A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Launched by BRISTOL-MYERS SQUIBB · Apr 25, 2025

Keywords

ClinConnect Summary

The ADEPT-5 clinical trial is studying a new treatment called KarXT + KarX-EC for people with Alzheimer's disease who are experiencing psychosis, which can include symptoms like hallucinations or delusions. The goal is to find out if this treatment is safe and effective in helping manage these symptoms in individuals diagnosed with Alzheimer's. The trial is not yet open for participants, but when it is, it will be looking for adults aged 55 to 90 who have been diagnosed with Alzheimer’s disease and have had psychotic symptoms for at least two months.

To participate, individuals will need to have a brain scan done in the last five years to rule out other potential causes of their symptoms. However, those with a history of certain mental health conditions, like schizophrenia or major mood disorders, won't be eligible. Participants will be closely monitored throughout the trial to assess their health and response to the treatment. This study is an important step in finding new ways to help those affected by Alzheimer's-related psychosis.

Gender

ALL

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 NIA-AA criteria.
• • 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 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.