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: May 8, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

3

Condition

Dementia

Schizophrenia And Schizoaffective Disorders (Pediatric)

Psychosis

Treatment

KarXT

KarX-EC

KarXT + KarX-EC Arm Matching Placebo

Clinical Study ID

NCT06947941
CN012-0034
U1111-1318-5718
2025-521057-16
  • 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 2024revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer'sAssociation 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 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: 325
Treatment Group(s): 3
Primary Treatment: KarXT
Phase: 3
Study Start date:
March 25, 2026
Estimated Completion Date:
March 20, 2028

Connect with a study center

  • Local Institution - 0020

    Macquarie Park, New South Wales 2113
    Australia

    Site Not Available

  • Local Institution - 0052

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Local Institution - 0054

    Toronto, Ontario M6J1H4
    Canada

    Site Not Available

  • Local Institution - 0027

    Whitby, Ontario L1N 5S9
    Canada

    Site Not Available

  • Local Institution - 0025

    Montreal, Quebec H4H 1R3
    Canada

    Site Not Available

  • Local Institution - 0040

    Suita, Osaka 565-0871
    Japan

    Site Not Available

  • Local Institution - 0035

    Nankoku-shi, 783-8505
    Japan

    Site Not Available

  • Local Institution - 0034

    Osaka, 550-0006
    Japan

    Site Not Available

  • Local Institution - 0005

    Exeter, Devon EX12LU
    United Kingdom

    Site Not Available

  • Local Institution - 0018

    Saint Leonards-on-Sea, East Sussex TN61HB
    United Kingdom

    Site Not Available

  • Local Institution - 0023

    London, England W1G 8TA
    United Kingdom

    Site Not Available

  • Local Institution - 0015

    Oxford, Oxfordshire OX3 7JX
    United Kingdom

    Site Not Available

  • Local Institution - 0009

    Chertsey, Surrey KT160PZ
    United Kingdom

    Site Not Available

  • Local Institution - 0017

    Sheffield, Yorkshire and the Humber S47QQ
    United Kingdom

    Site Not Available

  • Local Institution - 0024

    London, WC1N3BG
    United Kingdom

    Site Not Available

  • Local Institution - 0004

    Motherwell, ML1 4UF
    United Kingdom

    Site Not Available

  • Local Institution - 0042

    Gilbert, Arizona 85297
    United States

    Site Not Available

  • Inland Psychiatric Medical Group.

    Chino, California 91710
    United States

    Active - Recruiting

  • Local Institution - 0001

    Naples, Florida 34105
    United States

    Site Not Available

  • Local Institution - 1401

    Naples, Florida 34105
    United States

    Site Not Available

  • Local Institution - 0029

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Local Institution - 0043

    Shaker Heights, Ohio 44122-5288
    United States

    Site Not Available

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