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ADAGIO-2: KarXT + KarX-EC for Agitation in Alzheimer's Disease
NCT07011745Phase 3
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Nov 2028
- Countries
- 14
- Sponsor
- Bristol Myers Squibb
- Conditions
- Alzheimer's disease (AD)
01
Overview
Phase 3, randomised, double-blind trial in Alzheimer's disease (AD) comparing KarXT + KarX-EC with Placebo (2 arms). Primary endpoint: Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association at 14 weeks. Started Jul 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
KarXT + KarX-EC
Experimental arm receiving Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule
Placebo
Placebo comparator arm
03
Who it enrols
Adults with Alzheimer's disease and agitation, MMSE <= 24, with an identified caregiver. Excludes patients with other psychiatric disorders, high suicidal risk, or taking certain psychoactive medications.
04
Endpoints
Primary
Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association
Secondary
Clinical Global Impressions-Severity
Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association Domains
Cohen-Mansfield Agitation Inventory
Occurrence of Response
Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home
Adverse Events
Treatment Emergent Adverse Events
Serious Adverse Events
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