Recruiting
Phase 3

KarXT & KarX-EC

Sponsor:

Bristol-Myers Squibb

Code:

NCT06947941

Conditions

Alzheimer Disease

Psychosis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

KarXT

KarX-EC

KarXT + KarX-EC Arm Matching Placebo

Study Details

Brief summary:

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

Conditions

Alzheimer Disease

Psychosis

Study ID

NCT06947941

Start date

Mar 25, 2026

Status verified date

Jun, 2026

Completion date

Mar 20, 2028

Anticipated

Primary completion date

Feb 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

experimental: KarXT + KarX-EC Arm

Interventions

KarXT

Specified dose on specified days

KarX-EC

Specified dose on specified days

KarXT + KarX-EC Arm Matching Placebo

Specified dose on specified days

Primary outcome measure

  • Change From Baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) Score [ Time Frame: Up to approximately Week 14 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

Gilbert Neurology Partners/CCT Research

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Jonathan Hodgson, Site 0042

602-761-9631

Inland Psychiatric Medical Group.

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 0031

909-488-9116

Insight Clinical Trials LLC - Independence

Recruiting

Independence, Ohio, United States, 44131

Contacts

Mark Stillman, Site 0043

216-444-8897

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Alzheimer disease
  • Alzheimer's disease
  • Alzheimer's
  • Dementia
  • Psychosis
  • Alzheimer's disease psychosis
  • Alzheimer's disease psychosis with or without agitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-06-30.