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)
← catalyst calendarNCT07011732 · readout in 827 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
426estimated
Sites
159
Countries
Argentina, Brazil, Bulgaria +12
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-10 | actual | When the study began enrolling |
| Primary completion | 2028-11-24 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-12-08 | estimated | The whole study's end, after follow-up |
| First posted | 2025-06-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Alzheimer Disease
Interventions
- Drug: Xanomeline/Trospium Chloride Capsule — also filed as KarXT, BMS-986510
- Drug: Xanomeline Enteric Capsule — also filed as KarX-EC, BMS-986519
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14
measured At Week 14
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