A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Condition(s) studied
Investigational drug(s) / intervention(s)
KarXT: KarXT 20/2 mg (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)
Placebo: Placebo capsules
Study summary
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.
Eligibility
Primary outcome measure(s)
- Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score — Baseline and end of Treatment (up to 14 Weeks)
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Trial sites (154)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 1116 | Chandler | Arizona | Active Not Recruiting |
| Local Institution - 1044 | Phoenix | Arizona | Active Not Recruiting |
| Local Institution - 1104 | Anaheim | California | Active Not Recruiting |
| Local Institution - 1119 | Canoga Park | California | Active Not Recruiting |
| Local Institution - 1151 | Encino | California | Active Not Recruiting |
| Local Institution - 1142 | Lancaster | California | Active Not Recruiting |
| Local Institution - 1117 | Los Alamitos | California | Active Not Recruiting |
| Local Institution - 1103 | Sherman Oaks | California | Active Not Recruiting |
| Local Institution - 1007 | Walnut Creek | California | Active Not Recruiting |
| Local Institution - 1160 | Apopka | Florida | Withdrawn |
| Local Institution - 1156 | Clermont | Florida | Active Not Recruiting |
| Local Institution - 1138 | Cutler Bay | Florida | Active Not Recruiting |
| Local Institution - 1162 | Delray Beach | Florida | Active Not Recruiting |
| Local Institution - 1164 | Doral | Florida | Active Not Recruiting |
| Local Institution - 1165 | Fort Myers | Florida | Active Not Recruiting |
| Local Institution - 1155 | Hialeah | Florida | Active Not Recruiting |
| Local Institution - 1107 | Hialeah | Florida | Active Not Recruiting |
| Local Institution - 1120 | Hialeah | Florida | Active Not Recruiting |
| Local Institution - 1140 | Hialeah | Florida | Active Not Recruiting |
| Local Institution - 0150 | Homestead | Florida | Active Not Recruiting |
| Local Institution - 1145 | Homestead | Florida | Active Not Recruiting |
| Local Institution - 1127 | Largo | Florida | Active Not Recruiting |
| Local Institution - 1039 | Maitland | Florida | Active Not Recruiting |
| Local Institution - 1146 | Maitland | Florida | Active Not Recruiting |
| Local Institution - 1159 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1118 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1111 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1108 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1125 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1115 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1143 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1113 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1009 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1129 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1150 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1109 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1158 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1147 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1105 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1157 | Miami | Florida | Active Not Recruiting |
+ 114 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06126224 on ClinicalTrials.gov ↗ ← All trials in South Korea