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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

Testing KarXT + KarX-EC for Alzheimer's-related agitation.

Recruiting
55-90 years
All
Phase 3
**Study Summary** This study is checking how safe and effective a treatment called KarXT + KarX-EC is for adults with Alzheimer's Disease who experience agitation. Agitation means feeling restless or upset. **Eligibility:** Participants need to have Alzheimer's Disease confirmed by certain tests like a brain scan or blood test. They also need to have a history of agitation for at least two weeks before the study starts. They must have a caregiver who can help with the study and attend visits. **Exclusions:** People with other conditions causing agitation, like bipolar disorder, or those at risk for certain medical issues like glaucoma, can't join. Also, if they are on certain medications, they might not be eligible. **Key Points**: - The study involves multiple visits with a caregiver's help. - Participants may need to stop some medications before joining. - Safety of the treatment is a focus, so certain health risks will be assessed. This study is important to help find better ways to treat people with Alzheimer's who feel agitated, but not everyone can join, so careful checks are needed.
Study details
    Alzheimer Disease

NCT07011745

Bristol-Myers Squibb

7 March 2026

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