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Status:

RECRUITING

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Lead Sponsor:

Karuna Therapeutics

Conditions:

Alzheimer Disease

Eligibility:

All Genders

55-90 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
  • Patients who are diagnosed with AD based on the 2024 National Institute on Aging - Alzheimer's Association criteria with AD biomarker confirmation.
  • Patient 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.
  • Patient 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
  • \- Patients will not be able to participate if they have:.
  • i) 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.
  • ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    September 26 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 19 2026

    Estimated Enrollment :

    406 Patients enrolled

    Trial Details

    Trial ID

    NCT06585787

    Start Date

    September 26 2024

    End Date

    October 19 2026

    Last Update

    January 8 2026

    Active Locations (261)

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    Page 1 of 66 (261 locations)

    1

    Chandler Clinical Trials, LLC

    Chandler, Arizona, United States, 85224

    2

    Gilbert Neurology Partners - PLLC - Avacare

    Gilbert, Arizona, United States, 85297

    3

    Banner Alzheimer's Institute

    Phoenix, Arizona, United States, 85006-2528

    4

    Scottsdale Clinical Trials

    Scottsdale, Arizona, United States, 85260-6742