Status:
RECRUITING
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer Disease
Agitation
Eligibility:
All Genders
55-90 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2029
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06937229
Start Date
December 2 2025
End Date
July 20 2029
Last Update
January 8 2026
Active Locations (241)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 2609
Chandler, Arizona, United States, 85224
2
Local Institution - 1619
Scottsdale, Arizona, United States, 85258
3
Local Institution - 1657
Anaheim, California, United States, 92805
4
Local Institution - 2620
Canoga Park, California, United States, 91303