Clinical Trial

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

Recruiting Phase 3
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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.
Protocol Amendment History 1 change
notable Trial sites expanded: 243 -> 253 locations 2026-05-23
Trial Details
NCT Number NCT06937229
Lead Sponsor Bristol-Myers Squibb
Conditions Alzheimer Disease, Agitation
Enrollment 650 participants
Start Date 2025-12-02
Primary Completion 2029-06-22 (estimated)
Study Completion 2029-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-28