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
- Brasília, Rio de Janeiro, and São Paulo, BrazilSee the 7 sites
- Phase
- Phase 3
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 Brazil
- L2 Ip Instituto de Pesquisas Clinicas Ltda MEBrasília, BrazilTaking people
- Ruschel MedicinaRio de Janeiro, BrazilTaking people
- BR Trials - Pesquisa ClínicaSão Paulo, BrazilTaking people
- CliniliveSão Paulo, BrazilTaking people
- CPQuali Pesquisa Clínica Sao PauloSão Paulo, BrazilTaking people
- Hospital Alemao Oswaldo Cruz (HAOC)São Paulo, BrazilTaking people
- Instituto de Psiquiatria HC FMUSPSão Paulo, BrazilTaking 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.