Evaluating KarXT for treating psychosis in Alzheimer's patients

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 study aims to assess the safety and effectiveness of KarXT in adults aged 55 to 90 who have been diagnosed with Alzheimer's Disease and are experiencing moderate to severe psychosis. Participants will be randomly assigned to receive either KarXT or a placebo, with the goal of determining how well KarXT alleviates psychotic symptoms associated with Alzheimer's. The study will include patients with confirmed Alzheimer's biomarkers and a history of psychotic symptoms for at least two months. The trial is designed to provide insights into a potential new treatment option for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
* Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
* Patient 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.
* Patient 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

\- Patients will not be able to participate if they have:

i) 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.

ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

\* Other protocol-defined Inclusion/Exclusion criteria apply.

Where it's running

• Gilbert Neurology Partners - PLLC - Avacare
  Gilbert, Arizona, United States Recruiting
• Banner Alzheimer's Institute
  Phoenix, Arizona, United States Recruiting
• Advanced Research Center, Inc.
  Anaheim, California, United States Recruiting
• Inland Psychiatric Medical Group (IPMG)-Chino
  Chino, California, United States Recruiting
• USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
  Los Angeles, California, United States Recruiting
• University of Connecticut Health Center
  Farmington, Connecticut, United States Recruiting

+246 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.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.