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KarXT + KarX-EC in Agitation Associated With Alzheimer's Disease
NCT07011732Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Nov 2028
- Countries
- 15
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules, Drug Delivery Systems
- Conditions
- agitation
01
Overview
Phase 3, randomised, double-blind trial in agitation comparing KarXT + KarX-EC with Placebo (2 arms). Primary endpoint: Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association Total Score at 14 weeks. Started Jul 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
KarXT + KarX-EC
Xanomeline/Trospium Chloride Capsule + Xanomeline Enteric Capsule
Placebo
Placebo capsules
03
Who it enrols
Participants must have Alzheimer's disease with confirmed pathology, an MMSE score <= 24, a history of agitation, NPI/NPI-NH Agitation/Aggression score >= 4, CMAI-IPA Total Score >= 30, and an identified caregiver. Excludes patients with agitation from other causes, severe psychiatric disorders, suicidal risk, or recent use of certain psychoactive medications.
04
Endpoints
Primary
Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association Total Score
Secondary
Clinical Global Impressions-Severity
Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association Domains
Cohen-Mansfield Agitation Inventory Total Score
Occurrence of Response
Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home Total Score
Adverse Events
Treatment Emergent Adverse Events
Serious Adverse Events
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