A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)

Recruiting · NCT06585787 · Interventional (participants receive a specific treatment) · Lead sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

View the official record on ClinicalTrials.gov →

Schizophrenia Alzheimer's disease

Interventions studied

KarXTPlacebo

What this trial is about

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 can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 19 US states.

Local Institution - 1227 - Chandler, Arizona, United States
Gilbert Neurology Partners - PLLC - Avacare - Gilbert, Arizona, United States
Banner Alzheimer's Institute - Phoenix, Arizona, United States
Local Institution - 1220 - Scottsdale, Arizona, United States
Advanced Research Center, Inc. - Anaheim, California, United States
Inland Psychiatric Medical Group (IPMG)-Chino - Chino, California, United States
Local Institution - 1230 - 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
Local Institution - 1228 - Orange, California, United States
Local Institution - 1043 - Pasadena, California, United States
Local Institution - 1213 - Rancho Cucamonga, California, United States
University of Connecticut Health Center - Farmington, Connecticut, United States
Local Institution - 1225 - Atlantis, Florida, United States
Envision Trials LLC - Bonita Springs, Florida, United States
Local Institution - 1138 - Cutler Bay, Florida, United States
Arrow Clinical Trials - Daytona Beach, Florida, United States
Local Institution - 1224 - Deerfield Beach, Florida, United States
Local Institution - 1164 - Doral, Florida, United States
Local Institution - 1264 - Gulf Breeze, Florida, United States
Local Institution - 1120 - Hialeah, Florida, United States
Local Institution - 1237 - Hialeah, Florida, United States
Local Institution - 1229 - Homestead, Florida, United States
Local Institution - 1040 - Lady Lake, Florida, United States
Local Institution - 1159 - Miami, Florida, United States
Local Institution - 1021 - Miami, Florida, United States
Local Institution - 1125 - Miami, Florida, United States
Local Institution - 1236 - Miami, Florida, United States
Local Institution - 1115 - Miami, Florida, United States
Local Institution - 1010 - Miami, Florida, United States
Local Institution - 1143 - Miami, Florida, United States
Local Institution - 1113 - Miami, Florida, United States
Local Institution - 1129 - Miami, Florida, United States
Local Institution - 1150 - Miami, Florida, United States
Local Institution - 1006 - Miami, Florida, United States
Local Institution - 1111 - Miami, Florida, United States
Local Institution - 1158 - Miami, Florida, United States
Local Institution - 1235 - Miami, Florida, United States
Local Institution - 1147 - Miami, Florida, United States
Local Institution - 1234 - Miami, Florida, United States
Local Institution - 1105 - Miami, Florida, United States
Local Institution - 1157 - Miami, Florida, United States
Local Institution - 1126 - Miami Gardens, Florida, United States
Local Institution - 1209 - Miami Lakes, Florida, United States
Local Institution - 1118 - Miami Lakes, Florida, United States
Aqualane Clinical Research - Naples, Florida, United States
Sensible HealthCare, LLC - Ocoee, Florida, United States
Charter Research Orlando - Orlando, Florida, United States
Nova Psychiatry - Orlando, Florida, United States
Combined Research Orlando Phase I-IV LLC - Orlando, Florida, United States
Local Institution - 1204 - Ormond Beach, Florida, United States
Local Institution - 1205 - Port Orange, Florida, United States
Local Institution - 1133 - Sweetwater, Florida, United States
Local Institution - 1123 - Tampa, Florida, United States
Guardian Angel Research - Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay - Tampa, Florida, United States
Charter Research - The Villages, Florida, United States
Local Institution - 1233 - Wellington, Florida, United States
Premiere Research Institute at Palm Beach Neurology, PA - West Palm Beach, Florida, United States

Showing 60 of 293 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →