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)

Description

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.

Conditions

Psychosis Associated With Alzheimer's Disease

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Study Overview

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Study Details

Study overview

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.

A Phase 3 Global, Multicenter, Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease

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)

Condition
Psychosis Associated With Alzheimer's Disease
Intervention / Treatment

-

Contacts and Locations

Homewood

Local Institution - 1029, Homewood, Alabama, United States, 35209-6809

Chandler

Local Institution - 1-13H98LK9, Chandler, Arizona, United States, 85224-6231

Chandler

Local Institution - 1116, Chandler, Arizona, United States, 85286

Phoenix

Local Institution - 1217, Phoenix, Arizona, United States, 85006-2528

Phoenix

Local Institution - 1044, Phoenix, Arizona, United States, 85012-2836

Anaheim

Advanced Research Center, Inc., Anaheim, California, United States, 92805-5854

Costa Mesa

Local Institution - 1001, Costa Mesa, California, United States, 92626

Encino

Local Institution - 1151, Encino, California, United States, 91316

Encino

Local Institution - 1033, Encino, California, United States, 91436-2201

Irvine

Local Institution - 1031, Irvine, California, United States, 92612-1246

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

55 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Karuna Therapeutics,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2027-09-07