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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-1)

ClinicalTrials.gov ID: NCT05511363

Public ClinicalTrials.gov record NCT05511363. 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 10, 2026, 6:48 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 Relapse Prevention 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, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Study identification

NCT ID
NCT05511363
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
410 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 22, 2022
Primary completion
Oct 4, 2026
Completion
Oct 4, 2026
Last update posted
Aug 16, 2026

2022 – 2026

United States locations

U.S. sites
59
U.S. states
14
U.S. cities
41
Facility City State ZIP Site status
Local Institution - 1029 Homewood Alabama 35209-6809 Active, not recruiting
Local Institution - 1044 Phoenix Arizona 85012-2836 Completed
Local Institution - 1033 Encino California 91436-2201 Completed
Local Institution - 1031 Irvine California 92612-1246 Withdrawn
ATP Clinical Research-302 W La Veta Ave Orange California 92866 Recruiting
Local Institution - 1043 Pasadena California 91106 Completed
Local Institution - 1047 San Marcos California 92069-3595 Completed
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS Walnut Creek California 94596 Recruiting
Local Institution - 1014 Colorado Springs Colorado 80907-5302 Completed
Local Institution - 1013 Stamford Connecticut 06905-1206 Completed
Local Institution - 1011 Boca Raton Florida 33487-2768 Completed
Local Institution - 1020 Bonita Springs Florida 34134 Completed
Local Institution - 1015 Bradenton Florida 34209-4687 Completed
K2 Medical Research - Winter Garden Clermont Florida 34711-5933 Recruiting
Arrow Clinical Trials Daytona Beach Florida 32117-5532 Recruiting
Local Institution - 1045 Doral Florida 33172-2638 Active, not recruiting
Local Institution - 1046 Hialeah Florida 33012-5826 Active, not recruiting
Local Institution - 1024 Hialeah Florida 33012-5884 Withdrawn
Local Institution - 1052 Hialeah Florida 33012 Active, not recruiting
Local Institution - 1049 Homestead Florida 33032 Active, not recruiting
K2 Medical Research - Maitland Maitland Florida 32751-5669 Recruiting
Local Institution - 1021 Miami Florida 33122-1335 Active, not recruiting
Local Institution - 1005 Miami Florida 33125-3724 Completed
Local Institution - 1115 Miami Florida 33135 Active, not recruiting
Local Institution - 1010 Miami Florida 33137 Completed
Local Institution - 1143 Miami Florida 33145-2455 Completed
Local Institution - 1009 Miami Florida 33155-4630 Active, not recruiting
Local Institution - 1129 Miami Florida 33165-3947 Active, not recruiting
Local Institution - 1053 Miami Florida 33166 Active, not recruiting
Local Institution - 1006 Miami Florida 33173-1474 Active, not recruiting
Local Institution - 1111 Miami Florida 33173 Active, not recruiting
Local Institution - 1054 Miami Florida 33186-4643 Active, not recruiting
Local Institution - 1042 Miami Florida 33186-5882 Active, not recruiting
Local Institution - 1032 Miami Lakes Florida 33014-5602 Active, not recruiting
Local Institution - 1026 Miami Springs Florida 33166-5260 Active, not recruiting
Local Institution - 1027 Ocala Florida 34470-6657 Withdrawn
Local Institution - 1012 Pensacola Florida 32504-8608 Completed
Local Institution - 1008 St. Petersburg Florida 33713-8844 Active, not recruiting
University of South Florida Tampa Florida 33606 Recruiting
Local Institution - 1041 Tampa Florida 33607-4629 Completed
Local Institution - 1040 The Villages Florida 32159-8986 Withdrawn
Local Institution - 1037 Chicago Illinois 60623 Completed
Local Institution - 1018 Manhasset New York 11030-3816 Active, not recruiting
Local Institution - 1-14IL3BJP New York New York 10003-1759 Not yet recruiting
Local Institution - 1030 New York New York 10016 Withdrawn
Local Institution - 1051 New York New York 10032-3720 Completed
Local Institution - 1017 New York New York 10032 Completed
Local Institution - 1002 Staten Island New York 10314-1607 Active, not recruiting
Local Institution - 1034 Stony Brook New York 11794-0001 Completed
Five Towns Neurology, PC Woodmere New York 11598-1739 Recruiting
Local Institution - 1003 Canton Ohio 44718 Withdrawn
Local Institution - 1028 Oklahoma City Oklahoma 73104-5007 Withdrawn
Local Institution - 1016 Oklahoma City Oklahoma 73112 Completed
Local Institution - 1019 Allentown Pennsylvania 18103 Completed
Local Institution - 1035 Charleston South Carolina 29425-8900 Completed
Local Institution - 1038 Franklin Tennessee 37067-5922 Completed
Local Institution - 1022 Flower Mound Texas 75028-2011 Completed
Local Institution - 1036 Frisco Texas 75034-6262 Completed
Clinical Trial Network - 7080 Southwest Fwy Houston Texas 77074-2085 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 67 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05511363, 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 Aug 16, 2026 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05511363 live on ClinicalTrials.gov.

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