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KarXT for psychosis in people with Alzheimer's disease

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

PHASE3 · Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT06126224

This Phase 3 test will see if KarXT reduces hallucinations and delusions in people aged 55–90 who have Alzheimer's-related psychosis.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment500 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company (industry)
Locations154 sites (Chandler, Arizona and 153 other locations)
Trial IDNCT06126224 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men or women aged 55–90 with possible or probable Alzheimer's disease and moderate to severe psychosis, who have a recent MRI/CT, live with or in the same facility for at least six weeks, and have a study partner with daily contact.

Not a fit: People without AD-related psychosis, those outside the 55–90 age range, individuals lacking a regular study partner or recent brain imaging, or those whose dementia is explained by other CNS disease are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, KarXT could reduce hallucinations and delusions in people with Alzheimer's-related psychosis and offer a new treatment option that may relieve symptoms and caregiver burden.

How similar studies have performed: KarXT has produced positive results in schizophrenia trials and early-phase work suggested potential for dementia-related psychosis, but larger Phase 3 data are needed to confirm benefit in Alzheimer's-related psychosis.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 153 other locations

+104 more sites — see ClinicalTrials.gov for the full list.

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 →

Conditions: Psychosis Associated With Alzheimer's Disease

Last reviewed 2026-05-15 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.