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)

Karuna Therapeutics

Status and phase

Enrolling

Phase 3

Conditions

Psychosis Associated With Alzheimer's Disease

Treatments

Drug: KarXT

Drug: KarX-EC

Study type

Interventional

Funder types

Industry

Identifiers

NCT05980949

KAR-033

2023-504151-27 (Other Identifier)

CN012-0028

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

55 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

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, 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.