RecruitingPhase 3NCT06947941
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease
Sponsor
Bristol-Myers Squibb
Enrollment
325 participants
Start Date
Mar 25, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.
Eligibility
Min Age: 55 YearsMax Age: 90 Years
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
DRUGKarXT
Specified dose on specified days
DRUGKarX-EC
Specified dose on specified days
DRUGKarXT + KarX-EC Arm Matching Placebo
Specified dose on specified days
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT06947941
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