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Evaluating KarXT for treating psychosis in Alzheimer's patients

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

Phase 3 Interventional Karuna Therapeutics, Inc., a Bristol Myers Squibb company · NCT06585787

This study is testing a new treatment called KarXT to see if it can help older adults with Alzheimer's who are experiencing severe psychosis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment406 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored
Locations288 sites (Chandler, Arizona and 287 other locations)
Trial IDNCT06585787 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 55 to 90 diagnosed with Alzheimer's Disease and experiencing moderate to severe psychotic symptoms.

Not a fit: Patients whose psychotic symptoms are primarily due to conditions other than Alzheimer's Disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for Alzheimer's patients suffering from psychosis.

How similar studies have performed: Other studies have explored treatments for psychosis in Alzheimer's, but the specific use of KarXT represents a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Chandler, Arizona and 287 other locations

+238 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 → Find more trials like this →
Conditions Alzheimer DiseaseAlzheimer's DiseaseADADEPT4ADEPT-4KarXTPsychosis
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.