🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06585787
Recruiting Phase 3

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

NCT06585787 · tracked via the Priya Life Science India tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 3
Started
2024-09-26
Last updated
2026-08-26

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

KarXTPlacebo

KarXT: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria * Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. * Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation). Exclusion Criteria \- Patients will not be able to participate if they have: i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. \* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Trial sites (293)

FacilityCityRegionStatus
Local Institution - 1227 Chandler Arizona Completed
Gilbert Neurology Partners - PLLC - Avacare Gilbert Arizona Recruiting
Banner Alzheimer's Institute Phoenix Arizona Recruiting
Local Institution - 1220 Scottsdale Arizona Completed
Advanced Research Center, Inc. Anaheim California Recruiting
Inland Psychiatric Medical Group (IPMG)-Chino Chino California Recruiting
Local Institution - 1230 Long Beach California Completed
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) Los Angeles California Recruiting
Local Institution - 1219 Los Angeles California Withdrawn
Local Institution - 1001 Orange California Completed
Local Institution - 1228 Orange California Completed
Local Institution - 1043 Pasadena California Active Not Recruiting
Local Institution - 1213 Rancho Cucamonga California Active Not Recruiting
University of Connecticut Health Center Farmington Connecticut Recruiting
Local Institution - 1225 Atlantis Florida Completed
Envision Trials LLC Bonita Springs Florida Recruiting
Local Institution - 1138 Cutler Bay Florida Active Not Recruiting
Arrow Clinical Trials Daytona Beach Florida Recruiting
Local Institution - 1224 Deerfield Beach Florida Completed
Local Institution - 1164 Doral Florida Active Not Recruiting
Local Institution - 1264 Gulf Breeze Florida Not Yet Recruiting
Local Institution - 1120 Hialeah Florida Active Not Recruiting
Local Institution - 1237 Hialeah Florida Completed
Local Institution - 1229 Homestead Florida Active Not Recruiting
Local Institution - 1040 Lady Lake Florida Completed
Local Institution - 1159 Miami Florida Active Not Recruiting
Local Institution - 1021 Miami Florida Active Not Recruiting
Local Institution - 1125 Miami Florida Active Not Recruiting
Local Institution - 1236 Miami Florida Active Not Recruiting
Local Institution - 1115 Miami Florida Active Not Recruiting
Local Institution - 1010 Miami Florida Completed
Local Institution - 1143 Miami Florida Completed
Local Institution - 1113 Miami Florida Active Not Recruiting
Local Institution - 1129 Miami Florida Active Not Recruiting
Local Institution - 1150 Miami Florida Active Not Recruiting
Local Institution - 1006 Miami Florida Active Not Recruiting
Local Institution - 1111 Miami Florida Active Not Recruiting
Local Institution - 1158 Miami Florida Completed
Local Institution - 1235 Miami Florida Completed
Local Institution - 1147 Miami Florida Completed

+ 253 more sites — see the full list on the official registry below.

More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in India

Other trials for the same condition

Official registry record

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 NCT06585787 on ClinicalTrials.gov ↗ ← All trials in India