Cognition Therapeutics aligns with FDA on Phase 3 design for zervimesine in Lewy body dementia

Cognition Therapeutics announced on October 22, 2026 that it had reached alignment with the FDA on key elements of a Phase 3 study in dementia with Lewy bodies, including patient selection, dose, duration, and endpoints.¹ The announcement was also disclosed in an 8-K filing noting the company received written feedback from the FDA confirming alignment on key elements of the Phase 3 study.¹

Under the planned design, the study is expected to enroll patients with mild-to-moderate DLB, who would be randomized to take either 100 mg of oral zervimesine once daily or placebo over a nine-month period.¹

CEO Lisa Ricciardi said the company had spent the year in discussions with FDA's Divisions of Neurology and Psychiatry within the Office of Neuroscience, and with trial design now aligned, Cognition is finalizing a protocol for the registrational study in a disease that currently has no approved treatments.¹

For endpoints, the trial's primary measure will be the "NPI-2," an instrument tracking hallucinations and delusions, two of the disease's more quantifiable features, according to the release. A secondary measure will assess activities of daily living using the ADCS-ADL scale. CMO Anthony Caggiano explained the rationale, noting that there are no blood-based biomarkers for DLB progression, so clinicians rely on features like hallucinations, which affect most DLB patients, often appear early, and tend to worsen over time, making changes in psychosis a potential proxy for underlying disease changes.¹

The company pointed to earlier data from its Phase 2 "SHIMMER" study (NCT05225415) in DLB, which the release said showed zervimesine slowing progression across neuropsychiatric, cognitive, motor, and functional measures. Separately, zervimesine remains in its Phase 2 "START" study (NCT05531656) in MCI and early Alzheimer's disease, and Phase 2 studies have also concluded in DLB, mild-to-moderate Alzheimer's disease, and geographic atrophy secondary to dry AMD.¹