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

RECRUITINGPhase 3Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 3
SponsorBristol-Myers Squibb
Started2025-12-02
Est. completion2029-06-22
Eligibility
Age55 Years – 90 Years
Healthy vol.Accepted
Locations48 sites
View on ClinicalTrials.gov →

NCT06937229

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.

Eligibility

Age: 55 Years – 90 YearsHealthy volunteers accepted
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.

Conditions3

AgitationAlzheimer DiseaseAlzheimer's Disease

Locations48 sites

Local Institution - 2609
Chandler, Arizona, 85224
Site 2609
Imaging Endpoints
Scottsdale, Arizona, 85258
Nida Laurin, Site 1619480-290-1547
Local Institution - 1657
Anaheim, California, 92805
Site 1657
Local Institution - 2620
Canoga Park, California, 91303
Site 2620
Local Institution - 1637
La Jolla, California, 92037
Site 1637

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