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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

RecruitingPhase 3

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Conditions: Psychosis Associated With Alzheimer's Disease

Interventions: KarXT

Countries: United States, Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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:

1. The subject's legally acceptable representative (LAR) must provide IC
2. 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.

Locations (429)

Homewood, Alabama, United States
Chandler, Arizona, United States
Chandler, Arizona, United States
Chandler, Arizona, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Anaheim, California, United States
Chino, California, United States
Costa Mesa, California, United States
Encino, California, United States
Encino, California, United States
Irvine, California, United States
Lancaster, California, United States
Long Beach, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Orange, California, United States
Pasadena, California, United States
Rancho Cucamonga, California, United States
Sherman Oaks, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Farmington, Connecticut, United States
Stamford, Connecticut, United States
Atlantis, Florida, United States
Boca Raton, Florida, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
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