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

406 patients around the world

Available in Argentina, Puerto Rico, Brazil

Karuna Therapeutics

20Research sites

406Patients around the world

This study is for people with

Alzheimer disease

Requirements for the patient

To 90 Years

All Gender

Medical requirements

: Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
Patients who are diagnosed with possible AD or probable AD.
Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain 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.
Patient must have a history of psychotic symptoms for at least 2 months prior to Screening (Visit 1).
Other protocol-defined criteria apply.

: Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
Other protocol-defined criteria apply.

Sites

Instituto Médico de la Fundación Estudios Clínicos - Rosario

Recruiting

Italia 428, Rosario - Santa Fe

Organización Médica de Investigación (OMI)

Recruiting

Uruguay 725 PB , Buenos Aires, CP: 1015

CENYDET Centro Neurobiológico y de Estrés Traumático (Biopsychomedical Research Group S.R.L.)

Recruiting

Marcelo T de Alvear 768 - 4° "A" CABA - Ciudad Autónoma de Bs As 1058AAJ

Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires

Recruiting

Viamonte 2213, C1056ABI Cdad. Autónoma de Buenos Aires, Argentina

Instituto Privado Kremer

Recruiting

Coronel Pringles 73, Córdoba

Hospital Italiano de Buenos Aires - CABA, Buenos Aires

Recruiting

Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH

Fleni - sede Belgrano

Recruiting

Montañeses 2325, CABA, Buenos Aires

CEN Centro Especializado en Neurociencias

Recruiting

Barrio General Paz D. Faustino Sarmiento 1564 - Córdoba 5004

Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

Recruiting

Av Entre Ríos 1981 CABA C1133AAH - CABA

L2IP Instituto de Pesquisas Clínicas - Brasilia

Recruiting

SGAS 613, Conj. E Bloco A , Sala 06 - Subsolo , Asa Sul - Brasília/DF, CEP: 70.200-730

StudyADEPT-4

SponsorKaruna Therapeutics

Study typeInterventional

Conditions

Alzheimer disease

Requirements

To 90 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06585787