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KarXT plus KarX-EC for psychosis in Alzheimer's disease

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Psychosis Associated With Alzheimer's Disease

Phase 3 Interventional Bristol-Myers Squibb · NCT06947941

This trial tests whether taking KarXT together with KarX-EC can reduce hallucinations and delusions in people aged 55–90 with psychosis related to Alzheimer's disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment325 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations22 sites (Gilbert, Arizona and 21 other locations)
Trial IDNCT06947941 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, placebo-controlled trial comparing KarXT plus KarX-EC to matching placebo in people with Alzheimer's-related psychosis. Eligible participants are adults 55–90 with an Alzheimer's diagnosis by the 2024 criteria and at least two months of psychotic symptoms; a recent brain MRI or CT is required to exclude other causes. Participants are randomized to receive active treatment or placebo and followed for measures of psychosis severity, safety, and tolerability. The trial is sponsored by Bristol-Myers Squibb and conducted at multiple U.S. clinical sites.

Who should consider this trial

Good fit: Ideal candidates are adults 55–90 with a 2024-criteria diagnosis of Alzheimer's disease and at least two months of psychotic symptoms who can undergo brain imaging and attend a participating site.

Not a fit: People whose psychosis is primarily due to another medical condition or who do not meet the age, diagnostic, or imaging requirements are unlikely to receive benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could reduce psychotic symptoms like hallucinations and delusions and improve daily function and quality of life for people with Alzheimer's-related psychosis.

How similar studies have performed: Earlier-phase trials of xanomeline-based treatments including KarXT showed promise for psychosis in schizophrenia and preliminary Alzheimer's work, but this specific combination is being tested in a larger phase 3 program.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseasePsychosisAlzheimer diseaseAlzheimer's diseaseAlzheimer'sDementiaAlzheimer's disease psychosisAlzheimer's disease psychosis with or without agitation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.