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FDA agreed DLB psychosis is an approvable indication and aligned on key aspects of a Phase 3 registrational trial design. The study will randomize DLB patients with hallucinations/delusions to 100 mg zervimesine or placebo for nine months, using NPI as the primary endpoint. Trial start is expected mid-2027.
EX-99.1 2 tm2618699d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes - Zervimesine Would be the First Long-term, Durable Treatment Option with an Impact on Underlying Disease - - Company Developing NPI as a Measure of DLB Psychosis - PURCHASE, NY – June 24, 2026 – Cognition Therapeutics, Inc. , (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an app