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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
406
Start Date
2024-09-26
Completion Date
2026-12-22
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (296)
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
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
McLean Hospital
Belmont, Massachusetts, United States
Tufts Medical Center - 800 Washington St - PPDS
Boston, Massachusetts, United States
Boston Neuro Research Center
North Dartmouth, Massachusetts, United States
Local Institution - 1250
South Dartmouth, Massachusetts, United States
Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts, United States
Neurobehavioral Medicine Group (NBMG)
Bloomfield Township, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Tekton Research, LLC - Saint Louis Psychiatry - PPDS
St Louis, Missouri, United States
Advanced Memory Research Institute - CenExel - PPDS
Toms River, New Jersey, United States
Local Institution - 1232
Toms River, New Jersey, United States
Mid Hudson Medical Research PLLC
New Windsor, New York, United States
Local Institution - 1231
Syracuse, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Five Towns Neurology, PC
Woodmere, New York, United States
Triad Clinical Trials - 515 College Rd
Greensboro, North Carolina, United States
AMC Research, LLC - Flourish - PPDS
Matthews, North Carolina, United States
Local Institution - 5005
Morehead City, North Carolina, United States
West Clinical Research
Morehead City, North Carolina, United States
Local Institution - 1252
Shelby, North Carolina, United States
Local Institution - 1265
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Local Institution - 1258
Dayton, Ohio, United States
Insight Clinical Trials LLC - Independence
Independence, Ohio, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
Providence, Rhode Island, United States
Local Institution - 1267
Columbia, South Carolina, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
Senior Adults Specialty Research
Austin, Texas, United States
Local Institution - 1260
Dallas, Texas, United States
Epic Medical Research LLC - DeSoto
DeSoto, Texas, United States
Advanced Neuro Research Center - El Paso
El Paso, Texas, United States
Local Institution - 1262
Fort Worth, Texas, United States
Local Institution - 1261
Houston, Texas, United States
University Hills Clinical Research - 102 Decker Ct
Irving, Texas, United States
Local Institution - 1238
Plano, Texas, United States
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas, United States
Local Institution - 1134
Stafford, Texas, United States
Local Institution - 1266
Salem, Virginia, United States
Conquest Research, LLC - Virginia - Vienna
Vienna, Virginia, United States