NCT06947941 A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
| NCT ID | NCT06947941 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 325 participants |
| Start Date | 2026-03-25 |
| Primary Completion | 2028-03-20 |
Trial Parameters
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Brief Summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria: * 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 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup. * Participants 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. * Participants 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). Exclusion Criteria: * Participants must not have psychotic symptoms that are primarily attributable to a condition other than the
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