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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06585787Tipo: INTERVENTIONALInicio: 26 de sept de 2024Fin estimado: 19 de oct de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Elegibilidad

Edad mínima: 55 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

\- 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.

Intervenciones

drug

KarXT

Specified dose on specified days

drug

Placebo

Specified dose on specified days

Ubicaciones

CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Griselda Russo, Site 5004 · 8888888888

RECRUITING

Local Institution - 5005

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 5005

NOT_YET_RECRUITING

Local Institution - 5001

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 5001

NOT_YET_RECRUITING

Local Institution - 5008

Rosario, Santa Fe Province, Argentina

Site 5008

NOT_YET_RECRUITING

Local Institution - 5002

Buenos Aires, Argentina

Site 5002

NOT_YET_RECRUITING

Local Institution - 5009

Buenos Aires, Argentina

Site 5009

NOT_YET_RECRUITING

Local Institution - 5006

Buenos Aires, Argentina

Site 5006

NOT_YET_RECRUITING

Local Institution - 5003

Córdoba, Argentina

Site 5003

NOT_YET_RECRUITING

Local Institution - 5007

San Rafael, Argentina

Site 5007

NOT_YET_RECRUITING

Patrocinadores

PrincipalKaruna Therapeutics

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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