RECRUITINGPhase 3INTERVENTIONAL
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
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
About This Trial
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.
Who May Be Eligible (Plain English)
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
KarXT
Specified dose on specified days
DRUG
Placebo
Specified dose on specified days
Locations (20)
Chandler Clinical Trials, LLC
Chandler, Arizona, United States
Gilbert Neurology Partners - PLLC - Avacare
Gilbert, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Inland Psychiatric Medical Group (IPMG)-Chino
Chino, California, United States
Long Beach Research Institute, LLC
Long Beach, California, United States
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California, United States
Local Institution - 1219
Los Angeles, California, United States
Local Institution - 1001
Orange, California, United States
NRC Research Institute - Orange - PPDS
Orange, California, United States
SC3 Research - Pasadena - 960 E. Green St
Pasadena, California, United States
Prospective Research Innovations 8577 Haven Ave
Rancho Cucamonga, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Genesis Trust Research Group
Atlantis, Florida, United States
Envision Trials LLC
Bonita Springs, Florida, United States
JY Research Institute Inc
Cutler Bay, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Quantum Laboratories, Inc - West Palm Beach Office
Deerfield Beach, Florida, United States
Integrity Clinical Research LLC - 21st Street
Doral, Florida, United States