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)
Psychosis Associated With Alzheimer's Disease
About this trial
This is an interventional treatment trial for Psychosis Associated With Alzheimer's Disease
Eligibility Criteria
Key Inclusion Criteria: Must have completed study KAR-031. Subject was aged 55 to 90 years, inclusive, at the time of enrollment into the parent KAR-031 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, provide assent and the subject's legally acceptable representative or study partner/caregiver, if local regulations allow, must provide informed consent 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). Key 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 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.
Sites / Locations
- Clinical Trial Site
- Clinical Trial Site
Arms of the Study
Arm 1
Experimental
KarXT
Xanomeline and Trospium Chloride Capsules