KarXT for psychosis in people with 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 randomized, double-blind, placebo-controlled, parallel-group Phase 3 study comparing KarXT with placebo in adults aged 55–90 who have mild to severe Alzheimer's disease and moderate to severe psychosis. The primary outcome is change in the Neuropsychiatric Inventory–Clinician (NPI-C) Hallucinations and Delusions score. Participants must have recent brain imaging to exclude other causes of dementia, live in the same home or assisted-living facility for at least six weeks, and have an identified study partner with regular daily contact. Dosing and safety are monitored throughout the trial with clinical assessments at scheduled in-person visits at participating sites.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Is a male or female aged 55 to 90 years, inclusive, at Screening.
2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
3. Meets clinical criteria for Possible AD or Probable AD.
4. 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, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening.
5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more).
7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
8. CGI-S scale with a score ≥ 4 at Screening and Baseline.
9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline:

   1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
   2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
10. MMSE score of 8 to 22, inclusive, at Screening.

Key Exclusion Criteria:

1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
2. History of major depressive episode with psychotic features during the 12 months prior to Screening.
3. History of bipolar disorder, schizophrenia, or schizoaffective disorder.
4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
6. Prior exposure to KarXT.
7. History of hypersensitivity to KarXT excipients or trospium chloride.
8. Experienced any significant adverse events (AEs) due to trospium.
9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening.
10. Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• Health Synergy Clinical Research,LLC - Stuart
  Stuart, Florida, United States Recruiting
• Local Institution - 1131
  Viera, Florida, United States Recruiting
• Local Institution - 1106
  Cypress, Texas, United States Recruiting
• Biomedica Research Group
  Providencia, Santiago Metropolitan, Chile Recruiting
• Psicomed Estudios Medicos
  Antofagasta, Chile Recruiting
• Local Institution - 6001
  Las Condes, Chile Recruiting

+107 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ML-007C-MA for hallucinations and delusions in Alzheimer's disease

  This will test whether ML-007C-MA reduces hallucinations and delusions in people aged 55–90 with Alzheimer's-related psychosis.

  Recruiting at 61 sites Phase 2 MapLight Therapeutics · Phoenix, Arizona and 61 other locations · NCT06887192

• Long-term safety assessment of KarXT for Alzheimer's-related psychosis

  This study is testing the long-term safety of a treatment called KarXT for people with Alzheimer's-related psychosis who have already participated in earlier trials.

  Recruiting at 132 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Homewood, Alabama and 431 other locations · NCT05980949

• Evaluating KarXT for treating psychosis in Alzheimer's patients

  This study is testing a new treatment called KarXT to see if it can help people with Alzheimer's who are experiencing psychosis and prevent them from getting worse.

  Recruiting at 36 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Homewood, Alabama and 128 other locations · NCT05511363

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.