Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT and KarXT + KarX-EC in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
- Conditions
- Psychosis Associated With Alzheimer's Disease
- Interventions
- Registration Number
- NCT05980949
- Lead Sponsor
- Karuna Therapeutics
- Brief Summary
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027, CN012-0056 or CN012-0034. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study, 14-week CN012-0056 or 14 week CN012-0034 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 and KarXT + KarX-EC in subjects with psychosis associated with Alzheimer's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Must have completed study CN012-0026, CN012-0027, CN012-0034 or CN012-0056.
- Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027, CN012-0034 or CN012-0056 study.
- Can understand the nature of the study and protocol requirements and provide a signed informed consent or, if deemed not competent to provide informed consent, the subject's legally acceptable representative must provide informed consent, and the subject must provide informed assent before any study assessments are performed.
- At entry into this study, or any time during the study, if a subject needs to relocate from home or residential assisted-living facility to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
- Have an identified or proxy caregiver (spends approximately 10 hours/week with the subject).
- 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 CN012-0026, CN012-0027, CN012-0034 or CN012-0056 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 CN012-0028.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description KarXT or KarXT + KarX-EC KarXT Xanomeline and Trospium Chloride Capsules KarXT or KarXT + KarX-EC KarX-EC Xanomeline and Trospium Chloride Capsules
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From initial dose through 14 days after the final dose (up to 54 weeks) The number and percentage of participants with TEAEs will be determined
- Secondary Outcome Measures
Name Time Method Incidence of serious TEAEs From initial dose through 14 days after the final dose (up to 54 weeks) The number and percentage of participants with serious TEAEs will be determined
Incidence of TEAEs leading to withdrawal From initial dose through 14 days after the final dose (up to 54 weeks) The number and percentage of participants with TEAEs leading to withdrawal will be determined
Trial Locations
- Locations (383)
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 - 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 - 1001
🇺🇸Costa Mesa, California, United States
Local Institution - 1151
🇺🇸Encino, California, United States
Scroll for more (373 remaining)Local Institution - 1029🇺🇸Homewood, Alabama, United States