ADAGIO-1: KarXT + KarX-EC for Agitation in Alzheimer's Disease
This study is testing a combination of two medications, KarXT and KarX-EC, to see if they can safely and effectively reduce agitation in people with Alzheimer's disease. We are looking for adults between 55 and 90 years old who have been diagnosed with Alzheimer's disease, confirmed by specific tests like amyloid PET scans or spinal fluid analysis. The main goal is to measure changes in agitation levels using a standard assessment tool after 14 weeks. The study plans to enroll 426 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It involves testing KarXT + KarX-EC, KarX-EC alone, or a placebo (an inactive substance) in about 426 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Week 14, indicating participants will be followed for at least that long.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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-1)
At a glance
Conditions
Where it's being run
159 sites across 69 statesStudy leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14At Week 14