RecruitingPhase 3

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

United States, Argentina, Brazil600 participantsStarted 2025-12-02

Plain-language 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.

Who can participate

Age range

55 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants must have completed study CN012-0023 or CN012-0024 per protocol. * Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more). Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since ADAGIO-3 is primarily measuring how many people experience treatment-emergent side effects, what does that tell us about how much is still unknown regarding the long-term safety of KarXT for agitation in Alzheimer's disease?
2This is a Phase 3 trial focused on long-term safety — how does that compare to what's already been established about KarXT in earlier studies, and would starting with any currently approved treatments for agitation make more sense for our situation?
3What kinds of side effects have been reported with KarXT in previous Alzheimer's agitation studies that we should be watching for if this trial is worth discussing with you further?
4Given that this trial is looking at long-term outcomes, what kind of time commitment and follow-up visits would be involved, and how might that fit into our current care routine?
5Are there any features of the disease stage or current medications that would make someone a poor fit for a trial like this, so we know what questions to bring to the research team??

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately Week 30

Trial details

NCT IDNCT06937229

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-06-22

Contact for this trial

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

View on ClinicalTrials.gov More Alzheimer Disease trials