ADEPT-2 Study: KarXT for Psychosis in Alzheimer's Disease

This study is testing KarXT to see if it can help treat psychosis (hallucinations and delusions) in people with Alzheimer's disease. Researchers want to know if KarXT is safe and effective compared to a placebo (a pill with no medicine). You may be able to join if you are 55 to 90 years old, have mild to severe Alzheimer's disease, and experience moderate to severe psychosis. The study will measure changes in hallucinations and delusions to see how well KarXT works. The study plans to enroll about 500 participants, but its current status is unclear.

Study design
This is a Phase 3 study, meaning it's a later-stage trial. It's designed as a randomized, double-blind, placebo-controlled study, involving about 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured up to 14 weeks after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06126224

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Recruiting
PHASE3Ages 55–90InterventionalTreatment
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
~500 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:KarXTPlacebo

At a glance

Recruiting sites
7 of 154 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Measured over Baseline and end of Treatment (up to 14 Weeks)
Psychosis Associated With Alzheimer's Disease
154 sites across 61 states
Florida44
California7
United Kingdom7
Texas5
Zhejiang5
Poland5
Guangdong4
Attica4
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Email the study team

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  • Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) scoreBaseline and end of Treatment (up to 14 Weeks)

    Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.