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Recruiting Phase 3 Interventional

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

ClinicalTrials.gov ID: NCT06126224

Public ClinicalTrials.gov record NCT06126224. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06126224
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
500 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 27, 2023
Primary completion
Dec 8, 2026
Completion
Dec 8, 2026
Last update posted
Sep 3, 2026

2023 – 2026

United States locations

U.S. sites
70
U.S. states
13
U.S. cities
46
Facility City State ZIP Site status
Local Institution - 1116 Chandler Arizona 85286 Active, not recruiting
Local Institution - 1044 Phoenix Arizona 85012-2836 Active, not recruiting
Local Institution - 1104 Anaheim California 92805-5854 Active, not recruiting
Local Institution - 1119 Canoga Park California 91303-1844 Active, not recruiting
Local Institution - 1151 Encino California 91316 Active, not recruiting
Local Institution - 1142 Lancaster California 93534-2839 Active, not recruiting
Local Institution - 1117 Los Alamitos California 90720-6506 Active, not recruiting
Local Institution - 1103 Sherman Oaks California 91403-2131 Active, not recruiting
Local Institution - 1007 Walnut Creek California 94596 Active, not recruiting
Local Institution - 1160 Apopka Florida 32703-5835 Withdrawn
Local Institution - 1156 Clermont Florida 34711-5190 Active, not recruiting
Local Institution - 1138 Cutler Bay Florida 33189-1230 Active, not recruiting
Local Institution - 1162 Delray Beach Florida 33445-2581 Active, not recruiting
Local Institution - 1164 Doral Florida 33122-1620 Active, not recruiting
Local Institution - 1165 Fort Myers Florida 33912-4302 Active, not recruiting
Local Institution - 1155 Hialeah Florida 33012-3158 Active, not recruiting
Local Institution - 1107 Hialeah Florida 33012-3618 Active, not recruiting
Local Institution - 1120 Hialeah Florida 33012-4648 Active, not recruiting
Local Institution - 1140 Hialeah Florida 33016-1814 Active, not recruiting
Local Institution - 0150 Homestead Florida 33032-8187 Active, not recruiting
Local Institution - 1145 Homestead Florida 33032-8187 Active, not recruiting
Local Institution - 1127 Largo Florida 33777-1359 Active, not recruiting
Local Institution - 1039 Maitland Florida 32751-5669 Active, not recruiting
Local Institution - 1146 Maitland Florida 32751-6138 Active, not recruiting
Local Institution - 1159 Miami Florida 33032 Active, not recruiting
Local Institution - 1118 Miami Florida 33122-1721 Active, not recruiting
Local Institution - 1111 Miami Florida 33126-5683 Active, not recruiting
Local Institution - 1108 Miami Florida 33133-4231 Active, not recruiting
Local Institution - 1125 Miami Florida 33135-1601 Active, not recruiting
Local Institution - 1115 Miami Florida 33135 Active, not recruiting
Local Institution - 1143 Miami Florida 33145-2455 Active, not recruiting
Local Institution - 1113 Miami Florida 33155-6630 Active, not recruiting
Local Institution - 1009 Miami Florida 33155 Active, not recruiting
Local Institution - 1129 Miami Florida 33165-3947 Active, not recruiting
Local Institution - 1150 Miami Florida 33165 Active, not recruiting
Local Institution - 1109 Miami Florida 33174-2950 Active, not recruiting
Local Institution - 1158 Miami Florida 33175 Active, not recruiting
Local Institution - 1147 Miami Florida 33176-7947 Active, not recruiting
Local Institution - 1105 Miami Florida 33179-2537 Active, not recruiting
Local Institution - 1157 Miami Florida 33184-1412 Active, not recruiting
Local Institution - 1126 Miami Gardens Florida 33056-4000 Completed
Local Institution - 1102 Miami Lakes Florida 33014-6435 Completed
Local Institution - 1136 Orlando Florida 32806-1041 Active, not recruiting
Local Institution - 1112 Orlando Florida 32807-3555 Active, not recruiting
Local Institution - 1137 Port Orange Florida 32127-2914 Active, not recruiting
Health Synergy Clinical Research,LLC - Stuart Stuart Florida 34994 Recruiting
Local Institution - 1133 Sweetwater Florida 33182 Active, not recruiting
Local Institution - 1041 Tampa Florida 33607-4629 Active, not recruiting
Local Institution - 1124 Tampa Florida 33614-2700 Active, not recruiting
Local Institution - 1123 Tampa Florida 33614-2869 Completed
Local Institution - 1110 Tampa Florida 33629-5837 Active, not recruiting
Local Institution - 1040 The Villages Florida 32159-8986 Withdrawn
Local Institution - 1131 Viera Florida 32940 Recruiting
Local Institution - 1152 Augusta Georgia 30912-0020 Withdrawn
Local Institution - 1141 Columbus Georgia 31909-1693 Withdrawn
Local Institution - 1161 Decatur Georgia 30030 Active, not recruiting
Local Institution - 1148 Elgin Illinois 60123-9215 Active, not recruiting
Local Institution - 1114 Marrero Louisiana 70072-3083 Active, not recruiting
Local Institution - 1139 Rochester Hills Michigan 48307-2760 Active, not recruiting
Local Institution - 1132 Flowood Mississippi 39232 Active, not recruiting
Local Institution - 1144 Las Vegas Nevada 89106-4145 Withdrawn
Local Institution - 1153 New Hyde Park New York 11042-2062 Withdrawn
Local Institution - 1135 Port Jefferson Station New York 11776-3386 Withdrawn
Local Institution - 1122 Dayton Ohio 45459-4248 Active, not recruiting
Local Institution - 1149 Malvern Pennsylvania 19355-3267 Withdrawn
Local Institution - 1106 Cypress Texas 77429-6070 Recruiting
Local Institution - 1163 Houston Texas 77074-2085 Active, not recruiting
Local Institution - 1154 Katy Texas 77450-1759 Active, not recruiting
Local Institution - 1121 Red Oak Texas 75154 Withdrawn
Local Institution - 1134 Stafford Texas 77477-3929 Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 84 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06126224, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 3, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06126224 live on ClinicalTrials.gov.

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