NCT05980949From ClinicalTrials.govRecruiting

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)

Psychosis Associated With Alzheimer's Disease

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrolment target: 1,000
Started: 11 July 2023
Main results due: 7 September 2027
Study sites: 431
Registry updated: 29 September 2026

Can you take part?

Ages 55 years to 90 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(431)

Local Institution - 1029
Homewood, Alabama, United States
Withdrawn
Local Institution - 1-13H98LK9
Chandler, Arizona, United States
Withdrawn
Local Institution - 1227
Chandler, Arizona, United States
Withdrawn
Local Institution - 1116
Chandler, Arizona, United States
Withdrawn
Local Institution - 1247
Gilbert, Arizona, United States
Not yet recruiting
Local Institution - 1217
Phoenix, Arizona, United States
Not yet recruiting
Local Institution - 1044
Phoenix, Arizona, United States
Withdrawn
Local Institution - 1220
Scottsdale, Arizona, United States
Withdrawn
Advanced Research Center, Inc.
Anaheim, California, United States
Recruiting
Local Institution - 1-141NO1DG
Chino, California, United States
Not yet recruiting
Local Institution - 1001
Costa Mesa, California, United States
Withdrawn
Local Institution - 1151
Encino, California, United States
Withdrawn
Local Institution - 1033
Encino, California, United States
Withdrawn
Local Institution - 1031
Irvine, California, United States
Withdrawn
Local Institution - 1142
Lancaster, California, United States
Withdrawn
Local Institution - 1230
Long Beach, California, United States
Withdrawn
Local Institution - 1117
Los Alamitos, California, United States
Withdrawn
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California, United States
Recruiting
Local Institution - 1228
Orange, California, United States
Not yet recruiting
SC3 Research - Pasadena - 960 E. Green St
Pasadena, California, United States
Recruiting
Local Institution - 1213
Rancho Cucamonga, California, United States
Not yet recruiting
Local Institution - 1103
Sherman Oaks, California, United States
Completed
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California, United States
Recruiting
Local Institution - 1014
Colorado Springs, Colorado, United States
Withdrawn
University of Connecticut Health Center
Farmington, Connecticut, United States
Recruiting
Local Institution - 1013
Stamford, Connecticut, United States
Withdrawn
Local Institution - 1225
Atlantis, Florida, United States
Withdrawn
Local Institution - 1011
Boca Raton, Florida, United States
Withdrawn
Envision Trials LLC
Bonita Springs, Florida, United States
Recruiting
Local Institution - 1015
Bradenton, Florida, United States
Withdrawn
Local Institution - 1156
Clermont, Florida, United States
Withdrawn
K2 Medical Research - Winter Garden
Clermont, Florida, United States
Recruiting
JY Research Institute Inc
Cutler Bay, Florida, United States
Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, United States
Recruiting
Local Institution - 1224
Deerfield Beach, Florida, United States
Withdrawn
Local Institution - 1162
Delray Beach, Florida, United States
Withdrawn
Integrity Clinical Research LLC - 21st Street
Doral, Florida, United States
Recruiting
Betancourt Research Services
Doral, Florida, United States
Recruiting
Local Institution - 1165
Fort Myers, Florida, United States
Withdrawn
Local Institution - 1155
Hialeah, Florida, United States
Completed
Direct Helpers Research Center
Hialeah, Florida, United States
Recruiting
New Life Medical Research Center -3750 W 16th Ave
Hialeah, Florida, United States
Recruiting
Local Institution - 1046
Hialeah, Florida, United States
Not yet recruiting
Las Mercedes Medical Research - 4440 West 16th Ave
Hialeah, Florida, United States
Recruiting
Local Institution - 1-13JED81K
Hialeah, Florida, United States
Withdrawn
Local Institution - 1237
Hialeah, Florida, United States
Withdrawn
Galiz Research
Hialeah, Florida, United States
Recruiting
Nexus Clinical Research Center- NRC
Homestead, Florida, United States
Recruiting
Local Institution - 1145
Homestead, Florida, United States
Withdrawn
Coral Clinic Research
Homestead, Florida, United States
Recruiting
Homestead Associates in Research Inc-30328 Old Dixie Hwy
Homestead, Florida, United States
Recruiting
Local Institution - 1127
Largo, Florida, United States
Withdrawn
K2 Medical Research - Maitland
Maitland, Florida, United States
Recruiting
Local Institution - 1146
Maitland, Florida, United States
Withdrawn
Premier Clinical Research Institute
Miami, Florida, United States
Recruiting
Angels Clinical Research Institute - Miami
Miami, Florida, United States
Recruiting
Local Institution - 1005
Miami, Florida, United States
Not yet recruiting
CCM Clinical Research Group
Miami, Florida, United States
Recruiting
Wellness Research Center Inc - Miami
Miami, Florida, United States
Recruiting
A & D Doctor Center
Miami, Florida, United States
Recruiting

Showing 60 of 431 sites — filter to narrow it down. 131 of the 431 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05980949. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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