Cognition Therapeutics Schedules Meeting with FDA for Phase 3 Trial of Zervimesine

PURCHASE, N.Y., Sept. 29, 2026 /CourierPR/ -- Cognition Therapeutics, a clinical-stage company developing therapies for neurodegenerative disorders, has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for October 20, 2026. The objective of this meeting is to align with the FDA on the analytical and statistical details pertaining to the proposed primary endpoint for the planned Phase 3 trial of zervimesine (CT1812) in people with dementia with Lewy bodies (DLB) who experience psychosis symptoms.

Anthony O. Caggiano, MD, PhD, Chief Medical Officer of Cognition, explained that hallucinations are a core feature of DLB and often occur early in the disease, sometimes before cognitive changes are observed.

Cognition currently expects the Phase 3 study will enroll people with DLB who experience psychosis symptoms of hallucinations and delusions. Participants are expected to be eligible whether they are on stable background medication or are untreated. Following screening, participants will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months.

Dementia with Lewy bodies (DLB) is a progressive, fatal neurodegenerative disease characterized by neuropsychiatric, cognitive, and motor deficits. There are no approved drugs to slow the decline of DLB or treat the symptoms associated with the disease. Up to 80% of people living with DLB experience psychosis, which manifests as debilitating hallucinations and delusions. Hallucinations are a core feature and are among the diagnostic criteria for DLB. Psychosis symptoms are frequently cited as the most challenging for patients and their care partners to manage. The off-label use of traditional antipsychotics is often avoided due to the risk of severe and potentially life-threatening adverse reactions, underscoring a critical unmet need.

In a Phase 2 trial, zervimesine slowed progression of hallucinations and delusions by 89% compared to placebo, as measured by the neuropsychiatric inventory (NPI). In studies to date, zervimesine has been generally well tolerated. The company's lead candidate, 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. Zervimesine (CT1812) is currently being studied in the Phase 2 START Study (NCT05531656) in patients with mild cognitive impairment (MCI) and early Alzheimer’s disease. Phase 2 clinical studies have concluded in dementia with Lewy bodies (DLB), mild-to-moderate Alzheimer’s disease, and geographic atrophy secondary to dry age-related macular degeneration (AMD).

Based in part on the strong efficacy signals observed in the Phase 2 SHIMMER study in DLB (NCT05225415), the company plans to advance zervimesine into a registrational trial for people with DLB who experience psychosis. Zervimesine has been generally well tolerated in clinical studies to date.

Cognition Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to helping millions of families seeking effective treatments for devastating neurodegenerative diseases through the development of novel, accessible therapies. The company has led pioneering research into the underlying mechanisms of degenerative nerve disorders. Our scientific approach builds on well-established biological pathways and translates across indications in which toxic oligomers drive disease progression, offering potential in dementia with Lewy bodies (DLB), Alzheimer’s disease, geographic atrophy, Parkinson’s, among others. Backed by nearly $200 million in National Institutes of Health and related foundation grants, Cognition Therapeutics continues to advance clinical research in its efforts to bring forth solutions that meet patients where they are and reduce caregiver burden.