Cognition Therapeutics Schedules a Type C Meeting with FDA to Align on Endpoints for Phase 3 Trial of Zervimesine (CT1812) in DLB
Key Highlights
- ➤FDA Type C meeting set for October 20, 2026, on DLB Phase 3 endpoint alignment
- ➤Psychosis accepted by FDA as potentially approvable outcome and DLB progression marker
- ➤Phase 3 plans 100 mg once-daily zervimesine versus placebo for nine months
- ➤Phase 2 zervimesine slowed hallucination and delusion progression 89% versus placebo
Expert Statements
Anthony O. Caggiano, Chief Medical Officer of Cognition Therapeutics
“Hallucinations are a core feature of DLB and often occur early in the disease, sometimes before cognitive changes are observed.”
Anthony O. Caggiano, Chief Medical Officer of Cognition Therapeutics
“Importantly, researchers have found that psychosis symptoms, such as hallucinations and delusions, typically worsen as DLB progresses.”
Anthony O. Caggiano, Chief Medical Officer of Cognition Therapeutics
“In previous meetings, FDA agreed that psychosis could be an approvable outcome and could represent a marker for DLB disease progression.”
Anthony O. Caggiano, Chief Medical Officer of Cognition Therapeutics
“We look forward to discussing this in more detail with our Agency colleagues in October and aligning on an approvable endpoint to deploy in our planned Phase 3 study.”
Lisa Ricciardi, President and CEO of Cognition Therapeutics
“We look forward to meeting with the agency to finalize details of our registrational trial of zervimesine in DLB.”
Lisa Ricciardi, President and CEO of Cognition Therapeutics
“Our ultimate goal is to provide patients and their families with a disease-modifying treatment option that slows the progression of DLB, and by so doing, delays the onset or worsening of symptoms.”
PURCHASE, N.Y., Sept. 29, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), announced that a Type C meeting with the U.S. Food and Drug Administration (FDA) Division of Neurology has been scheduled 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 registrational study of zervimesine (CT1812) in people with dementia with Lewy bodies (DLB) who experience psychosis symptoms.
"Hallucinations are a core feature of DLB and often occur early in the disease, sometimes before cognitive changes are observed," explained Anthony O. Caggiano, MD, PhD, CMO of Cognition. "Importantly, researchers have found that psychosis symptoms, such as hallucinations and delusions, typically worsen as DLB progresses. In previous meetings, FDA agreed that psychosis could be an approvable outcome and could represent a marker for DLB disease progression. We look forward to discussing this in more detail with our Agency colleagues in October and aligning on an approvable endpoint to deploy in our planned Phase 3 study."
Get started
Create a free account to read the full story.