A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Part of paid clinical trials in Chandler, Arizona.
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Study ID
- NCT06585787
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - 90 Years
- Healthy Volunteers
- Not accepted
Interventions
- KarXT — DRUGSpecified dose on specified days
- Placebo — DRUGSpecified dose on specified days
Study Details
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.
Key Dates
- Start date
- Sep 26, 2024
- Status verified
- Jun 2026
- Primary completion
- Nov 24, 2026
- Completion
- Dec 22, 2026
Study Design
- Enrollment
- 406 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: KarXT
- Experimental: Placebo
Primary Outcome Measure
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score [ Time Frame: Up to Week 14 ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (98)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Chandler Clinical Trials, LLC | Chandler | Arizona | 85224 | Muhammad (Osman) Salim Khan, Site 1227 480-716-4590 |
| Gilbert Neurology Partners - PLLC - Avacare | Gilbert | Arizona | 85297 | Jonathan Hodgson, Site 1247 602-761-9631 |
| Banner Alzheimer's Institute | Phoenix | Arizona | 85006-2528 | Ganesh Gopalakrishna, Site 1217 602-839-6900 |
| Scottsdale Clinical Trials | Scottsdale | Arizona | 85260-6742 | Khalid Salim, Site 1220 480-382-7909 |
| Advanced Research Center, Inc. | Anaheim | California | 92805-5854 | Steven Macina, Site 1104 714-999-6688 |
| Inland Psychiatric Medical Group (IPMG)-Chino | Chino | California | 91710 | Nandita Puchakayala, Site 1244 909-488-9116 |
| Long Beach Research Institute, LLC | Long Beach | California | 90805 | Ashley Duzik, Site 1230 562-471-3773 |
| Local Institution - 1219 | Los Angeles | California | 90095 | - |
| USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC) | Los Angeles | California | 90033-5313 | Lon Schneider, Site 1226 323-442-3715 |
| Local Institution - 1001 | Orange | California | 92866 | - |
| NRC Research Institute - Orange - PPDS | Orange | California | 92868-2847 | Daniel Chueh, Site 1228 714-289-1100 |
| SC3 Research - Pasadena - 960 E. Green St | Pasadena | California | 91106 | M. Lorraine Purino, Site 1043 626-250-2070 |
| Prospective Research Innovations 8577 Haven Ave | Rancho Cucamonga | California | 91730 | Tarek Ezzeddine, Site 1213 |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | Neha Jain, Site 1222 860-790-7354 |
| Genesis Trust Research Group | Atlantis | Florida | 33462 | Rodolfo Trejo, Site 1225 561-509-9956 |
| Envision Trials LLC | Bonita Springs | Florida | 34134 | Daniel Mandri, Site 1020 305-819-2909 |
| JY Research Institute Inc | Cutler Bay | Florida | 33189-1230 | Suez Oramas Mingo, Site 1138 305-424-8696 |
| Arrow Clinical Trials | Daytona Beach | Florida | 32117-5532 | David Billmeier, Site 1023 386-278-8000 |
| Quantum Laboratories, Inc - West Palm Beach Office | Deerfield Beach | Florida | 33442 | Jose De La Gandara, Site 1224 954-786-7331 |
| Integrity Clinical Research LLC - 21st Street | Doral | Florida | 33122-1620 | Lucinda Cuervo-Ramos, Site 1164 305-888-0410 |
| Local Institution - 1264 | Gulf Breeze | Florida | 32561 | Site 1264 |
| New Life Medical Research Center -3750 W 16th Ave | Hialeah | Florida | 33012-4648 | Jorge Betancourt, Site 1120 305-456-7782 |
| Research in Miami, Inc | Hialeah | Florida | 33013 | Dolores Sanchez Cazau, Site 1237 305-889-6670 |
| Nexus Clinical Research Center- NRC | Homestead | Florida | 33030 | John Cintron, Site 1229 |
| K2 Medical Research - Lady Lake | Lady Lake | Florida | 32159 | Craig Curtis, Site 1040 407-426-9299 |
| A & D Doctor Center | Miami | Florida | 33135-2968 | Yordan Orive Gomez, Site 1236 305-223-2000 |
| Dade Research Center - Miami FL - 7600 SW 87th Ave | Miami | Florida | 33173 | Maria Nualart, Site 1111 208-346-8900 |
| Floridian Neuroscience Institute-1901 SW 1 St | Miami | Florida | 33135 | Emilio Mantero-Atienza, Site 1115 305-326-0776 |
| Future Care Solution LLC | Miami | Florida | 33165-3947 | Pilar Trueba, Site 1129 305-888-0410 |
| High Quality Research | Miami | Florida | 33184-1412 | Jorge Gonzalez, Site 1157 305-392-0244 |
| Homestead Associates in Research Inc | Miami | Florida | 33032 | Angel Carrasco, Site 1159 786-422-7374 |
| IMIC LLC- 9380 SW 150th Str | Miami | Florida | 33176-7947 | Leon Ramon, Site 1147 786-600-7005 |
| Local Institution - 1105 | Miami | Florida | 33179-2537 | - |
| Local Institution - 1143 | Miami | Florida | 33145-2455 | - |
| Local Institution - 1158 | Miami | Florida | 33175 | - |
| Miami Jewish Health Systems | Miami | Florida | 33137 | Marc Agronin, Site 1010 3057518626x2403 |
| My Community Research Center, Inc - 7480 Bird Rd | Miami | Florida | 33155-6630 | Cesar Guerrero, Site 1113 786-359-4867 |
| New Gen Health | Miami | Florida | 33176 | Roberto Hernando, Site 1234 305-892-1035 |
| Novel Clinical Research Center, LLC. | Miami | Florida | 33173-1474 | Heber Varela, Site 1006 000-000-0000 |
| Premier Clinical Research Institute | Miami | Florida | 33122-1335 | Emelina Arocha, Site 1021 305-445-5994 |
| Reliant Medical Research | Miami | Florida | 33165 | Carlos Ramirez Calderon, Site 1150 786-801-0912 |
| Serenity Research Center | Miami | Florida | 33176-1451 | Sergio Jaramillo, Site 1235 305-596-2080 |
| Wellness Research Center Inc - Miami | Miami | Florida | 33135-1601 | Brian Villa, Site 1125 786-238-7099 |
| New Med Research | Miami Gardens | Florida | 33056-4000 | Marta Fernandez, Site 1126 305-269-7100 |
| Angels Clinical Research Institute - Miami Lakes - Palm Springs - PPDS | Miami Lakes | Florida | 33016 | Yanely Pineiro Puebla, Site 1118 786-218-1733 |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | Robert Perry, Site 1209 305-698-4500 |
| Aqualane Clinical Research | Naples | Florida | 34105 | William Justiz, Site 1246 941-436-6838 |
| Sensible HealthCare, LLC | Ocoee | Florida | 34761-2964 | Kelly Taylor, Site 1212 407-654-2724 |
| Combined Research Orlando Phase I-IV LLC | Orlando | Florida | 32807-3555 | Eric Carbonell, Site 1112 407-440-4493 |
| Local Institution - 1257 | Orlando | Florida | 32803 | Site 1257 |
| Nova Psychiatry | Orlando | Florida | 32803 | David Medina, Site 1242 407-823-8421 |
| Neurology Associates of Ormond Beach | Ormond Beach | Florida | 32174-3101 | David McDonald, Site 1204 386-673-2500 |
| Progressive Medical Research (Duplicate) | Port Orange | Florida | 32127 | Alexander White, Site 1205 386-304-7070 |
| Cordova Research Institute- Sweetwater | Sweetwater | Florida | 33182 | Delores Macksoud, Site 1133 786-631-3890 |
| Angels Clinical Research Institute Tampa - Palm Springs - PPDS | Tampa | Florida | 33614-2869 | Al Robaina, Site 1123 813-931-0128 |
| Guardian Angel Research | Tampa | Florida | 33614 | Sadaf Bazargan, Site 1124 813-300-3300 |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629-5837 | Jamie Fernandez, Site 1110 813-251-1800 |
| Local Institution - 1256 | The Villages | Florida | 32162-2698 | Site 1256 |
| Local Institution - 1233 | Wellington | Florida | 33414 | - |
| Premiere Research Institute at Palm Beach Neurology, PA | West Palm Beach | Florida | 33407-3209 | Paul Winner, Site 1216 561-845-0500 |
| Agile Clinical Research Trials, LLC | Atlanta | Georgia | 30328-5532 | Vasundhara Cheekati, Site 1206 404-382-8660 |
| McLean Hospital | Belmont | Massachusetts | 02478-1064 | Arkadiy Stolyar, Site 1223 617-855-2136 |
| Tufts Medical Center - 800 Washington St - PPDS | Boston | Massachusetts | 02111-1552 | Brent Forester, Site 1245 617-636-3202 |
| Boston Neuro Research Center | North Dartmouth | Massachusetts | 02747-2612 | Mushtaque Chachar, Site 1243 508-925-7403 |
| Local Institution - 1250 | South Dartmouth | Massachusetts | 02747 | Site 1250 |
| Elixia Health - Springfield - Elixia - PPDS | Springfield | Massachusetts | 01103 | Susan Smiga, Site 1239 413-305-1142 |
| Neurobehavioral Medicine Group (NBMG) | Bloomfield Township | Michigan | 48302-1909 | Richard Jackson, Site 1248 412-916-2425 |
| Precise Research Centers | Flowood | Mississippi | 39232 | Joseph Kwentus, Site 1132 601-420-5810 |
| Local Institution - 1255 | St Louis | Missouri | 63128 | Site 1255 |
| Advanced Memory Research Institute - CenExel - PPDS | Toms River | New Jersey | 08755 | Arun Singh, Site 1202 732-341-9500 |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | Ashok Patel, Site 1232 732-244-2299 |
| Local Institution - 1251 | New Windsor | New York | 12553-7754 | Site 1251 |
| Local Institution - 1231 | Syracuse | New York | 13203 | - |
| Local Institution - 1240 | Syracuse | New York | 13210-2306 | Site 1240 |
| Five Towns Neurology, PC | Woodmere | New York | 11598-1739 | David Steiner, Site 1025 516-239-1800 |
| Triad Clinical Trials - 515 College Rd | Greensboro | North Carolina | 27410-3311 | Richard Montgomery, Site 1221 336-235-0991 |
| AMC Research, LLC - Flourish - PPDS | Matthews | North Carolina | 28105-8336 | Mohammad Bolouri, Site 1214 704-364-4000 |
| Local Institution - 5005 | Morehead City | North Carolina | 28557 | - |
| West Clinical Research | Morehead City | North Carolina | 28557 | Patrick Morgante, Site 1215 252-515-0050 |
| Local Institution - 1252 | Shelby | North Carolina | 28150-3803 | Site 1252 |
| Ohio State University | Columbus | Ohio | 43221 | Douglas Scharre, Site 1201 614-293-4560 |
| Local Institution - 1258 | Dayton | Ohio | 45417-3445 | Site 1258 |
| Insight Clinical Trials LLC - Independence | Independence | Ohio | 44131 | Mark Stillman, Site 1249 216-444-8897 |
| The Rivus Wellness & Research Institute | Oklahoma City | Oklahoma | 73112 | Marvin Peyton, Site 1016 405-317-5783 |
| Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital | Providence | Rhode Island | 02903 | Chuang-Kuo Wu, Site 1218 714-456-7002 |
| Vanderbilt Psychiatric Hospital | Nashville | Tennessee | 37212-3133 | Jo Wilson, Site 1211 615-322-4967 |
| Local Institution - 1263 | Austin | Texas | 78757-7566 | Site 1263 |
| Local Institution - 1260 | Dallas | Texas | 75231-6079 | Site 1260 |
| Epic Medical Research LLC - DeSoto - HyperCore - PPDS | DeSoto | Texas | 75115-2043 | Haresh Boghara, Site 1121 972-777-6956 |
| Advanced Neuro Research Center - El Paso | El Paso | Texas | 79912-1743 | Aamr Herekar, Site 1208 915-974-2200 |
| Local Institution - 1262 | Fort Worth | Texas | 76104-4143 | Site 1262 |
| Local Institution - 1261 | Houston | Texas | 77030-1312 | Site 1261 |
| AIM Trials | Plano | Texas | 75093-8225 | Sejal Mehta, Site 1238 972-267-1988 |
| Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases | San Antonio | Texas | 78229-3901 | Antonio Teixeira, Site 1210 210-567-8229 |
| Local Institution - 1134 | Stafford | Texas | 77477-3929 | - |
| Conquest Research, LLC - Virginia - Vienna | Vienna | Virginia | 22182 | Henry Tran, Site 1241 703-717-7755 |
| Local Institution - 1253 | Bellevue | Washington | 98007-4879 | Site 1253 |
| Local Institution - 1254 | Kirkland | Washington | 98034 | - |
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