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A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
1046 patients around the world
Bristol-Myers Squibb
1Research sites
1046Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 90 Years
All Gender
Medical requirements
- Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 NIA-AA criteria.Participants 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, eg, major stroke, neoplasm, subdural hematoma.Participants must have a history of psychotic symptoms for at least 2 months prior to Screening (Visit 1).
- Participants must not have 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.Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.Participants must not have certain safety concerns, including certain laboratory test irregularities.Other protocol-defined Inclusion/Exclusion criteria apply.
Sites
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
StudyADEPT-5
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Alzheimer disease
Requirements
To 90 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06947941
