A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
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)
Bristol-Myers Squibb
600 participants
Dec 2, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria1
- 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.
Interventions
Specified dose on specified days
Specified dose on specified days
Locations(241)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06937229