Cognition Therapeutics Aligns With FDA on Phase 3 Dementia With Lewy Bodies Trial; CGTX Rises Pre-Market

Cognition Therapeutics (CGTX) said it has aligned with the U.S. FDA on key aspects of a planned Phase 3 study of zervimesine (CT1812) in dementia with Lewy bodies, clearing the way for a potential registrational trial. The stock rose 7.02% to $0.77 in pre-market trading after closing Wednesday at $0.74, up 1.74%. The trial will randomly assign patients with mild-to-moderate DLB to 100 mg once-daily oral zervimesine or placebo for nine months. The FDA and company agreed on patient selection, dosage, duration and endpoints. The primary endpoint measures changes in hallucinations and delusions using the NPI-2 assessment; a key secondary endpoint evaluates daily activities via the ADCS-ADL scale. The program builds on the Phase 2 SHIMMER study, in which the company said zervimesine slowed progression of neuropsychiatric, cognitive, motor and functional symptoms. Zervimesine is also in the Phase 2 START study for mild cognitive impairment and early Alzheimer's disease. CGTX has traded between $0.55 and $1.83 over the past year.