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
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 range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugKarXT
Specified dose on specified days
- DrugKarX-EC
Specified dose on specified days
Locations (241)
- Local Institution - 2609Chandler, Arizona
- Imaging EndpointsScottsdale, Arizona
- Local Institution - 1657Anaheim, California
- Local Institution - 2620Canoga Park, California
- Local Institution - 1637La Jolla, California
- Local Institution - 2625Long Beach, California