Phase 3RecruitingAge-related condition
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company (Industry)
- Enrolment
- 500 planned
- Conditions
- Psychosis Associated With Alzheimer's Disease
- Interventions
- KarXT; Placebo
- Ages
- adults, older adults
- Registry
- NCT06126224, CTIS2023-504416-16-00
Full record on ClinicalTrials.gov
From the registry
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Primary outcomes
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
History
Primary completion expected
Last registry update
Registered
Started