Summarized by Masters of Longevity from Longevity Technology.
A news article previewing talks between a drug developer and regulators about choosing trial endpoints for a Lewy body dementia psychosis therapy; it explains why the meeting matters for future study design and approval prospects.
Key Takeaways
- Cognition Therapeutics scheduled a Type C meeting with the FDA on October 20 to align the Phase 3 primary endpoint for zervimesine.
- Company-reported Phase 2 SHIMMER results claimed an 89% slowing of hallucinations and delusions versus placebo on the NPI scale.
- Up to 80% of people with dementia with Lewy bodies experience psychosis and no approved therapies currently slow DLB progression.
