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Taking peoplePhase 3

KarXT Tested for Psychosis in People With Alzheimer's Disease

Tests KarXT against placebo in adults with Alzheimer's and psychosis.

Key facts

Who runs it
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Where
Alken, Jette, Kortrijk, and Roeselare, BelgiumSee the 4 sitesAlso in 24 other countries, 274 sites
Trial code
Registry title
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Status
Recruiting
Phase
Phase 3
People taking part
406 people, planned
Started
26 Sept 2024
Expected to end
22 Dec 2026
Type of study
Interventional, 2 groups
Treatments tested
  • KarXT
  • Placebo
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 55 to 90 who have Alzheimer's disease together with psychotic symptoms, such as delusions or hallucinations, caused by the disease.

Age
55 to 90 years
Sex
All sexes can join.
Disease stage
Mild to severe Alzheimer's disease with moderate to severe psychosis related to the disease. Psychotic symptoms must have been present for at least 2 months before screening.

Main reasons for not taking part

  • Psychotic symptoms mainly caused by something other than Alzheimer's disease, such as schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features
  • Major depressive episode with psychotic features in the 12 months before screening
  • History of bipolar disorder, schizophrenia or schizoaffective disorder
  • Certain safety concerns, including some abnormal laboratory test results
  • No brain MRI or CT scan from the past 5 years that rules out other brain disease

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder
  • 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
  • Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities
  • Patients will not be able to participate if they have:
  • Other protocol-defined Inclusion/Exclusion criteria apply

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 55 and 90 years old?
  • Has a doctor told you that you have Alzheimer's disease?
  • Do you have hallucinations or delusions caused by Alzheimer's disease?
  • Has a doctor ever told you that you have bipolar disorder, schizophrenia or schizoaffective disorder?

Where in Belgium

Also in 24 other countries, 274 sites

  • AnimaAlken, BelgiumNo longer taking part
  • UZ BrusselJette, BelgiumNo longer taking part
  • Algemeen Ziekenhuis GroeningeKortrijk, BelgiumNo longer taking part
  • Algemeen Ziekenhuis DeltaRoeselare, BelgiumNo longer taking part

About the trial

What the trial wants to find out

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

The 2 groups in the trial

  • KarXTTreatment being tested
  • PlaceboTreatment being tested

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
KarXT Tested for Psychosis in People With Alzheimer's DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06585787, who can take part
Record updated
27 October 2026