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Long-term KarXT plus KarX-EC treatment for agitation in Alzheimer’s disease

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)

Phase 3 Interventional Bristol-Myers Squibb · NCT06937229

This will test whether taking KarXT together with KarX-EC reduces agitation and is safe long-term in people with Alzheimer’s disease who completed the earlier parent studies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment600 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations243 sites (Chandler, Arizona and 242 other locations)
Trial IDNCT06937229 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial enrolls participants who completed parent studies CN012-0023 or CN012-0024 to receive a combined regimen of immediate-release KarXT and enteric KarX-EC capsules over an extended treatment period. Efficacy for agitation symptoms will be tracked alongside systematic safety monitoring, including cardiovascular and other adverse events, with regular clinic visits and caregiver-reported outcomes. An identified caregiver with approximately 10 hours per week contact is required to provide collateral information and support study procedures. The trial is sponsored by Bristol-Myers Squibb and conducted at selected U.S. clinical sites.

Who should consider this trial

Good fit: People with Alzheimer’s who experienced agitation, completed parent studies CN012-0023 or CN012-0024, and have a caregiver who can provide regular contact and support are the intended participants.

Not a fit: People with unstable or clinically significant cardiovascular, pulmonary, renal, neurological, or other serious medical conditions, or those who did not participate in the parent studies, are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this could provide a new long-term oral option to reduce agitation in people with Alzheimer’s and ease caregiver burden.

How similar studies have performed: Short-term trials of xanomeline formulations have shown promise for neuropsychiatric symptoms, and this trial builds on those findings by testing long-term combined KarXT/KarX-EC treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chandler, Arizona and 242 other locations

+193 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseaseAgitationAlzheimer diseaseKarXTKarX-EC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.