Developer · CGTX · United States

Cognition Therapeutics, Inc.

Clinical-stage biopharmaceutical company (Nasdaq: CGTX) developing small-molecule modulators of the sigma-2 receptor complex for age-related degenerative diseases of the CNS and retina. Incorporated in Delaware in 2007; principal executive offices in Purchase, New York, with laboratory operations in Pittsburgh, Pennsylvania. Its lead and only clinical candidate is zervimesine (CT1812), in Phase 2/registrational-stage development for Alzheimer's disease and dementia with Lewy bodies; clinical development has been funded by ~$171 million in cumulative grants, primarily from the National Institute on Aging.

cogrx.com ↗

1compound
2programs
2indications
Phase 2lead asset

Phase distribution

  • Phase 22

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Catalysts · 1 upcoming · 4 reported

  • Mid-2027 (registry estimate May 2027)Anticipated

    ZervimesineforAlzheimer's diseaseTopline data

    Topline results from the ~540-patient Phase 2 START study of zervimesine in MCI/early Alzheimer's disease (18-month treatment; CDR-SB and ADAS-Cog endpoints), expected after all participants complete 18 months of treatment — around mid-2027 per the ClinicalTrials.gov estimated primary completion of May 2027.

    NCT05531656source ↗

Recently reported

  • 2025-07-29met

    ZervimesineforLewy body dementiaFull results

    Full SHIMMER results presented in an AAIC 2025 podium presentation (with additional analyses spanning DLB and AD) and published in Alzheimer's & Dementia (Galvin et al. 2025): consistent benefit of zervimesine over placebo across neuropsychiatric, cognitive, motor and functional domains in mild-to-moderate DLB.

    source ↗

  • 2024-12-18met

    ZervimesineforLewy body dementiaTopline data

    Phase 2 SHIMMER topline (130 mild-to-moderate DLB patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoint met, with exploratory efficacy signals across behavioral (NPI-12 -82% vs placebo decline), cognitive-fluctuation (CAF -91%), motor (UPDRS-III -62%) and functional (ADCS-ADL -52%) measures.

    source ↗

  • 2024-10-31met

    ZervimesineforAlzheimer's diseaseFull results

    Pre-specified analysis of SHINE presented at CTAD (October 2024): mild-to-moderate AD participants with baseline plasma p-tau217 below the 1.0 pg/mL median treated with zervimesine (pooled 100/300 mg) showed a 95% reduction of cognitive decline at week 26 on ADAS-Cog 11 vs placebo, regardless of MMSE stratum — the analysis that defined the p-tau217 enrichment strategy FDA later endorsed for Phase 3.

    source ↗

  • 2024-07-29mixed

    ZervimesineforAlzheimer's diseaseTopline data

    Phase 2 SHINE topline (153 mild-to-moderate AD patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoints met; cognitive signal favoring zervimesine, with the strongest effect emerging in patients with lower baseline plasma p-tau217.

    source ↗

Recent activity

  • Jun 24, 2026Phase changeZervimesine·Lewy body dementiaPhase 2Program active and pointed at a registrational path in DLB PSYCHOSIS: following a January 2026 Type C meeting, the 2026-03-02 decision to develop zervimesine for DLB psychosis, and a 2026-05-20 meeting with the FDA Division of Psychiatry, Cognition announced on 2026-06-24 (on receipt of meeting minutes) alignment with FDA on key aspects of a pivotal study — nine-month randomized Phase 3, 100 mg once daily vs placebo, in DLB patients with hallucinations and delusions (stable off-label antipsychotics allowed), NPI as a novel primary endpoint — and FDA agreement that DLB psychosis could be an approvable indication. Registrational program expected to begin mid-2027. Phase not advanced: no pivotal trial is registered or started. (No event logged: the closed vocabulary has no code for a regulatory meeting/alignment.)source ↗
  • Nov 13, 2025Phase changeZervimesine·Alzheimer's diseasePhase 2Enrollment completed in the ~540-patient Phase 2 START study (COG0203, NCT05531656) in MCI/early AD per the company's 2025-11-13 announcement (the FY2025 10-K states the last participant was enrolled in December 2025 — the PR date is used here and the discrepancy noted). FDA alignment on a Phase 3 AD registrational path was already in hand (end-of-Phase 2 minutes received 2025-08-12), but no Phase 3 study has been registered or started, so the phase does not advance.source ↗
  • Jul 29, 2025ReadoutZervimesine·Lewy body dementiametFull SHIMMER results presented in an AAIC 2025 podium presentation (with additional analyses spanning DLB and AD) and published in Alzheimer's & Dementia (Galvin et al. 2025): consistent benefit of zervimesine over placebo across neuropsychiatric, cognitive, motor and functional domains in mild-to-moderate DLB.source ↗
  • Dec 18, 2024ReadoutZervimesine·Lewy body dementiametPhase 2 SHIMMER topline (130 mild-to-moderate DLB patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoint met, with exploratory efficacy signals across behavioral (NPI-12 -82% vs placebo decline), cognitive-fluctuation (CAF -91%), motor (UPDRS-III -62%) and functional (ADCS-ADL -52%) measures.source ↗
  • Nov 25, 2024Phase changeZervimesine·Lewy body dementiaPhase 2SHIMMER completed per ClinicalTrials.gov (primary completion and study completion 2024-11-25); the company announced all participants had completed final visits on 2024-11-26, with topline following on 2024-12-18.source ↗
  • Oct 31, 2024ReadoutZervimesine·Alzheimer's diseasemetPre-specified analysis of SHINE presented at CTAD (October 2024): mild-to-moderate AD participants with baseline plasma p-tau217 below the 1.0 pg/mL median treated with zervimesine (pooled 100/300 mg) showed a 95% reduction of cognitive decline at week 26 on ADAS-Cog 11 vs placebo, regardless of MMSE stratum — the analysis that defined the p-tau217 enrichment strategy FDA later endorsed for Phase 3.source ↗
  • Jul 29, 2024ReadoutZervimesine·Alzheimer's diseasemixedPhase 2 SHINE topline (153 mild-to-moderate AD patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoints met; cognitive signal favoring zervimesine, with the strongest effect emerging in patients with lower baseline plasma p-tau217.source ↗
  • May 19, 2022Phase changeZervimesine·Lewy body dementiaPhase 2Phase 2 SHIMMER study (COG1201, NCT05225415) started per ClinicalTrials.gov: randomized, double-blind, placebo-controlled study of zervimesine 100 mg or 300 mg vs placebo once daily for six months in 130 adults with mild-to-moderate dementia with Lewy bodies. Funded primarily by an NIA grant (~$29.5M, awarded 2021).source ↗
  • Oct 10, 2018Phase changeZervimesine·Alzheimer's diseasePhase 2Phase 2 SHINE study (COG0201, NCT03507790) started: randomized, double-blind, placebo-controlled, 153 adults with mild-to-moderate AD, zervimesine 100 mg or 300 mg vs placebo once daily for six months. NIA-funded ($16.8M initial + $13.6M 2021 amendment).source ↗
  • Sep 1, 2016Phase changeZervimesine·Alzheimer's diseasePhase 1/2First-in-patient study in mild-to-moderate Alzheimer's disease (COG0102, NCT02907567, n=19) started September 2016 (registry month precision; day is a placeholder).source ↗
  • Sep 1, 2015Phase changeZervimesine·Alzheimer's diseasePhase 1First-in-human ascending-dose study of CT1812 in healthy volunteers (COG0101, NCT02570997) started September 2015 (registry month precision; day is a placeholder). Conducted in Australia; NIA-funded.source ↗

Competitive landscape

Other companies developing against Cognition Therapeutics, Inc.'s targets or indications.