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)
NCT05980949
This study is recruiting at 57 US sites in 8 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Psychosis Associated With Alzheimer's Disease
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Last updated on ClinicalTrials.gov
- September 29, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 4
- Advanced Research Center, Inc. · Anaheim, CA
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) · Los Angeles, CA
- SC3 Research - Pasadena - 960 E. Green St · Pasadena, CA
- Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS · Walnut Creek, CA
Connecticut · 1
- University of Connecticut Health Center · Farmington, CT
Florida · 46
- Envision Trials LLC · Bonita Springs, FL
- K2 Medical Research - Winter Garden · Clermont, FL
- JY Research Institute Inc · Cutler Bay, FL
- Arrow Clinical Trials · Daytona Beach, FL
- Betancourt Research Services · Doral, FL
- Integrity Clinical Research LLC - 21st Street · Doral, FL
- Direct Helpers Research Center · Hialeah, FL
- Galiz Research · Hialeah, FL
- Las Mercedes Medical Research - 4440 West 16th Ave · Hialeah, FL
- New Life Medical Research Center -3750 W 16th Ave · Hialeah, FL
- Coral Clinic Research · Homestead, FL
- Homestead Associates in Research Inc-30328 Old Dixie Hwy · Homestead, FL
- Nexus Clinical Research Center- NRC · Homestead, FL
- K2 Medical Research - Maitland · Maitland, FL
- A & D Doctor Center · Miami, FL
- Allied Biomedical Research Institute · Miami, FL
- Angels Clinical Research Institute - Miami · Miami, FL
- CCM Clinical Research Group · Miami, FL
- Coral Research Clinic & Coral Diagnostic Center · Miami, FL
- Dade Research Center - Miami FL - 7600 SW 87th Ave · Miami, FL
- Florida Research Center, Inc. · Miami, FL
- Floridian Neuroscience Institute-1901 SW 1 St · Miami, FL
- Future Care Solution LLC · Miami, FL
- High Quality Research · Miami, FL
- IMIC LLC- 9380 SW 150th Str · Miami, FL
- MedOne Clinical Research LLC · Miami, FL
- My Community Research Center, Inc - 7480 Bird Rd · Miami, FL
- New Gen Health · Miami, FL
- Novel Clinical Research Center, LLC -7000 SW 97th Ave · Miami, FL
- ONHEALTH Research Center · Miami, FL
- Premier Clinical Research Institute · Miami, FL
- Reliant Medical Research · Miami, FL
- Serenity Research Center · Miami, FL
- South Florida Research Phase I-IV, Inc. - Miami · Miami, FL
- Wellness Research Center Inc - Miami · Miami, FL
- New Med Research · Miami Gardens, FL
- Meridian International Research · Miami Lakes, FL
- San Marcus Research Clinic Inc · Miami Lakes, FL
- Ocean Blue Medical Research Center Inc · Miami Springs, FL
- Combined Research Orlando Phase I-IV LLC · Orlando, FL
- Nova Psychiatry · Orlando, FL
- Neurology Associates of Ormond Beach · Ormond Beach, FL
- Angels Clinical Research Institute Tampa - Palm Springs - PPDS · Tampa, FL
- Guardian Angel Research · Tampa, FL
- Interventional Psychiatry of Tampa Bay · Tampa, FL
- Premiere Research Institute at Palm Beach Neurology, PA · West Palm Beach, FL
Georgia · 1
- Agile Clinical Research Trials, LLC · Atlanta, GA
Mississippi · 1
- Precise Research Centers · Flowood, MS
New York · 1
- Five Towns Neurology PC -Woodmere - 923 Broadway · Woodmere, NY
North Carolina · 1
- AMC Research, LLC - Flourish - PPDS · Matthews, NC
Texas · 2
- Horizon Clinical Research: Gill Neuroscience · Cypress, TX
- Clinical Trial Network - 7080 Southwest Fwy · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.