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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)

NCT ID: NCT05980949
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions: Psychosis Associated With Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 1000 participants (Estimated).

What is being studied

Drug: KarXT

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

431 study locations are listed.

Recruiting site status is explicitly provided for 431 locations; 131 are listed as Recruiting.

Countries: Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Puerto Rico, Romania, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States

Buenos Aires, Argentina: 4
Santa Fe Province, Argentina: 1
Brussels Capital, Belgium: 1
Limburg, Belgium: 1
Vlaams Brabant, Belgium: 1
West-Vlaanderen, Belgium: 1
Federal District, Brazil: 2
São Paulo, Brazil: 8
Sofia-Grad, Bulgaria: 3
Alberta, Canada: 1
Ontario, Canada: 2
Quebec, Canada: 2
Santiago Metropolitan, Chile: 1
Anhui, China: 1
Beijing Municipality, China: 3
Chongqing Municipality, China: 1
Guangdong, China: 4
Jiangsu, China: 4
Jiangxi, China: 1
Shan1xi, China: 1
Shanghai Municipality, China: 4
Sichuan, China: 1
Tianjin Municipality, China: 1
Zhejiang, China: 7
City of Zagreb, Croatia: 7
Praha, Hlavní Mesto, Czechia: 1
Alpes-Maritimes, France: 1
Indre-et-Loire, France: 1
Marne, France: 1
Seine-Maritime, France: 1

Sample of listed locations

BR Trials - Pesquisa Clínica — São Paulo, São Paulo, 01236-030, Brazil — Recruiting
CPQuali Pesquisa Clínica Sao Paulo — São Paulo, São Paulo, 01228-000, Brazil — Recruiting
Ruschel Medicina — Rio de Janeiro, 22270060, Brazil — Recruiting
Instituto de Psiquiatria HC FMUSP — São Paulo, 05403-010, Brazil — Recruiting
Medical Center Medconsult Pleven OOD — Pleven, 5800, Bulgaria — Recruiting
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd — Plovdiv, 4001, Bulgaria — Recruiting
University Multiprofile Hospital For Active Treatment Kanev AD — Rousse, 7002, Bulgaria — Recruiting
Medical Center Sveti Naum EOOD — Sofia, 1113, Bulgaria — Recruiting
Biomedica Research Group — Providencia, Santiago Metropolitan, 7500000, Chile — Recruiting
Psicomed Estudios Medicos — Antofagasta, 1270244, Chile — Recruiting
Especialidades Medicas L Y S — Las Condes, 7550000, Chile — Recruiting
Beijing Anding Hospital Capital Medical University — Beijing, Beijing Municipality, 100088, China — Recruiting
Guangdong Provincial People's Hospital — Guangzhou, Guangdong, 510120, China — Recruiting
The Affiliated Brain Hospital of Guangzhou Medical University — Guangzhou, Guangdong, 0, China — Recruiting
Shenzhen Kangning Hospital — Shenzhen, Guangdong, 518118, China — Recruiting
The Second Affiliated Hospital of Nanjing Medical University - Main Campus — Nanjing, Jiangsu, 210011, China — Recruiting
Shanghai Mental Health Center - PPDS — Shanghai, Shanghai Municipality, 200030, China — Recruiting
Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, 200065, China — Recruiting
West China Hospital Sichuan University — Chengdu, Sichuan, 610000, China — Recruiting
Tianjin Anding Hospital(Tianjin mental Health Center) — Tianjin, Tianjin Municipality, 300222, China — Recruiting
People's Hospital of Zhejiang Province — Hangzhou, Zhejiang, 310014, China — Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus — Hangzhou, Zhejiang, 310016, China — Recruiting
Klinicki Bolnicki Centar Zagreb — Zagreb, City of Zagreb, 10000, Croatia — Recruiting
Klinika za psihijatriju Vrapce — Zagreb, City of Zagreb, 10090, Croatia — Recruiting
CLINTRIAL s.r.o. — Prague, Praha, Hlavní Mesto, 100 00, Czechia — Recruiting

Study details

Start date: July 11, 2023
Primary completion date: September 7, 2027
Completion date: September 7, 2027
First posted: August 8, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05980949
Registry last updated: September 29, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT05980949 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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