Cognition Therapeutics Announces Alignment with FDA on Pivotal Phase 3 Trial of Zervimesine (CT1812) in Dementia with Lewy Bodies
Key Highlights
- ➤FDA aligns on pivotal Phase 3 DLB trial design for Cognition’s zervimesine
- ➤Trial will enroll mild-to-moderate DLB patients for nine months
- ➤100 mg once-daily zervimesine will be compared with placebo
- ➤NPI-2 hallucinations and delusions score will serve as primary endpoint
- ➤ADCS-ADL daily-function scale will be the key secondary endpoint
Expert Statements
Lisa Ricciardi, President and CEO of Cognition Therapeutics
“Over the course of the year, we have had collaborative discussions with FDA’s Divisions of Neurology and Psychiatry within the Office of Neuroscience.”
Lisa Ricciardi, President and CEO of Cognition Therapeutics
“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.”
Anthony O. Caggiano, MD, PhD, Chief Medical Officer of Cognition Therapeutics
“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.”
Anthony O. Caggiano, MD, PhD, Chief Medical Officer of Cognition Therapeutics
“One such feature is the presence of hallucinations.”
Anthony O. Caggiano, MD, PhD, Chief Medical Officer of Cognition Therapeutics
“Hallucinations occur in a majority of people with DLB, often occur early in disease, and typically worsen as the disease progresses.”
Anthony O. Caggiano, MD, PhD, Chief Medical Officer of Cognition Therapeutics
“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.”
PURCHASE, N.Y., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, has aligned with the U.S. Food and Drug Administration (FDA) on key elements of a Phase 3 study in 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 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.”
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