Recruiting

Phase 3

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

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT06585787

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

KarXT

Placebo

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT06585787

Start date

Sep 26, 2024

Status verified date

Aug, 2026

Completion date

Dec 22, 2026

Anticipated

Primary completion date

Nov 24, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

406 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

experimental: Placebo

Interventions

KarXT

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score [ Time Frame: Up to Week 14 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

Gilbert Neurology Partners - PLLC - Avacare

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Jonathan Hodgson, Site 1247

602-761-9631

Banner Alzheimer's Institute

Recruiting

Phoenix, Arizona, United States, 85006-2528

Contacts

Ganesh Gopalakrishna, Site 1217

602-839-6900

Advanced Research Center, Inc.

Recruiting

Anaheim, California, United States, 92805-5854

Contacts

Steven Macina, Site 1104

714-999-6688

Inland Psychiatric Medical Group (IPMG)-Chino

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 1244

909-488-9116

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)

Recruiting

Los Angeles, California, United States, 90033-5313

Contacts

Lon Schneider, Site 1226

323-442-3715

University of Connecticut Health Center

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

Neha Jain, Site 1222

860-790-7354

Envision Trials LLC

Recruiting

Bonita Springs, Florida, United States, 34134

Contacts

Daniel Mandri, Site 1020

305-819-2909

Arrow Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117-5532

Contacts

David Billmeier, Site 1023

386-278-8000

Aqualane Clinical Research

Recruiting

Naples, Florida, United States, 34105

Contacts

William Justiz, Site 1246

941-436-6838

Sensible HealthCare, LLC

Recruiting

Ocoee, Florida, United States, 34761-2964

Contacts

Kelly Taylor, Site 1212

407-654-2724

Charter Research Orlando

Recruiting

Orlando, Florida, United States, 32803

Nova Psychiatry

Recruiting

Orlando, Florida, United States, 32803

Contacts

David Medina, Site 1242

407-823-8421

Combined Research Orlando Phase I-IV LLC

Recruiting

Orlando, Florida, United States, 32807-3555

Contacts

Eric Carbonell, Site 1112

407-440-4493

Guardian Angel Research

Recruiting

Tampa, Florida, United States, 33614

Contacts

Sadaf Bazargan, Site 1124

813-300-3300

Interventional Psychiatry of Tampa Bay

Recruiting

Tampa, Florida, United States, 33629-5837

Contacts

Jamie Fernandez, Site 1110

813-251-1800

Charter Research

Recruiting

The Villages, Florida, United States, 32162-2698

Contacts

Jeffrey Norton, Site 1256

352-775-1000

Premiere Research Institute at Palm Beach Neurology, PA

Recruiting

West Palm Beach, Florida, United States, 33407-3209

Contacts

Paul Winner, Site 1216

561-845-0500

Agile Clinical Research Trials, LLC

Recruiting

Atlanta, Georgia, United States, 30328-5532

Contacts

Vasundhara Cheekati, Site 1206

404-382-8660

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478-1064

Contacts

Arkadiy Stolyar, Site 1223

617-855-2136

Tufts Medical Center - 800 Washington St - PPDS

Recruiting

Boston, Massachusetts, United States, 02111-1552

Contacts

Brent Forester, Site 1245

617-636-3202

Boston Neuro Research Center

Recruiting

North Dartmouth, Massachusetts, United States, 02747-2612

Contacts

Mushtaque Chachar, Site 1243

508-925-7403

Elixia Health - Springfield - Elixia - PPDS

Recruiting

Springfield, Massachusetts, United States, 01103

Contacts

Susan Smiga, Site 1239

413-305-1142

Neurobehavioral Medicine Group (NBMG)

Recruiting

Bloomfield Township, Michigan, United States, 48302-1909

Contacts

Richard Jackson, Site 1248

412-916-2425

Precise Research Centers

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Joseph Kwentus, Site 1132

601-420-5810

Tekton Research, LLC - Saint Louis Psychiatry - PPDS

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Ernest Graypel, Site 1255

314-594-7785

Advanced Memory Research Institute - CenExel - PPDS

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Arun Singh, Site 1202

732-341-9500

Mid Hudson Medical Research PLLC

Recruiting

New Windsor, New York, United States, 12553-7754

Contacts

Sashi Makam, Site 1251

845-674-9398

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210-2306

Contacts

Tinatin Chabrashvili, Site 1240

617-636-5000

Five Towns Neurology, PC

Recruiting

Woodmere, New York, United States, 11598-1739

Contacts

David Steiner, Site 1025

516-239-1800

Triad Clinical Trials - 515 College Rd

Recruiting

Greensboro, North Carolina, United States, 27410-3311

Contacts

Richard Montgomery, Site 1221

336-235-0991

AMC Research, LLC - Flourish - PPDS

Recruiting

Matthews, North Carolina, United States, 28105-8336

Contacts

Mohammad Bolouri, Site 1214

704-364-4000

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Patrick Morgante, Site 1215

252-515-0050

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Douglas Scharre, Site 1201

614-293-4560

Insight Clinical Trials LLC - Independence

Recruiting

Independence, Ohio, United States, 44131

Contacts

Mark Stillman, Site 1249

216-444-8897

The Rivus Wellness & Research Institute

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

Marvin Peyton, Site 1016

405-317-5783

Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Chuang-Kuo Wu, Site 1218

714-456-7002

Vanderbilt Psychiatric Hospital

Recruiting

Nashville, Tennessee, United States, 37212-3133

Contacts

Jo Wilson, Site 1211

615-322-4967

Senior Adults Specialty Research

Recruiting

Austin, Texas, United States, 78757-7566

Contacts

John Bertelson, Site 1263

512-407-8628

Epic Medical Research LLC - DeSoto

Recruiting

DeSoto, Texas, United States, 75115-2043

Contacts

Haresh Boghara, Site 1121

972-777-6956

Advanced Neuro Research Center - El Paso

Recruiting

El Paso, Texas, United States, 79912-1743

Contacts

Aamr Herekar, Site 1208

915-974-2200

University Hills Clinical Research - 102 Decker Ct

Recruiting

Irving, Texas, United States, 75062-2898

Contacts

Mary Ann Knesevich, Site 1259

972-717-6262

Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

Recruiting

San Antonio, Texas, United States, 78229-3901

Contacts

Antonio Teixeira, Site 1210

210-567-8229

Conquest Research, LLC - Virginia - Vienna

Recruiting

Vienna, Virginia, United States, 22182

Contacts

Henry Tran, Site 1241

703-717-7755

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007-4879

Contacts

Wisam Al Jumaili, Site 1253

425-453-0404

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

Alzheimer's Disease
AD
ADEPT4
ADEPT-4
KarXT
Psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-08-26.