Cognition Therapeutics, Inc. (NASDAQ: CGTX) announced on October 22, 2026, that it has received written feedback from the U.S. Food and Drug Administration (FDA) confirming alignment on key elements for a pivotal Phase 3 study in dementia with Lewy bodies (DLB). The company stated that the planned registrational study will enroll participants with mild-to-moderate DLB who will be randomized to receive either 100 mg of once-daily oral zervimesine or a placebo for a duration of nine months.
The FDA alignment covers critical aspects of the trial design, including patient selection, dose, duration, and endpoints. The study will utilize the Neuropsychiatric Inventory (NPI-2) as a primary endpoint to measure hallucinations and delusions, which the company notes are core diagnostic features of DLB. A key secondary endpoint will be the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) scale, which will evaluate the treatment's impact on daily function.
Lisa Ricciardi, President and CEO of Cognition Therapeutics, stated that the company has conducted collaborative discussions with the FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience over the past year. Anthony O. Caggiano, M.D., Ph.D., the company’s Chief Medical Officer, explained that hallucinations occur in a majority of people with DLB and typically worsen as the disease progresses, making changes in psychosis a potential proxy for underlying disease changes.
The company noted that there are currently no approved drugs to slow the decline of DLB or treat its core symptoms. Zervimesine (CT1812) is an investigational once-daily oral therapy that has demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer's disease. The company is backed by nearly $200 million in National Institutes of Health and related foundation grants.
