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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

NCT ID: NCT06585787
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions: Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

Enrollment: 406 participants (Estimated).

What is being studied

Drug: KarXT
Drug: Placebo

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 * Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup. * Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. * Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation). Exclusion Criteria \- Patients will not be able to participate if they have: i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities. \* Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations

295 study locations are listed.

Recruiting site status is explicitly provided for 295 locations; 161 are listed as Recruiting.

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

Buenos Aires, Argentina: 3
Santa Fe Province, Argentina: 1
Brussels Capital, Belgium: 1
West-Vlaanderen, Belgium: 1
Federal District, Brazil: 1
São Paulo, Brazil: 4
Sofia-Grad, Bulgaria: 1
Beijing Municipality, China: 3
Chongqing Municipality, China: 1
Guangdong, China: 3
Jiangsu, China: 3
Shan1xi, China: 1
Shanghai Municipality, China: 3
Sichuan, China: 1
Tianjin Municipality, China: 1
Zhejiang, China: 4
City of Zagreb, Croatia: 5
Alpes-Maritimes, France: 1
Indre-et-Loire, France: 1
Baden-Wurttemberg, Germany: 1
Saarland, Germany: 1
Attica, Greece: 3
Irakleio, Greece: 1
Baranya, Hungary: 1
Csongrád megye, Hungary: 1
Heves County, Hungary: 1
Maharashtra, India: 2
Punjab, India: 1
Rajasthan, India: 1
Jerusalem, Israel: 1

Sample of listed locations

Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L. — Ciudad Autónoma de Buenos Aires, Buenos Aires, C1058AAJ, Argentina — Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215 — Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056, Argentina — Recruiting
Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM — Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107, Argentina — Recruiting
Instituto Médico de la Fundación Estudios Clínicos — Rosario, Santa Fe Province, S2000DEJ, Argentina — Recruiting
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI — Buenos Aires, C1428AQK, Argentina — Recruiting
Hospital Italiano de Buenos Aires — Buenos Aires, 1199, Argentina — Recruiting
Organización Médica de Investigación — Buenos Aires, C1015ABO, Argentina — Recruiting
Centro Especializado en Neurociencias - CEN — Córdoba, 5000, Argentina — Recruiting
Instituto Privado Kremer — Córdoba, 5004, Argentina — Recruiting
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME — Brasília, Federal District, 70200-730, Brazil — Recruiting
BR Trials - Pesquisa Clínica — São Paulo, São Paulo, 01236-030, Brazil — Recruiting
Clinilive — São Paulo, São Paulo, 87013-250, Brazil — Recruiting
CPQuali Pesquisa Clínica Sao Paulo — São Paulo, São Paulo, 01228-000, Brazil — Recruiting
Hospital Alemao Oswaldo Cruz (HAOC) — São Paulo, São Paulo, 01327-001, Brazil — Recruiting
Ruschel Medicina — Rio de Janeiro, 22270060, Brazil — Recruiting
Instituto de Psiquiatria HC FMUSP — São Paulo, 05403-010, Brazil — 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 Medika 2005 - Branch Sofia — Sofia, 1164, Bulgaria — Recruiting
Beijing Anding Hospital Capital Medical University — Beijing, Beijing Municipality, 100088, China — Recruiting
Beijing Hospital — Beijing, Beijing Municipality, 100730, China — Recruiting
China-Japan Friendship Hospital — Beijing, Beijing Municipality, 100025, China — Recruiting
The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, 400016, China — Recruiting
Guangdong Provincial People's Hospital — Guangzhou, Guangdong, 510120, China — Recruiting
Shenzhen Kangning Hospital — Shenzhen, Guangdong, 518118, China — Recruiting

Study details

Start date: September 26, 2024
Primary completion date: November 24, 2026
Completion date: December 22, 2026
First posted: September 19, 2024

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06585787
Registry last updated: September 22, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06585787 on ClinicalTrials.gov

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

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