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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06947941

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
325
US sites recruiting
3
Study start
March 25, 2026
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KarXT; KarX-EC; KarXT + KarX-EC Arm Matching Placebo

Conditions: Alzheimer Disease; Psychosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Gilbert Neurology Partners/CCT Research

    Gilbert, AZ 85297

    Site contact: Jonathan Hodgson, Site 0042 · 602-761-9631

  • Inland Psychiatric Medical Group.

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 0031 · 909-488-9116

  • Insight Clinical Trials LLC - Independence

    Independence, OH 44131

    Site contact: Mark Stillman, Site 0043 · 216-444-8897

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a… (NCT06947941) | Bored Studies