Clinical Trials in South Korea / NCT06585787
Recruiting
Phase 3
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
NCT06585787 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Alzheimer Disease
Investigational drug(s) / intervention(s)
KarXT →Placebo
KarXT: Specified dose on specified days
Placebo: Specified dose on specified days
Study summary
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.
Eligibility
Inclusion Criteria
* 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 Criteria
\- Patients will not be able to participate if they have:
i) 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.
ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.
\* Other protocol-defined Inclusion/Exclusion criteria apply.
Primary outcome measure(s)
- Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score — Up to Week 14
Trial sites (296)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 1227 | Chandler | Arizona | Completed |
| Gilbert Neurology Partners - PLLC - Avacare | Gilbert | Arizona | Recruiting |
| Banner Alzheimer's Institute | Phoenix | Arizona | Recruiting |
| Local Institution - 1220 | Scottsdale | Arizona | Completed |
| Advanced Research Center, Inc. | Anaheim | California | Recruiting |
| Inland Psychiatric Medical Group (IPMG)-Chino | Chino | California | Recruiting |
| Local Institution - 1230 | Long Beach | California | Completed |
| USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) | Los Angeles | California | Recruiting |
| Local Institution - 1219 | Los Angeles | California | Withdrawn |
| Local Institution - 1001 | Orange | California | Completed |
| Local Institution - 1228 | Orange | California | Completed |
| Local Institution - 1043 | Pasadena | California | Active Not Recruiting |
| Local Institution - 1213 | Rancho Cucamonga | California | Active Not Recruiting |
| University of Connecticut Health Center | Farmington | Connecticut | Recruiting |
| Local Institution - 1225 | Atlantis | Florida | Completed |
| Envision Trials LLC | Bonita Springs | Florida | Recruiting |
| Local Institution - 1138 | Cutler Bay | Florida | Active Not Recruiting |
| Arrow Clinical Trials | Daytona Beach | Florida | Recruiting |
| Local Institution - 1224 | Deerfield Beach | Florida | Completed |
| Local Institution - 1164 | Doral | Florida | Active Not Recruiting |
| Local Institution - 1264 | Gulf Breeze | Florida | Not Yet Recruiting |
| Local Institution - 1120 | Hialeah | Florida | Active Not Recruiting |
| Local Institution - 1237 | Hialeah | Florida | Completed |
| Local Institution - 1229 | Homestead | Florida | Active Not Recruiting |
| Local Institution - 1040 | Lady Lake | Florida | Completed |
| Local Institution - 1159 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1021 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1125 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1236 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1115 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1010 | Miami | Florida | Completed |
| Local Institution - 1143 | Miami | Florida | Completed |
| Local Institution - 1113 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1129 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1150 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1006 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1111 | Miami | Florida | Active Not Recruiting |
| Local Institution - 1158 | Miami | Florida | Completed |
| Local Institution - 1235 | Miami | Florida | Completed |
| Local Institution - 1147 | Miami | Florida | Completed |
+ 256 more sites — see the full list on the official registry below.
More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in South Korea
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Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06585787 on ClinicalTrials.gov ↗ ← All trials in South Korea