA to advance clinical development in DLB."

Cognition Therapeutics announced that a manuscript entitled, "Phase 2 Study of Zervimesine in Participants with Mild-to-Moderate Dementia with Lewy Bodies" has been published in the journal, Alzheimer's & Dementia, the journal of the Alzheimer's Association. Results from this study were first presented in January 2025 at the International Lewy Body Dementia Conference in Amsterdam. "The Phase 2 SHIMMER study, our first in DLB, met its primary goal of confirming zervimesine's safety and tolerability," explained Anthony Caggiano, Cognition's chief medical officer. "Importantly, zervimesine was also shown to have a favorable impact on behavioral, cognitive, functional, and movement domains, many of which are core clinical features of DLB. There are currently no approved disease-modifying treatments for DLB, highlighting the unmet need for novel therapies."