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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CN012-0056  |   NCT06585787

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease

Resumen

  • Phase 3
  • Ícono de género masculino y femenino
  • 55-90
  • 27
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

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.

Centro de reclutamiento más cercano

Criterios clave de elegibilidad

Criterios de inclusión

Criterios de inclusión Icon
  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
    1. Patients who are diagnosed with possible AD or probable AD (refer to the appendix for the National Institute on Aging
      1. Alzheimer's Association Guidelines for All-cause Dementia and Alzheimer's Disease).
        1. 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.
          1. 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

            Criterios de exclusión Icon
            • Patients will not be able to participate if they have:.
              1. 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.
                1. History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
                  1. Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
                  Información Adicional *
                  • Other protocol-defined Inclusion/Exclusion criteria apply.

                    Opciones de tratamiento

                    Brazos del estudio

                    INTERVENCIÓN ASIGNADA

                    Brazos del estudio

                    Experimental: KarXT

                    INTERVENCIÓN ASIGNADA
                    • Drug: KarXT

                    Brazos del estudio

                    Experimental: Placebo

                    INTERVENCIÓN ASIGNADA
                    • Drug: Placebo
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