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)

Karuna Therapeutics, Inc., a Bristol Myers Squibb company839 sites in 1 country800 target enrollmentJuly 11, 2023

ConditionsPsychosis Associated With Alzheimer's Disease

InterventionsKarXT

DrugsKarXT KarX-EC

Overview

Phase: Phase 3
Intervention: KarXT
Conditions: Psychosis Associated With Alzheimer's Disease
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrollment: 800
Locations: 839
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs)
Status: Recruiting
Last Updated: 11 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 11, 2023

End Date

September 7, 2027

Last Updated

11 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have completed study CN012-0026, CN012-0027 or CN012-
•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-
•Other protocol-defined Inclusion/Exclusion criteria apply.

Arms & Interventions

KarXT

Xanomeline and Trospium Chloride Capsules

Intervention: KarXT

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame: From initial dose through 14 days after the final dose (up to 54 weeks)

The number and percentage of participants with TEAEs will be determined

Secondary Outcomes

Incidence of serious TEAEs(From initial dose through 14 days after the final dose (up to 54 weeks))
Incidence of TEAEs leading to withdrawal(From initial dose through 14 days after the final dose (up to 54 weeks))