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 — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified 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.com
    855-907-3286
  • First line of the email MUST contain NCT # and Site #.

Locations (98)

FacilityCityStateZIPSite coordinators
Chandler Clinical Trials, LLCChandlerArizona85224
Muhammad (Osman) Salim Khan, Site 1227
480-716-4590
Gilbert Neurology Partners - PLLC - AvacareGilbertArizona85297
Jonathan Hodgson, Site 1247
602-761-9631
Banner Alzheimer's InstitutePhoenixArizona85006-2528
Ganesh Gopalakrishna, Site 1217
602-839-6900
Scottsdale Clinical TrialsScottsdaleArizona85260-6742
Khalid Salim, Site 1220
480-382-7909
Advanced Research Center, Inc.AnaheimCalifornia92805-5854
Steven Macina, Site 1104
714-999-6688
Inland Psychiatric Medical Group (IPMG)-ChinoChinoCalifornia91710
Nandita Puchakayala, Site 1244
909-488-9116
Long Beach Research Institute, LLCLong BeachCalifornia90805
Ashley Duzik, Site 1230
562-471-3773
Local Institution - 1219Los AngelesCalifornia90095-
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)Los AngelesCalifornia90033-5313
Lon Schneider, Site 1226
323-442-3715
Local Institution - 1001OrangeCalifornia92866-
NRC Research Institute - Orange - PPDSOrangeCalifornia92868-2847
Daniel Chueh, Site 1228
714-289-1100
SC3 Research - Pasadena - 960 E. Green StPasadenaCalifornia91106
M. Lorraine Purino, Site 1043
626-250-2070
Prospective Research Innovations 8577 Haven AveRancho CucamongaCalifornia91730
Tarek Ezzeddine, Site 1213
University of Connecticut Health CenterFarmingtonConnecticut06030
Neha Jain, Site 1222
860-790-7354
Genesis Trust Research GroupAtlantisFlorida33462
Rodolfo Trejo, Site 1225
561-509-9956
Envision Trials LLCBonita SpringsFlorida34134
Daniel Mandri, Site 1020
305-819-2909
JY Research Institute IncCutler BayFlorida33189-1230
Suez Oramas Mingo, Site 1138
305-424-8696
Arrow Clinical TrialsDaytona BeachFlorida32117-5532
David Billmeier, Site 1023
386-278-8000
Quantum Laboratories, Inc - West Palm Beach OfficeDeerfield BeachFlorida33442
Jose De La Gandara, Site 1224
954-786-7331
Integrity Clinical Research LLC - 21st StreetDoralFlorida33122-1620
Lucinda Cuervo-Ramos, Site 1164
305-888-0410
Local Institution - 1264Gulf BreezeFlorida32561
Site 1264
New Life Medical Research Center -3750 W 16th AveHialeahFlorida33012-4648
Jorge Betancourt, Site 1120
305-456-7782
Research in Miami, IncHialeahFlorida33013
Dolores Sanchez Cazau, Site 1237
305-889-6670
Nexus Clinical Research Center- NRCHomesteadFlorida33030
John Cintron, Site 1229
K2 Medical Research - Lady LakeLady LakeFlorida32159
Craig Curtis, Site 1040
407-426-9299
A & D Doctor CenterMiamiFlorida33135-2968
Yordan Orive Gomez, Site 1236
305-223-2000
Dade Research Center - Miami FL - 7600 SW 87th AveMiamiFlorida33173
Maria Nualart, Site 1111
208-346-8900
Floridian Neuroscience Institute-1901 SW 1 StMiamiFlorida33135
Emilio Mantero-Atienza, Site 1115
305-326-0776
Future Care Solution LLCMiamiFlorida33165-3947
Pilar Trueba, Site 1129
305-888-0410
High Quality ResearchMiamiFlorida33184-1412
Jorge Gonzalez, Site 1157
305-392-0244
Homestead Associates in Research IncMiamiFlorida33032
Angel Carrasco, Site 1159
786-422-7374
IMIC LLC- 9380 SW 150th StrMiamiFlorida33176-7947
Leon Ramon, Site 1147
786-600-7005
Local Institution - 1105MiamiFlorida33179-2537-
Local Institution - 1143MiamiFlorida33145-2455-
Local Institution - 1158MiamiFlorida33175-
Miami Jewish Health SystemsMiamiFlorida33137
Marc Agronin, Site 1010
3057518626x2403
My Community Research Center, Inc - 7480 Bird RdMiamiFlorida33155-6630
Cesar Guerrero, Site 1113
786-359-4867
New Gen HealthMiamiFlorida33176
Roberto Hernando, Site 1234
305-892-1035
Novel Clinical Research Center, LLC.MiamiFlorida33173-1474
Heber Varela, Site 1006
000-000-0000
Premier Clinical Research InstituteMiamiFlorida33122-1335
Emelina Arocha, Site 1021
305-445-5994
Reliant Medical ResearchMiamiFlorida33165
Carlos Ramirez Calderon, Site 1150
786-801-0912
Serenity Research CenterMiamiFlorida33176-1451
Sergio Jaramillo, Site 1235
305-596-2080
Wellness Research Center Inc - MiamiMiamiFlorida33135-1601
Brian Villa, Site 1125
786-238-7099
New Med ResearchMiami GardensFlorida33056-4000
Marta Fernandez, Site 1126
305-269-7100
Angels Clinical Research Institute - Miami Lakes - Palm Springs - PPDSMiami LakesFlorida33016
Yanely Pineiro Puebla, Site 1118
786-218-1733
Panax Clinical ResearchMiami LakesFlorida33014
Robert Perry, Site 1209
305-698-4500
Aqualane Clinical ResearchNaplesFlorida34105
William Justiz, Site 1246
941-436-6838
Sensible HealthCare, LLCOcoeeFlorida34761-2964
Kelly Taylor, Site 1212
407-654-2724
Combined Research Orlando Phase I-IV LLCOrlandoFlorida32807-3555
Eric Carbonell, Site 1112
407-440-4493
Local Institution - 1257OrlandoFlorida32803
Site 1257
Nova PsychiatryOrlandoFlorida32803
David Medina, Site 1242
407-823-8421
Neurology Associates of Ormond BeachOrmond BeachFlorida32174-3101
David McDonald, Site 1204
386-673-2500
Progressive Medical Research (Duplicate)Port OrangeFlorida32127
Alexander White, Site 1205
386-304-7070
Cordova Research Institute- SweetwaterSweetwaterFlorida33182
Delores Macksoud, Site 1133
786-631-3890
Angels Clinical Research Institute Tampa - Palm Springs - PPDSTampaFlorida33614-2869
Al Robaina, Site 1123
813-931-0128
Guardian Angel ResearchTampaFlorida33614
Sadaf Bazargan, Site 1124
813-300-3300
Interventional Psychiatry of Tampa BayTampaFlorida33629-5837
Jamie Fernandez, Site 1110
813-251-1800
Local Institution - 1256The VillagesFlorida32162-2698
Site 1256
Local Institution - 1233WellingtonFlorida33414-
Premiere Research Institute at Palm Beach Neurology, PAWest Palm BeachFlorida33407-3209
Paul Winner, Site 1216
561-845-0500
Agile Clinical Research Trials, LLCAtlantaGeorgia30328-5532
Vasundhara Cheekati, Site 1206
404-382-8660
McLean HospitalBelmontMassachusetts02478-1064
Arkadiy Stolyar, Site 1223
617-855-2136
Tufts Medical Center - 800 Washington St - PPDSBostonMassachusetts02111-1552
Brent Forester, Site 1245
617-636-3202
Boston Neuro Research CenterNorth DartmouthMassachusetts02747-2612
Mushtaque Chachar, Site 1243
508-925-7403
Local Institution - 1250South DartmouthMassachusetts02747
Site 1250
Elixia Health - Springfield - Elixia - PPDSSpringfieldMassachusetts01103
Susan Smiga, Site 1239
413-305-1142
Neurobehavioral Medicine Group (NBMG)Bloomfield TownshipMichigan48302-1909
Richard Jackson, Site 1248
412-916-2425
Precise Research CentersFlowoodMississippi39232
Joseph Kwentus, Site 1132
601-420-5810
Local Institution - 1255St LouisMissouri63128
Site 1255
Advanced Memory Research Institute - CenExel - PPDSToms RiverNew Jersey08755
Arun Singh, Site 1202
732-341-9500
Bio Behavioral HealthToms RiverNew Jersey08755
Ashok Patel, Site 1232
732-244-2299
Local Institution - 1251New WindsorNew York12553-7754
Site 1251
Local Institution - 1231SyracuseNew York13203-
Local Institution - 1240SyracuseNew York13210-2306
Site 1240
Five Towns Neurology, PCWoodmereNew York11598-1739
David Steiner, Site 1025
516-239-1800
Triad Clinical Trials - 515 College RdGreensboroNorth Carolina27410-3311
Richard Montgomery, Site 1221
336-235-0991
AMC Research, LLC - Flourish - PPDSMatthewsNorth Carolina28105-8336
Mohammad Bolouri, Site 1214
704-364-4000
Local Institution - 5005Morehead CityNorth Carolina28557-
West Clinical ResearchMorehead CityNorth Carolina28557
Patrick Morgante, Site 1215
252-515-0050
Local Institution - 1252ShelbyNorth Carolina28150-3803
Site 1252
Ohio State UniversityColumbusOhio43221
Douglas Scharre, Site 1201
614-293-4560
Local Institution - 1258DaytonOhio45417-3445
Site 1258
Insight Clinical Trials LLC - IndependenceIndependenceOhio44131
Mark Stillman, Site 1249
216-444-8897
The Rivus Wellness & Research InstituteOklahoma CityOklahoma73112
Marvin Peyton, Site 1016
405-317-5783
Alzheimer's Disease and Memory Disorders Center at Rhode Island HospitalProvidenceRhode Island02903
Chuang-Kuo Wu, Site 1218
714-456-7002
Vanderbilt Psychiatric HospitalNashvilleTennessee37212-3133
Jo Wilson, Site 1211
615-322-4967
Local Institution - 1263AustinTexas78757-7566
Site 1263
Local Institution - 1260DallasTexas75231-6079
Site 1260
Epic Medical Research LLC - DeSoto - HyperCore - PPDSDeSotoTexas75115-2043
Haresh Boghara, Site 1121
972-777-6956
Advanced Neuro Research Center - El PasoEl PasoTexas79912-1743
Aamr Herekar, Site 1208
915-974-2200
Local Institution - 1262Fort WorthTexas76104-4143
Site 1262
Local Institution - 1261HoustonTexas77030-1312
Site 1261
AIM TrialsPlanoTexas75093-8225
Sejal Mehta, Site 1238
972-267-1988
Glenn Biggs Institute for Alzheimer's & Neurodegenerative DiseasesSan AntonioTexas78229-3901
Antonio Teixeira, Site 1210
210-567-8229
Local Institution - 1134StaffordTexas77477-3929-
Conquest Research, LLC - Virginia - ViennaViennaVirginia22182
Henry Tran, Site 1241
703-717-7755
Local Institution - 1253BellevueWashington98007-4879
Site 1253
Local Institution - 1254KirklandWashington98034-

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