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 · NCT05980949 · Interventional (participants receive a specific treatment) · Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
55 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 24 US states.
- Local Institution - 1029 - Homewood, Alabama, United States
- Local Institution - 1-13H98LK9 - Chandler, Arizona, United States
- Local Institution - 1227 - Chandler, Arizona, United States
- Local Institution - 1116 - Chandler, Arizona, United States
- Local Institution - 1247 - Gilbert, Arizona, United States
- Local Institution - 1217 - Phoenix, Arizona, United States
- Local Institution - 1044 - Phoenix, Arizona, United States
- Local Institution - 1220 - Scottsdale, Arizona, United States
- Advanced Research Center, Inc. - Anaheim, California, United States
- Local Institution - 1-141NO1DG - Chino, California, United States
- Local Institution - 1001 - Costa Mesa, California, United States
- Local Institution - 1151 - Encino, California, United States
- Local Institution - 1033 - Encino, California, United States
- Local Institution - 1031 - Irvine, California, United States
- Local Institution - 1142 - Lancaster, California, United States
- Local Institution - 1230 - Long Beach, California, United States
- Local Institution - 1117 - Los Alamitos, California, United States
- USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) - Los Angeles, California, United States
- Local Institution - 1228 - Orange, California, United States
- SC3 Research - Pasadena - 960 E. Green St - Pasadena, California, United States
- Local Institution - 1213 - Rancho Cucamonga, California, United States
- Local Institution - 1103 - Sherman Oaks, California, United States
- Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS - Walnut Creek, California, United States
- Local Institution - 1014 - Colorado Springs, Colorado, United States
- University of Connecticut Health Center - Farmington, Connecticut, United States
- Local Institution - 1013 - Stamford, Connecticut, United States
- Local Institution - 1225 - Atlantis, Florida, United States
- Local Institution - 1011 - Boca Raton, Florida, United States
- Envision Trials LLC - Bonita Springs, Florida, United States
- Local Institution - 1015 - Bradenton, Florida, United States
- Local Institution - 1156 - Clermont, Florida, United States
- K2 Medical Research - Winter Garden - Clermont, Florida, United States
- JY Research Institute Inc - Cutler Bay, Florida, United States
- Arrow Clinical Trials - Daytona Beach, Florida, United States
- Local Institution - 1224 - Deerfield Beach, Florida, United States
- Local Institution - 1162 - Delray Beach, Florida, United States
- Integrity Clinical Research LLC - 21st Street - Doral, Florida, United States
- Betancourt Research Services - Doral, Florida, United States
- Local Institution - 1165 - Fort Myers, Florida, United States
- Local Institution - 1155 - Hialeah, Florida, United States
- Direct Helpers Research Center - Hialeah, Florida, United States
- New Life Medical Research Center -3750 W 16th Ave - Hialeah, Florida, United States
- Local Institution - 1046 - Hialeah, Florida, United States
- Las Mercedes Medical Research - 4440 West 16th Ave - Hialeah, Florida, United States
- Local Institution - 1-13JED81K - Hialeah, Florida, United States
- Local Institution - 1237 - Hialeah, Florida, United States
- Galiz Research - Hialeah, Florida, United States
- Nexus Clinical Research Center- NRC - Homestead, Florida, United States
- Local Institution - 1145 - Homestead, Florida, United States
- Coral Clinic Research - Homestead, Florida, United States
- Homestead Associates in Research Inc-30328 Old Dixie Hwy - Homestead, Florida, United States
- Local Institution - 1127 - Largo, Florida, United States
- K2 Medical Research - Maitland - Maitland, Florida, United States
- Local Institution - 1146 - Maitland, Florida, United States
- Premier Clinical Research Institute - Miami, Florida, United States
- Angels Clinical Research Institute - Miami - Miami, Florida, United States
- Local Institution - 1005 - Miami, Florida, United States
- CCM Clinical Research Group - Miami, Florida, United States
- Wellness Research Center Inc - Miami - Miami, Florida, United States
- A & D Doctor Center - Miami, Florida, United States
Showing 60 of 429 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →