Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la seguridad y eficacia de KarXT en el tratamiento de la psicosis asociada a la enfermedad de Alzheimer

ReclutandoFase 3ClinicalTrials.gov

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

Resumen

El propósito de este estudio es evaluar la seguridad y eficacia de KarXT en participantes adultos con enfermedad de Alzheimer (EA) de leve a grave con psicosis de moderada a grave relacionada con la EA.

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

Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Ricardo Corral, Site 5001 · 5491144455572

RECRUITING

Local Institution - 5008

Rosario, Santa Fe Province, Argentina

Site 5008

NOT_YET_RECRUITING

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Maria Cecilia Fernandez, Site 5002 · 5411500000x00

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

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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