RECRUITING

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

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Conditions

Alzheimer DiseaseAlzheimer's DiseaseADADEPT4ADEPT-4KarXTPsychosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-09-26
Study Completion:2026-11-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06585787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 1217
Phoenix, Arizona, 85006-2528
United States
Local Institution - 1220
Scottsdale, Arizona, 85260-6742
United States
Local Institution - 1104
Anaheim, California, 92805-5854
United States
ATP Clinical Research
Costa Mesa, California, 92626-4607
United States
Local Institution - 1219
Los Angeles, California, 90095
United States
Local Institution - 1213
Rancho Cucamonga, California, 91730
United States
Local Institution - 1222
Farmington, Connecticut, 06030
United States
JY Research Institute Inc
Cutler Bay, Florida, 33189-1232
United States
Local Institution - 1023
Daytona Beach, Florida, 32117-5531
United States
Integrity Clinical Research, Llc
Doral, Florida, 33122-1620
United States
Local Institution - 1118
Doral, Florida, 33122-1713
United States
New Life Medical Research Center
Hialeah, Florida, 33012-4654
United States
Local Institution - 1159
Homestead, Florida, 33032-8225
United States
New Med Research
Miami Gardens, Florida, 33056-4000
United States
Local Institution - 1209
Miami Lakes, Florida, 33014
United States
Local Institution - 1115
Miami Lakes, Florida, 33016
United States
Local Institution - 1021
Miami, Florida, 33122-1351
United States
Dade Research Center, LLC
Miami, Florida, 33126-5686
United States
Wellness Research Center Inc - Miami
Miami, Florida, 33135-1601
United States
Local Institution - 1010
Miami, Florida, 33137-2706
United States
Cordova Research Institute
Miami, Florida, 33155-6541
United States
Future Care Solution LLC
Miami, Florida, 33165-3947
United States
Local Institution - 1150
Miami, Florida, 33165
United States
Novel Clinical Research Center, LLC.
Miami, Florida, 33173-1494
United States
Local Institution - 1158
Miami, Florida, 33175
United States
Local Institution - 1212
Ocoee, Florida, 34761-2964
United States
Local Institution - 1112
Orlando, Florida, 32807-3555
United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174-3101
United States
Local Institution - 1205
Port Orange, Florida, 32127-5169
United States
Local Institution - 1123
Tampa, Florida, 33614-2869
United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629-5837
United States
Local Institution - 1216
West Palm Beach, Florida, 33407-3209
United States
Local Institution - 1206
Atlanta, Georgia, 30328-5532
United States
Local Institution - 1223
Belmont, Massachusetts, 02478
United States
Local Institution - 1132
Flowood, Mississippi, 39232-8839
United States
Local Institution - 1202
Toms River, New Jersey, 08755
United States
Local Institution - 1221
Greensboro, North Carolina, 27410-3311
United States
Local Institution - 1214
Matthews, North Carolina, 28105-8335
United States
Local Institution - 1215
Morehead City, North Carolina, 28557
United States
Local Institution - 1201
Columbus, Ohio, 43221-3502
United States
Local Institution - 1218
Providence, Rhode Island, 02903
United States
Local Institution - 1211
Nashville, Tennessee, 37212
United States
Local Institution - 1208
El Paso, Texas, 79912
United States
Local Institution - 1210
San Antonio, Texas, 78229-3901
United States
R & H Clinical Research-3727 Greenbriar Dr
Stafford, Texas, 77477-3954
United States

Collaborators and Investigators

Sponsor: Karuna Therapeutics

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26
Study Completion Date2026-11-06

Study Record Updates

Study Start Date2024-09-26
Study Completion Date2026-11-06

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer's Disease
  • AD
  • ADEPT4
  • ADEPT-4
  • KarXT
  • Psychosis

Additional Relevant MeSH Terms

  • Alzheimer Disease