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Clinical Trials in the USA / NCT05980949
Recruiting Phase 3

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 · tracked via the Priya Life Science USA tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 3
Started
2023-07-11
Last updated
2026-07-06

Condition(s) studied

Psychosis Associated With Alzheimer's Disease

Investigational drug(s) / intervention(s)

KarXT

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)

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (429)

FacilityCityRegionStatus
Local Institution - 1029 Homewood Alabama Withdrawn
Local Institution - 1-13H98LK9 Chandler Arizona Withdrawn
Local Institution - 1227 Chandler Arizona Withdrawn
Local Institution - 1116 Chandler Arizona Withdrawn
Local Institution - 1247 Gilbert Arizona Not Yet Recruiting
Local Institution - 1217 Phoenix Arizona Not Yet Recruiting
Local Institution - 1044 Phoenix Arizona Withdrawn
Local Institution - 1220 Scottsdale Arizona Withdrawn
Advanced Research Center, Inc. Anaheim California Recruiting
Local Institution - 1-141NO1DG Chino California Not Yet Recruiting
Local Institution - 1001 Costa Mesa California Withdrawn
Local Institution - 1151 Encino California Withdrawn
Local Institution - 1033 Encino California Withdrawn
Local Institution - 1031 Irvine California Withdrawn
Local Institution - 1142 Lancaster California Withdrawn
Local Institution - 1230 Long Beach California Withdrawn
Local Institution - 1117 Los Alamitos California Withdrawn
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) Los Angeles California Recruiting
Local Institution - 1228 Orange California Not Yet Recruiting
SC3 Research - Pasadena - 960 E. Green St Pasadena California Recruiting
Local Institution - 1213 Rancho Cucamonga California Not Yet Recruiting
Local Institution - 1103 Sherman Oaks California Completed
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS Walnut Creek California Recruiting
Local Institution - 1014 Colorado Springs Colorado Withdrawn
University of Connecticut Health Center Farmington Connecticut Recruiting
Local Institution - 1013 Stamford Connecticut Withdrawn
Local Institution - 1225 Atlantis Florida Withdrawn
Local Institution - 1011 Boca Raton Florida Withdrawn
Envision Trials LLC Bonita Springs Florida Recruiting
Local Institution - 1015 Bradenton Florida Withdrawn
Local Institution - 1156 Clermont Florida Withdrawn
K2 Medical Research - Winter Garden Clermont Florida Recruiting
JY Research Institute Inc Cutler Bay Florida Recruiting
Arrow Clinical Trials Daytona Beach Florida Recruiting
Local Institution - 1224 Deerfield Beach Florida Withdrawn
Local Institution - 1162 Delray Beach Florida Withdrawn
Integrity Clinical Research LLC - 21st Street Doral Florida Recruiting
Betancourt Research Services Doral Florida Recruiting
Local Institution - 1165 Fort Myers Florida Withdrawn
Local Institution - 1155 Hialeah Florida Completed

+ 389 more sites — see the full list on the official registry below.

More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05980949 on ClinicalTrials.gov ↗ ← All trials in the USA