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ADEPT-4 Study: KarXT for Psychosis in Alzheimer's Disease

This study, called ADEPT-4, is testing a drug called KarXT to see if it can help with psychosis (hallucinations and delusions) in people who have Alzheimer's disease. Researchers want to know if KarXT is safe and effective for adults aged 55 to 90 with mild to severe Alzheimer's disease who also experience moderate to severe psychosis. You would be given either KarXT or a placebo (an inactive substance that looks like the drug). The main goal is to see how much the hallucinations and delusions improve over about 14 weeks. The study plans to enroll 406 participants. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 406 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes up to Week 14, suggesting follow-up for at least this duration.

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

NCT06585787

A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Recruiting
PHASE3Ages 55–90InterventionalTreatment
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
~406 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:KarXTPlacebo

At a glance

Recruiting sites
160 of 293 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Measured over Up to Week 14

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's DiseasePsychosis

Where it's being run

293 sites across 108 states
Florida46
Texas10
California9
Serbia7
Poland6
Romania6
Seoul Teugbyeolsi6
Spain6

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

What this trial measures

  • Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) scoreUp to Week 14