---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-077060"
form_type: "8-K"
ticker: "CGTX"
cik: "0001455365"
company_name: "COGNITION THERAPEUTICS INC"
filed_at: "2026-06-24T11:39:06+00:00"
generated_at: "2026-06-24T11:40:10.555234+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Cognition Therapeutics receives FDA alignment on pivotal trial design for zervimesine in DLB psychosis

## Summary
- FDA agreed that DLB psychosis is an approvable outcome; key aspects of Phase 3 trial design aligned.
- Phase 3 study expected to start mid-2027; enrollment of DLB patients with psychosis, randomized to 100 mg zervimesine or placebo for 9 months.
- Company to use NPI as novel primary endpoint; FDA will collaborate on analytical and statistical details.
- Phase 2 SHIMMER trial showed zervimesine slowed progression of hallucinations and delusions by 89% vs placebo.
- No approved treatments for DLB psychosis; current off-label antipsychotics are considered potentially dangerous.

## SEC filing metadata
- accession: 0001104659-26-077060
- form_type: 8-K
- ticker: CGTX
- cik: 0001455365
- company_name: COGNITION THERAPEUTICS INC
- filed_at: 2026-06-24T11:39:06+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/0001104659-26-077060-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1455365/000110465926077060/tm2618699d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-077060
- JSON: https://secwatch.observer/filing/0001104659-26-077060.json
- Plain text: https://secwatch.observer/filing/0001104659-26-077060.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.