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

Last updated: April 25, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

3

Condition

Schizophrenia And Schizoaffective Disorders (Pediatric)

Schizotypal Personality Disorder (Spd)

Psychosis

Treatment

KarX-EC

KarXT + KarX-EC Arm Matching Placebo

KarXT

Clinical Study ID

NCT06947941
CN012-0034
  • Ages 55-90
  • All Genders

Study 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

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 2024NIA-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 orsubsequent 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 InternationalPsychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion

Exclusion Criteria:

  • Participants must not have psychotic symptoms that are primarily attributable to acondition other than the AD causing the dementia, eg, schizophrenia, schizoaffectivedisorder, delusional disorder, or mood disorder with psychotic features.

  • Participants must not have history of major depressive episode with psychoticfeatures 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 laboratorytest irregularities.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 1046
Treatment Group(s): 3
Primary Treatment: KarX-EC
Phase: 3
Study Start date:
July 31, 2025
Estimated Completion Date:
October 25, 2027