FDA Aligns on Key Elements of Phase 3 Study of Zervimesine for Dementia With Lewy Bodies

The US Food and Drug Administration (FDA) and Cognition Therapeutics have aligned on key elements of a phase 3 study of zervimesine for the treatment of dementia with Lewy bodies (DLB), including patient selection, dose, duration, and endpoints. The planned registrational study is expected to enroll participants with mild-to-moderate DLB who will be randomly assigned to receive either 100 mg of once-daily oral zervimesine or placebo for 9 months.¹

Zervimesine is an investigational, small-molecule oral therapy, that prevents toxic oligomers from binding to neurons by way of the sigma-2 receptor. This oligomer-focused mechanism of action has great potential to protect synaptic integrity and function in patients with challenging neurodegenerative diseases.²

“Over the course of the year, we have had collaborative discussions with FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience,” said Lisa Ricciardi, the 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.”

Hallucinations are one of the most measurable symptoms of DLB’s core diagnostic features. Cognition’s phase 3 study will use a neuropsychiatric inventory that specifically 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; this will measure zervimesine’s 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,” said Anthony O. Caggiano, MD, PhD, the chief medical officer of Cognition. “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.”

More About Zervimesine

Zervimesine is currently being studied in the phase 2 START Study in patients with MCI and early Alzheimer disease. Previous phase 2 clinical studies evaluated servimesine in (DLB), mild-to-moderate Alzheimer disease, and geographic atrophy secondary to dry AMD. In the phase 2 SHIMMER study in DLB, zervimesine was shown to slow DLB disease progression, resulting in a slowing of neuropsychiatric, cognitive, motor, and functional symptom progression. Zervimesine has been generally well tolerated in clinical studies to date.

References

1. Cognition Therapeutics announces alignment with FDA on pivotal phase 3 trial of zervimesine (CT1812) in dementia with Lewy bodies. News release. October 22, 2026. Accessed October 23, 2026. https://www.globenewswire.com/news-release/2026/10/22/3386131/0/en/cognition-therapeutics-announces-alignment-with-fda-on-pivotal-phase-3-trial-of-zervimesine-ct1812-in-dementia-with-lewy-bodies.html

2. Pipeline. Cognition Therapeutics. Accessed October 23, 2026. https://cogrx.com/pipeline/