Cognition Therapeutics will meet the FDA on 20 October to finalize how success is measured in a planned Phase 3 trial of zervimesine (CT1812) for dementia with Lewy bodies, with psychosis — hallucinations and delusions — proposed as the primary endpoint. The agency has previously indicated psychosis could serve both as an approvable outcome and as a marker of disease progression. In the earlier Phase 2 SHIMMER study, the company reported an 89% slowing of progression in hallucinations and delusions versus placebo on the neuropsychiatric inventory.
Key Points
- FDA meeting to settle psychosis as primary Phase 3 endpoint
- Phase 2 reported 89% slower progression of hallucinations versus placebo
- No approved treatments exist for dementia with Lewy bodies
Longevity Analysis
Hallucinations preceding measurable cognitive decline illustrate how neurodegenerative processes announce themselves through signals that are easily mislabeled as psychiatric rather than structural. Zervimesine targets the sigma-2 receptor pathway implicated in handling toxic protein oligomers — a question of whether neurons can clear and recover from misfolded protein burden rather than merely compensate for it. The regulatory question at stake, whether a symptom can stand in for underlying disease progression, has consequences well beyond this one compound for how slowing neurological decline gets defined and approved.
Original published by Longevity.Technology, by Kyle Umipig.