A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Phase 3

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: KarXT; Drug: Placebo

• Registration Number: NCT06585787
• Lead Sponsor: Karuna Therapeutics

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-08-30
• Study First Posted: 2024-09-19
• Study Start: 2024-09-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-14
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-09-21
• Study Completion: 2026-10-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KarXT	KarXT	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score	Up to Week 14

Secondary Outcome Measures

Name	Time	Method
Change from baseline in NPI-C Core score: Agitation Domain	Up to Week 14
Change from baseline in NPI-C Core score: Aggression Domain	Up to Week 14
Change from baseline in NPI-C Agitation score	Up to Week 14
Change from baseline in Cohen- Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score	Up to Week 14
Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score	Up to Week 14
Number of participants with Adverse Events (AEs)	Up to Week 14
Number of participants with Treatment-Emergent Adverse Events (TEAEs)	Up to Week 14
Number of participants with Serious Adverse Events (SAEs)	Up to Week 14
Number of participants with procholinergic symptoms	Up to Week 14
Number of participants with anticholinergic symptoms	Up to Week 14
Number of participants with AEs of Special Interest (AESIs)	Up to Week 14
Barnes Akathisia Rating Scale (BARS) Score	Up to Week 14
Number of participants with vital sign abnormalities	Up to Week 14
Number of participants with clinical laboratory abnormalities	Up to Week 14
Number of participants with 12-lead electrocardiogram (ECG) abnormalities	Up to Week 14
Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	Up to Week 14
Cognition as assessed by the Mini-Mental State Examination (MMSE)	Up to Week 14
Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)	Up to Week 14
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale	Up to Week 14
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain	Up to Week 14
Change from baseline in NPI-C Core score: Delusion Domain	Up to Week 14
Change from baseline in NPI-C Core score: Caregiver Distress Scale	Up to Week 14
Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score	Up to Week 14
Number of participants with TEAEs leading to study withdrawal	Up to Week 14
Abnormal Involuntary Movement Scale (AIMS) Score	Up to Week 14
Body Weight	Up to Week 14
Body Mass Index (BMI)	Up to Week 14

Trial Locations

Locations (232)

Chandler Clinical Trials, LLC; 🇺🇸 Chandler, Arizona, United States

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Scottsdale Clinical Trials; 🇺🇸 Scottsdale, Arizona, United States

Advanced Research Center, Inc.; 🇺🇸 Anaheim, California, United States

Local Institution - 1244; 🇺🇸 Chino, California, United States

Long Beach Research Institute, LLC; 🇺🇸 Long Beach, California, United States

Local Institution - 1226; 🇺🇸 Los Angeles, California, United States

Local Institution - 1219; 🇺🇸 Los Angeles, California, United States

ATP Clinical Research-302 W La Veta Ave; 🇺🇸 Orange, California, United States

NRC Research Institute - Orange - PPDS; 🇺🇸 Orange, California, United States

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