Cognition Therapeutics aligns Phase 3 DLB trial design with FDA

Cognition Therapeutics, Inc. (NASDAQ: CGTX) has reached alignment with the U.S. Food and Drug Administration on the core design elements of a pivotal Phase 3 clinical trial for zervimesine (CT1812) in dementia with Lewy bodies (DLB). The agreement, announced October 22, 2026, covers patient selection, dosing, study duration, and primary endpoints for the planned registrational study.

The trial is expected to enroll participants with mild-to-moderate DLB, who will be randomized to receive either a 100 mg once-daily oral dose of zervimesine or a placebo over a nine-month period. Lisa Ricciardi, president and CEO of Cognition Therapeutics, stated that the company engaged in collaborative discussions with the FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience throughout the year to finalize this protocol. Ricciardi noted that DLB currently has no approved treatments, making the completion of this protocol a significant step toward addressing the disease.

A primary endpoint for the Phase 3 study will be the Neuropsychiatric Inventory (NPI-2), a measure of hallucinations and delusions. Anthony O. Caggiano, MD, PhD, Cognition’s chief medical officer, explained that hallucinations are a core diagnostic feature of DLB that often occur early in the disease and worsen as it progresses. Caggiano stated that because there are no blood-based biomarkers to measure DLB progression, clinicians rely on these key features to determine how rapidly the disease is advancing. He added that changes in psychosis may serve as a proxy for changes in the underlying disease.

The study will also include the Alzheimer's Disease Cooperative Study: Activities of Daily Living (ADCS-ADL) scale as a key secondary endpoint to evaluate zervimesine’s impact on daily function. Zervimesine is an investigational once-daily oral therapy that has previously demonstrated promise in Phase 2 clinical trials in DLB and mild-to-moderate Alzheimer’s disease. In the Phase 2 SHIMMER study in DLB (NCT05225415), the drug was shown to slow disease progression, resulting in a slowing of neuropsychiatric, cognitive, motor, and functional symptom progression. The company reported that zervimesine has been generally well tolerated in clinical studies to date.

Cognition Therapeutics is a clinical-stage biopharmaceutical company developing therapies for neurodegenerative disorders. The company’s research is backed by nearly $200 million in grants from the National Institutes of Health and related foundations. DLB is a progressive neurodegenerative disease estimated to affect 1.4 million Americans, though more than half of those living with the condition are never diagnosed during their lifetime. Zervimesine is protected by an intellectual property portfolio that includes a recently issued composition of matter patent covering a novel crystalline form with a natural expiration date of 2045.