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RecruitingPhase 3

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT05980949

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1000
US sites recruiting
57
Study start
July 11, 2023
Record last updated
October 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: KarXT

Conditions: Psychosis Associated With Alzheimer's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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:
  • The subject's legally acceptable representative (LAR) must provide IC
  • 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.

Recruiting US locations

  • Advanced Research Center, Inc.

    Anaheim, CA 92805-5854

    Site contact: Steven Macina, Site 1104 · 714-999-6688

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

    Los Angeles, CA 90033-5313

    Site contact: Lon Schneider, Site 1226 · 323-442-3715

  • SC3 Research - Pasadena - 960 E. Green St

    Pasadena, CA 91106

    Site contact: M. Lorraine Purino, Site 1043 · 626-250-2070

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

    Walnut Creek, CA 94596

    Site contact: Ira Glick, Site 1007 · 925-298-5147

  • University of Connecticut Health Center

    Farmington, CT 06030

    Site contact: Neha Jain, Site 1222 · 860-790-7354

  • Envision Trials LLC

    Bonita Springs, FL 34134

    Site contact: Daniel Mandri, Site 1020 · 305-819-2909

  • K2 Medical Research - Winter Garden

    Clermont, FL 34711-5933

    Site contact: Christopher Galloway, Site 1048 · 321-500-5252

  • JY Research Institute Inc

    Cutler Bay, FL 33189-1230

    Site contact: Suez Oramas Mingo, Site 1138 · 305-424-8696

  • Arrow Clinical Trials

    Daytona Beach, FL 32117-5532

    Site contact: David Billmeier, Site 1023 · 386-278-8000

  • Integrity Clinical Research LLC - 21st Street

    Doral, FL 33122-1620

    Site contact: Lucinda Cuervo-Ramos, Site 1164 · 305-888-0410

  • Betancourt Research Services

    Doral, FL 33172-2638

    Site contact: Beatriz Triana, Site 1045 · 786-741-2287

  • Direct Helpers Research Center

    Hialeah, FL 33012-3618

    Site contact: Manuel Fernandez, Site 1107 · 305-828-3555

  • New Life Medical Research Center -3750 W 16th Ave

    Hialeah, FL 33012-4648

    Site contact: Jorge Betancourt, Site 1120 · 305-456-7782

  • Las Mercedes Medical Research - 4440 West 16th Ave

    Hialeah, FL 33012

    Site contact: Frank Carlos Alvarez Li, Site 1052 · 786-334-6675

  • Galiz Research

    Hialeah, FL 33016-1814

    Site contact: Jose Gamez, Site 1140 · 305-805-0921

  • Nexus Clinical Research Center- NRC

    Homestead, FL 33030

    Site contact: John Cintron, Site 1229

  • Coral Clinic Research

    Homestead, FL 33032

    Site contact: Nelson Gonzalez, Site 1049 · 786-715-2200

  • Homestead Associates in Research Inc-30328 Old Dixie Hwy

    Homestead, FL 33033

    Site contact: Angel Carrasco, Site 1159 · 786-422-7374

  • K2 Medical Research - Maitland

    Maitland, FL 32751-5669

    Site contact: Brandon Lenox, Site 1039 · 407-670-5833

  • Premier Clinical Research Institute

    Miami, FL 33122-1335

    Site contact: Emelina Arocha, Site 1021 · 305-445-5994

  • Angels Clinical Research Institute - Miami

    Miami, FL 33122-1721

    Site contact: Yanely Pineiro Puebla, Site 1118 · 786-218-1733

  • CCM Clinical Research Group

    Miami, FL 33133-4231

    Site contact: Francisco Ricart, Site 1108 · 208-346-8900

  • Wellness Research Center Inc - Miami

    Miami, FL 33135-1601

    Site contact: Brian Villa, Site 1125 · 786-238-7099

  • A & D Doctor Center

    Miami, FL 33135-2968

    Site contact: Yordan Orive Gomez, Site 1236 · 305-223-2000

  • Floridian Neuroscience Institute-1901 SW 1 St

    Miami, FL 33135

    Site contact: Emilio Mantero-Atienza, Site 1115 · 305-326-0776

  • MedOne Clinical Research LLC

    Miami, FL 33145-2455

    Site contact: Thierry Jacquemin, Site 1143 · 305-359-7666

  • Allied Biomedical Research Institute

    Miami, FL 33155-4630

    Site contact: Michael Pfeffer, Site 1009 · 866-879-2507

  • My Community Research Center, Inc - 7480 Bird Rd

    Miami, FL 33155-6630

    Site contact: Cesar Guerrero, Site 1113 · 786-359-4867

  • Future Care Solution LLC

    Miami, FL 33165-3947

    Site contact: Pilar Trueba, Site 1129 · 305-888-0410

  • Reliant Medical Research

    Miami, FL 33165

    Site contact: Carlos Ramirez Calderon, Site 1150 · 786-801-0912

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

    Miami, FL 33166

    Site contact: Silvia Silva Duluc, Site 1053 · 305-669-6166

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

    Miami, FL 33173-1474

    Site contact: Heber Varela, Site 1006 · 000-000-0000

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

    Miami, FL 33173

    Site contact: Maria Nualart, Site 1111 · 305-263-7120

  • Florida Research Center, Inc.

    Miami, FL 33174-2950

    Site contact: Sonia Rente, Site 1109 · 305-551-8493

  • Serenity Research Center

    Miami, FL 33176-1451

    Site contact: Sergio Jaramillo, Site 1235 · 305-596-2080

  • IMIC LLC- 9380 SW 150th Str

    Miami, FL 33176-7947

    Site contact: Leon Ramon, Site 1147 · 786-600-7005

  • New Gen Health

    Miami, FL 33176

    Site contact: Roberto Hernando, Site 1234 · 305-892-1035

  • High Quality Research

    Miami, FL 33184-1412

    Site contact: Jorge Gonzalez, Site 1157 · 305-392-0244

  • Coral Research Clinic & Coral Diagnostic Center

    Miami, FL 33186-4643

    Site contact: Jorge Paoli Bruno, Site 1054 · 000-000-0000

  • ONHEALTH Research Center

    Miami, FL 33186-5882

    Site contact: Maria Rodil, Site 1042 · 786-808-0832

  • New Med Research

    Miami Gardens, FL 33056-4000

    Site contact: Marta Fernandez, Site 1126 · 305-269-7100

  • San Marcus Research Clinic Inc

    Miami Lakes, FL 33014-5602

    Site contact: Nancy Navarro Gonzalez, Site 1032

  • Meridian International Research

    Miami Lakes, FL 33014-6435

    Site contact: Gonzalo Quesada, Site 1102 · 305-705-4494

  • Ocean Blue Medical Research Center Inc

    Miami Springs, FL 33166-5260

    Site contact: Antonio Terrelonge, Site 1026 · 305-885-8983

  • Nova Psychiatry

    Orlando, FL 32803

    Site contact: David Medina, Site 1242 · 407-823-8421

  • Combined Research Orlando Phase I-IV LLC

    Orlando, FL 32807-3555

    Site contact: Eric Carbonell, Site 1112 · 407-440-4493

  • Neurology Associates of Ormond Beach

    Ormond Beach, FL 32174-3101

    Site contact: David McDonald, Site 1204 · 386-673-2500

  • Angels Clinical Research Institute Tampa - Palm Springs - PPDS

    Tampa, FL 33614-2869

    Site contact: Al Robaina, Site 1123 · 813-931-0128

  • Guardian Angel Research

    Tampa, FL 33614

    Site contact: Sadaf Bazargan, Site 1124 · 813-300-3300

  • Interventional Psychiatry of Tampa Bay

    Tampa, FL 33629-5837

    Site contact: Jamie Fernandez, Site 1110 · 813-251-1800

  • Premiere Research Institute at Palm Beach Neurology, PA

    West Palm Beach, FL 33407-3209

    Site contact: Paul Winner, Site 1216 · 561-845-0500

  • Agile Clinical Research Trials, LLC

    Atlanta, GA 30328-5532

    Site contact: Vasundhara Cheekati, Site 1206 · 404-382-8660

  • Precise Research Centers

    Flowood, MS 39232

    Site contact: Joseph Kwentus, Site 1132 · 601-420-5810

  • Five Towns Neurology PC -Woodmere - 923 Broadway

    Woodmere, NY 11598-1739

    Site contact: David Steiner, Site 1025 · 516-239-1800

  • AMC Research, LLC - Flourish - PPDS

    Matthews, NC 28105-8336

    Site contact: Mohammad Bolouri, Site 1214 · 704-364-4000

  • Horizon Clinical Research: Gill Neuroscience

    Cypress, TX 77429-6070

    Site contact: Harpaul Gill, Site 1106 · 949-491-0710

  • Clinical Trial Network - 7080 Southwest Fwy

    Houston, TX 77074-2085

    Site contact: Djamchid Lotfi, Site 1004 · 713-484-6947

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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Open-Label Extension Study to Assess the Long-Term Safety and… (NCT05980949) | Bored Studies