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

Recruiting now Phase 3 NCT06937229

Run by Bristol-Myers Squibb · for 55 to 90 · All sexes

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

Participants must have completed study CN012-0023 or CN012-0024 per protocol.
Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

🚫 You may not be able to join if…

Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Local Institution - 2609, Chandler, Arizona, United States
Imaging Endpoints, Scottsdale, Arizona, United States
Local Institution - 1657, Anaheim, California, United States
Local Institution - 2620, Canoga Park, California, United States
Local Institution - 1637, La Jolla, California, United States
Local Institution - 2625, Long Beach, California, United States
Local Institution - 2607, Long Beach, California, United States
Local Institution - 2642, Long Beach, California, United States
Local Institution - 2649, Orange, California, United States
Local Institution - 2613, Pasadena, California, United States
Local Institution - 1662, Pomona, California, United States
Local Institution - 1639, Torrance, California, United States

+ 244 more sites.

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · 855-907-3286 · Clinical.Trials@bms.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06937229.

Open the interactive checklist for this trial →

Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.

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