RECRUITINGPhase 3INTERVENTIONAL
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)
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- Must have completed study CN012-0026, CN012-0027 or CN012-0056.
- Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 or CN012-0056 study.
- Can understand the nature of the study and protocol requirements and provide a signed willing to sign a consent form or, if deemed not competent to provide willing to sign a consent form, the subject's legally acceptable representative must provide willing to sign a consent form, 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).
Who Should NOT Join This Trial:
- 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 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Must have completed study CN012-0026, CN012-0027 or CN012-0056.
* Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent CN012-0026, CN012-0027 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).
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 CN012-0026, CN012-0027 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.
Treatments Being Tested
DRUG
KarXT
KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
Locations (20)
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 - 1230
Lakewood, California, United States
Local Institution - 1142
Lancaster, 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