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Phase 3Recruiting

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

Sponsored by Bristol-Myers Squibb

About this study

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Where this study is enrolling (3)

  • Gilbert Neurology Partners/CCT Research

    Gilbert, Arizona

    Call 602-761-9631

    This research site can be reached directly by phone. Call to ask about this study.

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  • Inland Psychiatric Medical Group.

    Chino, California

    Call 909-488-9116

    This research site can be reached directly by phone. Call to ask about this study.

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  • Insight Clinical Trials LLC - Independence

    Independence, Ohio

    Call 216-444-8897

    This research site can be reached directly by phone. Call to ask about this study.

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Who can participate

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 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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.