A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
← catalyst calendarNCT06947941 · readout in 551 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
325estimated
Sites
22
Countries
Australia, Canada, Japan +2
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 | 2026-03-25 | actual | When the study began enrolling |
| Primary completion | 2028-02-21 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-03-20 | estimated | The whole study's end, after follow-up |
| First posted | 2025-04-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Alzheimer Disease
- Psychosis
Interventions
- Drug: KarXT — also filed as BMS-986510, Xanomeline/Trospium Chloride
- Drug: KarX-EC — also filed as BMS-986519, Xanomeline Enteric-coated
- Drug: KarXT + KarX-EC Arm Matching Placebo
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score
measured Up to approximately Week 14
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