Recruiting
Phase 3

KarXT

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT05980949

Conditions

Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

KarXT

Study Details

Brief summary:

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Conditions

Psychosis Associated With Alzheimer's Disease

Study ID

NCT05980949

Start date

Jul 11, 2023

Status verified date

Jun, 2026

Completion date

Sep 7, 2027

Anticipated

Primary completion date

Sep 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
  • Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:

1. The subject's legally acceptable representative (LAR) must provide IC
2. The subject must provide informed assent
  • Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.

Exclusion Criteria:

  • Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
  • Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
  • Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

Xanomeline and Trospium Chloride Capsules

Interventions

KarXT

KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

Primary outcome measure

  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From initial dose through 14 days after the final dose (up to 54 weeks) ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Advanced Research Center, Inc.

Recruiting

Anaheim, California, United States, 92805-5854

Contacts

Steven Macina, Site 1104

714-999-6688

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

SC3 Research - Pasadena - 960 E. Green St

Recruiting

Pasadena, California, United States, 91106

Contacts

M. Lorraine Purino, Site 1043

626-250-2070

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Ira Glick, Site 1007

925-298-5147

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

K2 Medical Research - Winter Garden

Recruiting

Clermont, Florida, United States, 34711-5933

Contacts

Christopher Galloway, Site 1048

321-500-5252

JY Research Institute Inc

Recruiting

Cutler Bay, Florida, United States, 33189-1230

Contacts

Suez Oramas Mingo, Site 1138

305-424-8696

Arrow Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117-5532

Contacts

David Billmeier, Site 1023

386-278-8000

Integrity Clinical Research LLC - 21st Street

Recruiting

Doral, Florida, United States, 33122-1620

Contacts

Lucinda Cuervo-Ramos, Site 1164

305-888-0410

Betancourt Research Services

Recruiting

Doral, Florida, United States, 33172-2638

Contacts

Beatriz Triana, Site 1045

786-741-2287

Direct Helpers Research Center

Recruiting

Hialeah, Florida, United States, 33012-3618

Contacts

Manuel Fernandez, Site 1107

305-828-3555

New Life Medical Research Center -3750 W 16th Ave

Recruiting

Hialeah, Florida, United States, 33012-4648

Contacts

Jorge Betancourt, Site 1120

305-456-7782

Las Mercedes Medical Research - 4440 West 16th Ave

Recruiting

Hialeah, Florida, United States, 33012

Contacts

Frank Carlos Alvarez Li, Site 1052

786-334-6675

Galiz Research

Recruiting

Hialeah, Florida, United States, 33016-1814

Contacts

Jose Gamez, Site 1140

305-805-0921

Nexus Clinical Research Center- NRC

Recruiting

Homestead, Florida, United States, 33030

Coral Clinic Research

Recruiting

Homestead, Florida, United States, 33032

Contacts

Nelson Gonzalez, Site 1049

786-715-2200

Homestead Associates in Research Inc-30328 Old Dixie Hwy

Recruiting

Homestead, Florida, United States, 33033

Contacts

Angel Carrasco, Site 1159

786-422-7374

K2 Medical Research - Maitland

Recruiting

Maitland, Florida, United States, 32751-5669

Contacts

Brandon Lenox, Site 1039

407-670-5833

Premier Clinical Research Institute

Recruiting

Miami, Florida, United States, 33122-1335

Contacts

Emelina Arocha, Site 1021

305-445-5994

Angels Clinical Research Institute - Miami

Recruiting

Miami, Florida, United States, 33122-1721

Contacts

Yanely Pineiro Puebla, Site 1118

786-218-1733

CCM Clinical Research Group

Recruiting

Miami, Florida, United States, 33133-4231

Contacts

Francisco Ricart, Site 1108

208-346-8900

Wellness Research Center Inc - Miami

Recruiting

Miami, Florida, United States, 33135-1601

Contacts

Brian Villa, Site 1125

786-238-7099

A & D Doctor Center

Recruiting

Miami, Florida, United States, 33135-2968

Contacts

Yordan Orive Gomez, Site 1236

305-223-2000

Floridian Neuroscience Institute-1901 SW 1 St

Recruiting

Miami, Florida, United States, 33135

Contacts

Emilio Mantero-Atienza, Site 1115

305-326-0776

MedOne Clinical Research LLC

Recruiting

Miami, Florida, United States, 33145-2455

Contacts

Thierry Jacquemin, Site 1143

305-359-7666

Allied Biomedical Research Institute

Recruiting

Miami, Florida, United States, 33155-4630

Contacts

Michael Pfeffer, Site 1009

866-879-2507

My Community Research Center, Inc - 7480 Bird Rd

Recruiting

Miami, Florida, United States, 33155-6630

Contacts

Cesar Guerrero, Site 1113

786-359-4867

Future Care Solution LLC

Recruiting

Miami, Florida, United States, 33165-3947

Contacts

Pilar Trueba, Site 1129

305-888-0410

Reliant Medical Research

Recruiting

Miami, Florida, United States, 33165

Contacts

Carlos Ramirez Calderon, Site 1150

786-801-0912

South Florida Research Phase I-IV, Inc. - Miami

Recruiting

Miami, Florida, United States, 33166

Contacts

Silvia Silva Duluc, Site 1053

305-669-6166

Novel Clinical Research Center, LLC -7000 SW 97th Ave

Recruiting

Miami, Florida, United States, 33173-1474

Contacts

Heber Varela, Site 1006

000-000-0000

Dade Research Center - Miami FL - 7600 SW 87th Ave

Recruiting

Miami, Florida, United States, 33173

Contacts

Maria Nualart, Site 1111

305-263-7120

Florida Research Center, Inc.

Recruiting

Miami, Florida, United States, 33174-2950

Contacts

Sonia Rente, Site 1109

305-551-8493

Serenity Research Center

Recruiting

Miami, Florida, United States, 33176-1451

Contacts

Sergio Jaramillo, Site 1235

305-596-2080

IMIC LLC- 9380 SW 150th Str

Recruiting

Miami, Florida, United States, 33176-7947

Contacts

Leon Ramon, Site 1147

786-600-7005

New Gen Health

Recruiting

Miami, Florida, United States, 33176

Contacts

Roberto Hernando, Site 1234

305-892-1035

High Quality Research

Recruiting

Miami, Florida, United States, 33184-1412

Contacts

Jorge Gonzalez, Site 1157

305-392-0244

Coral Research Clinic & Coral Diagnostic Center

Recruiting

Miami, Florida, United States, 33186-4643

Contacts

Jorge Paoli Bruno, Site 1054

000-000-0000

ONHEALTH Research Center

Recruiting

Miami, Florida, United States, 33186-5882

Contacts

Maria Rodil, Site 1042

786-808-0832

New Med Research

Recruiting

Miami Gardens, Florida, United States, 33056-4000

Contacts

Marta Fernandez, Site 1126

305-269-7100

San Marcus Research Clinic Inc

Recruiting

Miami Lakes, Florida, United States, 33014-5602

Meridian International Research

Recruiting

Miami Lakes, Florida, United States, 33014-6435

Contacts

Gonzalo Quesada, Site 1102

305-705-4494

Ocean Blue Medical Research Center Inc

Recruiting

Miami Springs, Florida, United States, 33166-5260

Contacts

Antonio Terrelonge, Site 1026

305-885-8983

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

Neurology Associates of Ormond Beach

Recruiting

Ormond Beach, Florida, United States, 32174-3101

Contacts

David McDonald, Site 1204

386-673-2500

Angels Clinical Research Institute Tampa - Palm Springs - PPDS

Recruiting

Tampa, Florida, United States, 33614-2869

Contacts

Al Robaina, Site 1123

813-931-0128

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

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

Precise Research Centers

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Joseph Kwentus, Site 1132

601-420-5810

Five Towns Neurology PC -Woodmere - 923 Broadway

Recruiting

Woodmere, New York, United States, 11598-1739

Contacts

David Steiner, Site 1025

516-239-1800

AMC Research, LLC - Flourish - PPDS

Recruiting

Matthews, North Carolina, United States, 28105-8336

Contacts

Mohammad Bolouri, Site 1214

704-364-4000

Horizon Clinical Research: Gill Neuroscience

Recruiting

Cypress, Texas, United States, 77429-6070

Contacts

Harpaul Gill, Site 1106

949-491-0710

Clinical Trial Network - 7080 Southwest Fwy

Recruiting

Houston, Texas, United States, 77074-2085

Contacts

Djamchid Lotfi, Site 1004

713-484-6947

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-07-06.