Cognition Therapeutics Aligns With FDA On Key Elements Of Phase 3 Study In Dementia With Lewy Bodies Including Patient Selection, Dose, Duration, And Endpoints

The planned registrational study is expected to enroll participants with mild-to-moderate DLB who will be randomized to receive either 100 mg of once-daily oral zervimesine or placebo for nine months.

"Over the course of the year, we have had collaborative discussions with FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience," stated Lisa Ricciardi, president and CEO of Cognition. "With FDA’s alignment on trial design, we are completing a protocol to support the planned registrational study in DLB, a disease with no approved treatments."

Among DLB’s core diagnostic features, hallucinations are one of the most measurable symptoms. Cognition’s Phase 3 study will use a neuropsychiatric inventory that measures hallucinations and delusions (NPI‑2) as a primary endpoint. A key secondary endpoint will be the Alzheimer's Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) scale, which will evaluate zervimesine’s treatment impact on daily function.

"There are currently no blood-based biomarkers to measure how DLB is progressing, so clinicians evaluate key features to determine how rapidly DLB is progressing," explained Anthony O. Caggiano, MD, PhD, Cognition’s CMO. "One such feature is the presence of hallucinations. Hallucinations occur in a majority of people with DLB, often occur early in disease, and typically worsen as the disease progresses. We believe their presence in early stages and predictable decline means that changes in psychosis may serve as a proxy for changes in underlying disease."