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)
Recruiting now · Phase 3
Conditions studied: Psychosis Associated With Alzheimer's Disease
In brief
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.
Key facts
- Study ID
- NCT05980949
- Run by
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- People needed
- 1000
- Starts
- 2023-07-11
- Expected to finish
- 2027-09-07
- Last updated by the study team
- 2026-07-06
Who can join
Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Nexus Clinical Research Center- NRC — Homestead, Florida, United States (enrolling)
- A & D Doctor Center — Miami, Florida, United States (enrolling)
- Integrity Clinical Research LLC - 21st Street — Doral, Florida, United States (enrolling)
- Galiz Research — Hialeah, Florida, United States (enrolling)
- Premier Clinical Research Institute — Miami, Florida, United States (enrolling)
- Wellness Research Center Inc - Miami — Miami, Florida, United States (enrolling)
- JY Research Institute Inc — Cutler Bay, Florida, United States (enrolling)
- Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
- Direct Helpers Research Center — Hialeah, Florida, United States (enrolling)
- Las Mercedes Medical Research - 4440 West 16th Ave — Hialeah, Florida, United States (enrolling)
- Homestead Associates in Research Inc-30328 Old Dixie Hwy — Homestead, Florida, United States (enrolling)
- K2 Medical Research - Maitland — Maitland, Florida, United States (enrolling)
- Angels Clinical Research Institute - Miami — Miami, Florida, United States (enrolling)
- CCM Clinical Research Group — Miami, Florida, United States (enrolling)
- Envision Trials LLC — Bonita Springs, Florida, United States (enrolling)
- K2 Medical Research - Winter Garden — Clermont, Florida, United States (enrolling)
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) — Los Angeles, California, United States (enrolling)
- Advanced Research Center, Inc. — Anaheim, California, United States (enrolling)
- SC3 Research - Pasadena - 960 E. Green St — Pasadena, California, United States (enrolling)
- Betancourt Research Services — Doral, Florida, United States (enrolling)
- New Life Medical Research Center -3750 W 16th Ave — Hialeah, Florida, United States (enrolling)
- Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS — Walnut Creek, California, United States (enrolling)
- Coral Clinic Research — Homestead, Florida, United States (enrolling)
- University of Connecticut Health Center — Farmington, Connecticut, United States (enrolling)
- Floridian Neuroscience Institute-1901 SW 1 St — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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