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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)

RecruitingPhase 3

Who can join

Ages 55 to 90 · All sexes

Full eligibility 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:

  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.

About the study

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.

What is being tested

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 1,000 · Started: Jul 11, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05980949

Locations in the U.S.

ArizonaLocal Institution - 1247, Gilbert (Not yet recruiting)
Local Institution - 1217, Phoenix (Not yet recruiting)
CaliforniaAdvanced Research Center, Inc., Anaheim
Local Institution - 1-141NO1DG, Chino (Not yet recruiting)
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC), Los Angeles
Local Institution - 1228, Orange (Not yet recruiting)
SC3 Research - Pasadena - 960 E. Green St, Pasadena
Local Institution - 1213, Rancho Cucamonga (Not yet recruiting)
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS, Walnut Creek
ConnecticutUniversity of Connecticut Health Center, Farmington
FloridaEnvision Trials LLC, Bonita Springs
K2 Medical Research - Winter Garden, Clermont
JY Research Institute Inc, Cutler Bay
Arrow Clinical Trials, Daytona Beach
Betancourt Research Services, Doral
Integrity Clinical Research LLC - 21st Street, Doral
Direct Helpers Research Center, Hialeah
Galiz Research, Hialeah
Las Mercedes Medical Research - 4440 West 16th Ave, Hialeah
Local Institution - 1046, Hialeah (Not yet recruiting)
New Life Medical Research Center -3750 W 16th Ave, Hialeah
Coral Clinic Research, Homestead
Homestead Associates in Research Inc-30328 Old Dixie Hwy, Homestead
Nexus Clinical Research Center- NRC, Homestead
K2 Medical Research - Maitland, Maitland
A & D Doctor Center, Miami
Allied Biomedical Research Institute, Miami
Angels Clinical Research Institute - Miami, Miami
CCM Clinical Research Group, Miami
Coral Research Clinic & Coral Diagnostic Center, Miami
Dade Research Center - Miami FL - 7600 SW 87th Ave, Miami
Florida Research Center, Inc., Miami
Floridian Neuroscience Institute-1901 SW 1 St, Miami
Future Care Solution LLC, Miami
High Quality Research, Miami
IMIC LLC- 9380 SW 150th Str, Miami
Local Institution - 1005, Miami (Not yet recruiting)
MedOne Clinical Research LLC, Miami
My Community Research Center, Inc - 7480 Bird Rd, Miami
New Gen Health, Miami
Novel Clinical Research Center, LLC -7000 SW 97th Ave, Miami
ONHEALTH Research Center, Miami
Premier Clinical Research Institute, Miami
Reliant Medical Research, Miami
Serenity Research Center, Miami
South Florida Research Phase I-IV, Inc. - Miami, Miami
Wellness Research Center Inc - Miami, Miami
New Med Research, Miami Gardens
Meridian International Research, Miami Lakes
San Marcus Research Clinic Inc, Miami Lakes
Ocean Blue Medical Research Center Inc, Miami Springs
Local Institution - 1246, Naples (Not yet recruiting)
Local Institution - 1212, Ocoee (Not yet recruiting)
Combined Research Orlando Phase I-IV LLC, Orlando
Nova Psychiatry, Orlando
Neurology Associates of Ormond Beach, Ormond Beach
Angels Clinical Research Institute Tampa - Palm Springs - PPDS, Tampa
Guardian Angel Research, Tampa
Interventional Psychiatry of Tampa Bay, Tampa
Local Institution - 1041, Tampa (Not yet recruiting)
Premiere Research Institute at Palm Beach Neurology, PA, West Palm Beach
GeorgiaAgile Clinical Research Trials, LLC, Atlanta
MassachusettsLocal Institution - 1223, Belmont (Not yet recruiting)
Local Institution - 1245, Boston (Not yet recruiting)
Local Institution - 1243, North Dartmouth (Not yet recruiting)
Local Institution - 1239, Springfield (Not yet recruiting)
MichiganLocal Institution - 1248, Bloomfield Township (Not yet recruiting)
MississippiPrecise Research Centers, Flowood
MissouriLocal Institution - 1255, St Louis (Not yet recruiting)
New JerseyLocal Institution - 1202, Toms River (Not yet recruiting)
New YorkLocal Institution - 1240, Syracuse (Not yet recruiting)
Five Towns Neurology PC -Woodmere - 923 Broadway, Woodmere
North CarolinaLocal Institution - 1221, Greensboro (Not yet recruiting)
AMC Research, LLC - Flourish - PPDS, Matthews
Local Institution - 1215, Morehead City (Not yet recruiting)
Local Institution - 1252, Shelby (Not yet recruiting)
OhioLocal Institution - 1201, Columbus (Not yet recruiting)
Local Institution - 1249, Shaker Heights (Not yet recruiting)
OklahomaLocal Institution - 1016, Oklahoma City (Not yet recruiting)
TexasHorizon Clinical Research: Gill Neuroscience, Cypress
Local Institution - 1121, DeSoto (Not yet recruiting)
Local Institution - 1208, El Paso (Not yet recruiting)
Clinical Trial Network - 7080 Southwest Fwy, Houston
Local Institution - 1210, San Antonio (Not yet recruiting)
VirginiaLocal Institution - 1241, Arlington (Not yet recruiting)
WashingtonLocal Institution - 1254, Kirkland (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.