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RECRUITING

NCT05980949

PHASE3

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)

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2023-07-11

Completion Date

2027-09-07

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Psychosis Associated With Alzheimer's Disease

Interventions

DRUG

KarXT

KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

Locations (432)

Local Institution - 1029

Homewood, Alabama, United States

Local Institution - 1-13H98LK9

Chandler, Arizona, United States

Local Institution - 1227

Chandler, Arizona, United States

Local Institution - 1116

Chandler, Arizona, United States

Local Institution - 1247

Gilbert, Arizona, United States

Local Institution - 1217

Phoenix, Arizona, United States

Local Institution - 1044

Phoenix, Arizona, United States

Local Institution - 1220

Scottsdale, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Local Institution - 1-141NO1DG

Chino, California, United States

Local Institution - 1244

Chino, California, United States

Local Institution - 1001

Costa Mesa, California, United States

Local Institution - 1151

Encino, California, United States

Local Institution - 1033

Encino, California, United States

Local Institution - 1031

Irvine, California, United States

Local Institution - 1142

Lancaster, California, United States

Local Institution - 1230

Long Beach, California, United States

Local Institution - 1117

Los Alamitos, California, United States

USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)

Los Angeles, California, United States

Local Institution - 1228

Orange, California, United States

SC3 Research - Pasadena - 960 E. Green St

Pasadena, California, United States

Local Institution - 1213

Rancho Cucamonga, California, United States

Local Institution - 1103

Sherman Oaks, California, United States

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

Walnut Creek, California, United States

Local Institution - 1014

Colorado Springs, Colorado, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

Local Institution - 1013

Stamford, Connecticut, United States

Local Institution - 1225

Atlantis, Florida, United States

Local Institution - 1011

Boca Raton, Florida, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Local Institution - 1015

Bradenton, Florida, United States

Local Institution - 1156

Clermont, Florida, United States

K2 Medical Research - Winter Garden

Clermont, Florida, United States

JY Research Institute Inc

Cutler Bay, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

Local Institution - 1224

Deerfield Beach, Florida, United States

Local Institution - 1162

Delray Beach, Florida, United States

Integrity Clinical Research LLC - 21st Street

Doral, Florida, United States

Betancourt Research Services

Doral, Florida, United States

Local Institution - 1165

Fort Myers, Florida, United States

Local Institution - 1155