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Long-Term Study of KarXT and KarX-EC for Agitation in Alzheimer's Disease

This study is looking at the long-term effects of two medications, KarXT and KarX-EC, for people with agitation (restlessness or distress) due to Alzheimer's disease. You can join if you are between 55 and 90 years old and have already completed a previous study (CN012-0023 or CN012-0024) involving these medications. You also need a caregiver who spends at least 8 hours a week with you. The main goal is to track any side effects you might experience over about 30 weeks. This study aims to understand how safe and effective these treatments are over a longer period.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 650 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events (side effects) for up to approximately Week 30.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06937229

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

Recruiting
PHASE3Ages 55–90InterventionalTreatment
Bristol-Myers Squibb
~650 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:KarXTKarX-EC

At a glance

Recruiting sites
47 of 256 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured over Up to approximately Week 30

Conditions

Alzheimer Disease
Agitation

Explore related trials

AgitationAlzheimer's Disease

Where it's being run

256 sites across 108 states
Spain11
California9
Argentina9
Florida8
Romania8
United Kingdom8
Poland7
Bucharest7

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)Up to approximately Week 30