Status:
NOT_YET_RECRUITING
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Alzheimer Disease
Psychosis
Eligibility:
All Genders
55-90 years
Phase:
PHASE3
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
- 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
- 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.
Key Trial Info
Start Date :
July 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2027
Estimated Enrollment :
1046 Patients enrolled
Trial Details
Trial ID
NCT06947941
Start Date
July 31 2025
End Date
October 25 2027
Last Update
April 27 2025
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