KarXT Tested for Psychosis in People With Alzheimer's Disease
Tests KarXT against placebo in adults with Alzheimer's and psychosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Guangzhou, Hangzhou, Kunming, Nanjing, Ningbo, Shanghai, Shenzhen, Tianjin, Xi'an, and Zhenjiang, ChinaSee the 22 sites
- Phase
- Phase 3
AI summary: who the study is looking for
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
Read by machine on 9 November 2026.
Could this be for you?
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?
Source: NCT06585787, who can take part
Where in China
- Beijing Anding Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Beijing HospitalBeijing, ChinaTaking people
- China-Japan Friendship HospitalBeijing, ChinaTaking people
- Xiangya Hospital Central South UniversityChangsha, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- GuangzhouGuangzhou, ChinaNo longer taking part
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qiantang CampusHangzhou, ChinaTaking people
- Zhejiang Hospital - Lingyin CampusHangzhou, ChinaTaking people
- Zhejiang Provincial People's HospitalHangzhou, ChinaTaking people
- First Affiliated Hospital of Kunming Medical UniversityKunming, ChinaTaking people
- Nanjing Brain HospitalNanjing, ChinaTaking people
- The Second Affiliated Hospital of Nanjing Medical University - Main CampusNanjing, ChinaTaking people
- The Affiliated Kangning Hospital of Ningbo University - Zhuangshi CampusNingbo, ChinaTaking people
- ShanghaiShanghai, ChinaNot yet recruiting
- Shanghai Mental Health Center - PPDSShanghai, ChinaTaking people
- Tongji Hospital of Tongji UniversityShanghai, ChinaTaking people
- Shenzhen Kangning HospitalShenzhen, ChinaTaking people
- Tianjin Anding Hospital(Tianjin mental Health Center)Tianjin, ChinaTaking people
- The Mental Health Center of Xi'anXi'an, ChinaTaking people
- Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Trial code
- NCT06585787EU 2024-516363-92-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
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).
Exclusion: 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.