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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Gilbert Neurology Partners/CCT Research
  Gilbert, Arizona, United States Recruiting
• Inland Psychiatric Medical Group.
  Chino, California, United States Recruiting
• Insight Clinical Trials LLC - Independence
  Independence, Ohio, United States Recruiting
• Local Institution - 0001
  Naples, Florida, United States Withdrawn
• Local Institution - 1401
  Naples, Florida, United States Not yet recruiting
• Local Institution - 0029
  Cleveland, Ohio, United States Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.