deltatrials
Recruiting INTERVENTIONAL NCT06937229

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Sponsor: Bristol-Myers Squibb

Interventions KarX-EC KarXT
Updated 10 times since 2025 Last updated: Apr 20, 2026 Started: Dec 2, 2025 Primary completion: Jun 22, 2029 Completion: Jul 20, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06937229, this observational or N/A phase trial focuses on Agitation and Alzheimer Disease and remains actively recruiting participants. Sponsored by Bristol-Myers Squibb, it has been updated 10 times since 2025, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Nov 2025 · 31 days · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Feb 2026 · 2 months · monthly snapshotNot Yet Recruiting~Feb 2026 – ~Apr 2026 · 3 months · monthly snapshotRecruitingApr 21, 2026 – present · 56 days · daily APIRecruiting

Change History

10 versions recorded
  1. Apr 21, 2026 — Present [daily]

    Recruiting

    Phase: PHASE3None

  2. Feb 2026 — Apr 2026 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  3. Dec 2025 — Feb 2026 [monthly]

    Not Yet Recruiting PHASE3

  4. Nov 2025 — Dec 2025 [monthly]

    Not Yet Recruiting PHASE3

  5. Oct 2025 — Nov 2025 [monthly]

    Not Yet Recruiting PHASE3

Show 5 earlier versions
  1. Sep 2025 — Oct 2025 [monthly]

    Not Yet Recruiting PHASE3

  2. Aug 2025 — Sep 2025 [monthly]

    Not Yet Recruiting PHASE3

  3. Jul 2025 — Aug 2025 [monthly]

    Not Yet Recruiting PHASE3

  4. Jun 2025 — Jul 2025 [monthly]

    Not Yet Recruiting PHASE3

  5. May 2025 — Jun 2025 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .