Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT05980949
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Psychosis Associated With Alzheimer's Disease

Eligibility Criteria

Sex
ALL
Age
55 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • KarXT — DRUG
    KarXT 20/2 mg TID (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)

Study Details

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Key Dates

Start date
Jul 11, 2023
Status verified
Jun 2026
Primary completion
Sep 7, 2027
Completion
Sep 7, 2027

Study Design

Enrollment
800 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT
    Xanomeline and Trospium Chloride Capsules

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From initial dose through 14 days after the final dose (up to 54 weeks) ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (147)

FacilityCityStateZIPSite coordinators
Local Institution - 1029HomewoodAlabama35209-6809-
Local Institution - 1-13H98LK9ChandlerArizona85224-6231-
Local Institution - 1116ChandlerArizona85286-
Local Institution - 1227ChandlerArizona85224-
Local Institution - 1247GilbertArizona85297
Site 1247
Local Institution - 1044PhoenixArizona85012-2836-
Local Institution - 1217PhoenixArizona85006-2528
Site 1217
Local Institution - 1220ScottsdaleArizona85260-6742-
Advanced Research Center, Inc.AnaheimCalifornia92805-5854
Steven Macina, Site 1104
714-999-6688
Local Institution - 1-141NO1DGChinoCalifornia91710
Site 1-141NO1DG
Local Institution - 1001Costa MesaCalifornia92626-
Local Institution - 1033EncinoCalifornia91436-2201-
Local Institution - 1151EncinoCalifornia91316-
Local Institution - 1031IrvineCalifornia92612-1246-
Local Institution - 1230LakewoodCalifornia90805-4549
Site 1230
Local Institution - 1142LancasterCalifornia93534-2839-
Local Institution - 1117Los AlamitosCalifornia90720-6506-
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)Los AngelesCalifornia90033-5313
Lon Schneider, Site 1226
323-442-3715
Local Institution - 1228OrangeCalifornia92868-2847
Site 1228
SC3 Research - Pasadena - 960 E. Green StPasadenaCalifornia91106
M. Lorraine Purino, Site 1043
626-250-2070
Local Institution - 1213Rancho CucamongaCalifornia91730
Site 1213
Local Institution - 1103Sherman OaksCalifornia91403-2131-
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDSWalnut CreekCalifornia94596
Ira Glick, Site 1007
925-298-5147
Local Institution - 1014Colorado SpringsColorado80907-5302-
University of Connecticut Health CenterFarmingtonConnecticut06030
Neha Jain, Site 1222
860-790-7354
Local Institution - 1013StamfordConnecticut06905-1206-
Local Institution - 1225AtlantisFlorida33462-
Local Institution - 1011Boca RatonFlorida33487-2768-
Envision Trials LLCBonita SpringsFlorida34134
Daniel Mandri, Site 1020
305-819-2909
Local Institution - 1015BradentonFlorida34209-4687-
K2 Medical Research - Winter GardenClermontFlorida34711-5933
Christopher Galloway, Site 1048
321-500-5252
Local Institution - 1156ClermontFlorida34711-5190-
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
Local Institution - 1224Deerfield BeachFlorida33442-
Local Institution - 1162Delray BeachFlorida33445-2581-
Betancourt Research ServicesDoralFlorida33172-2638
Beatriz Triana, Site 1045
786-741-2287
Integrity Clinical Research LLC - 21st StreetDoralFlorida33122-1620
Lucinda Cuervo-Ramos, Site 1164
305-888-0410
Local Institution - 1165Fort MyersFlorida33912-4302-
Direct Helpers Research CenterHialeahFlorida33012-3618
Manuel Fernandez, Site 1107
305-828-3555
Galiz ResearchHialeahFlorida33016-1814
Jose Gamez, Site 1140
305-805-0921
Las Mercedes Medical Research - 4440 West 16th AveHialeahFlorida33012
Frank Carlos Alvarez Li, Site 1052
786-334-6675
Local Institution - 1-13JED81KHialeahFlorida33013-
Local Institution - 1046HialeahFlorida33012-5826
Site 1046
Local Institution - 1155HialeahFlorida33012-3158-
Local Institution - 1237HialeahFlorida33013-
New Life Medical Research Center -3750 W 16th AveHialeahFlorida33012-4648
Jorge Betancourt, Site 1120
305-456-7782
Coral Clinic ResearchHomesteadFlorida33032
Nelson Gonzalez, Site 1049
786-715-2200
Homestead Associates in Research Inc-30328 Old Dixie HwyHomesteadFlorida33033
Angel Carrasco, Site 1159
786-422-7374
Local Institution - 1145HomesteadFlorida33032-8187-
Nexus Clinical Research Center- NRCHomesteadFlorida33030
John Cintron, Site 1229
Local Institution - 1127LargoFlorida33777-1359-
K2 Medical Research - MaitlandMaitlandFlorida32751-5669
Brandon Lenox, Site 1039
407-670-5833
Local Institution - 1146MaitlandFlorida32751-6138-
A & D Doctor CenterMiamiFlorida33135-2968
Yordan Orive Gomez, Site 1236
305-223-2000
Allied Biomedical Research InstituteMiamiFlorida33155-4630
Michael Pfeffer, Site 1009
866-879-2507
Angels Clinical Research Institute - MiamiMiamiFlorida33122-1721
Yanely Pineiro Puebla, Site 1118
786-218-1733
CCM Clinical Research GroupMiamiFlorida33133-4231
Francisco Ricart, Site 1108
208-346-8900
Coral Research Clinic & Coral Diagnostic CenterMiamiFlorida33186-4643
Jorge Paoli Bruno, Site 1054
000-000-0000
Dade Research Center - Miami FL - 7600 SW 87th AveMiamiFlorida33173
Maria Nualart, Site 1111
305-263-7120
Florida Research Center, Inc.MiamiFlorida33174-2950
Sonia Rente, Site 1109
305-551-8493
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
IMIC LLC- 9380 SW 150th StrMiamiFlorida33176-7947
Leon Ramon, Site 1147
786-600-7005
Local Institution - 1005MiamiFlorida33125-3724
Site 1005
Local Institution - 1010MiamiFlorida33137-
Local Institution - 1105MiamiFlorida33179-2537-
Local Institution - 1158MiamiFlorida33175-
MedOne Clinical Research LLCMiamiFlorida33145-2455
Thierry Jacquemin, Site 1143
305-359-7666
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 -7000 SW 97th AveMiamiFlorida33173-1474
Heber Varela, Site 1006
000-000-0000
ONHEALTH Research CenterMiamiFlorida33186-5882
Maria Rodil, Site 1042
786-808-0832
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
South Florida Research Phase I-IV, Inc. - MiamiMiamiFlorida33166
Silvia Silva Duluc, Site 1053
305-669-6166
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
Local Institution - 1209Miami LakesFlorida33014-
Meridian International ResearchMiami LakesFlorida33014-6435
Gonzalo Quesada, Site 1102
305-705-4494
San Marcus Research Clinic IncMiami LakesFlorida33014-5602
Nancy Navarro Gonzalez, Site 1032
Ocean Blue Medical Research Center IncMiami SpringsFlorida33166-5260
Antonio Terrelonge, Site 1026
305-885-8983
Local Institution - 1246NaplesFlorida34105
Site 1246
Local Institution - 1212OcoeeFlorida34761-2964
Site 1212
Local Institution - 1101OkeechobeeFlorida34972-2568-
Combined Research Orlando Phase I-IV LLCOrlandoFlorida32807-3555
Eric Carbonell, Site 1112
407-440-4493
Local Institution - 1136OrlandoFlorida32806-1041-
Nova PsychiatryOrlandoFlorida32803
David Medina, Site 1242
407-823-8421
Neurology Associates of Ormond BeachOrmond BeachFlorida32174-3101
David McDonald, Site 1204
386-673-2500
Local Institution - 1012PensacolaFlorida32504-8608-
Local Institution - 1137Port OrangeFlorida32127-2914-
Local Institution - 1205Port OrangeFlorida32127-
Local Institution - 1008St. PetersburgFlorida33713-8844-
Local Institution - 1133SweetwaterFlorida33182-
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 - 1041TampaFlorida33607-4629
Site 1041
Local Institution - 1040The VillagesFlorida32159-8955
Site 1040
Local Institution - 1131VieraFlorida32940-
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
Local Institution - 1161DecaturGeorgia30030-
Local Institution - 1037BerwynIllinois60402-2173-
Local Institution - 1148ElginIllinois60123-9215-
Local Institution - 1114MarreroLouisiana70072-3083-
Local Institution - 1223BelmontMassachusetts02478-1064
Site 1223
Local Institution - 1245BostonMassachusetts02111-1552
Site 1245
Local Institution - 1243North DartmouthMassachusetts02747-2612
Site 1243
Local Institution - 1239SpringfieldMassachusetts01103
Site 1239
Local Institution - 1-146Y4PVYBloomfield TownshipMichigan48302-1909-
Local Institution - 1248Bloomfield TownshipMichigan48302-1909
Site 1248
Local Institution - 1139Rochester HillsMichigan48307-2760-
Precise Research CentersFlowoodMississippi39232
Joseph Kwentus, Site 1132
601-420-5810
Local Institution - 1255St LouisMissouri63128
Site 1255
Local Institution - 1202Toms RiverNew Jersey08755
Site 1202
Local Institution - 1232Toms RiverNew Jersey08755-
Local Institution - 1018ManhassetNew York11030-3816-
Local Institution - 1017New YorkNew York10032-
Local Institution - 1034Stony BrookNew York11794-0001-
Local Institution - 1231SyracuseNew York13203-
Local Institution - 1240SyracuseNew York13210-1718
Site 1240
Five Towns Neurology PC -Woodmere - 923 BroadwayWoodmereNew York11598-1739
David Steiner, Site 1025
516-239-1800
Local Institution - 1221GreensboroNorth Carolina27410-3311
Site 1221
AMC Research, LLC - Flourish - PPDSMatthewsNorth Carolina28105-8336
Mohammad Bolouri, Site 1214
704-364-4000
Local Institution - 1215Morehead CityNorth Carolina28557
Site 1215
Local Institution - 1252ShelbyNorth Carolina28150-3803
Site 1252
Local Institution - 1201ColumbusOhio43210
Site 1201
Local Institution - 1122DaytonOhio45459-4248-
Local Institution - 1249Shaker HeightsOhio44122-5288
Site 1249
Local Institution - 1016Oklahoma CityOklahoma73112
Site 1016
Local Institution - 1218ProvidenceRhode Island02903-
Local Institution - 1035CharlestonSouth Carolina29425-8900-
Local Institution - 1211NashvilleTennessee37212-3133
Site 1211
Horizon Clinical Research: Gill NeuroscienceCypressTexas77429-6070
Harpaul Gill, Site 1106
949-491-0710
Local Institution - 1121DeSotoTexas75115-2043
Site 1121
Local Institution - 1208El PasoTexas79912-1743
Site 1208
Local Institution - 1022Flower MoundTexas75028-2011-
Local Institution - 1036FriscoTexas75034-6262-
Clinical Trial Network - 7080 Southwest FwyHoustonTexas77074-2085
Djamchid Lotfi, Site 1004
713-484-6947
Local Institution - 1238PlanoTexas75093-8225
Site 1238
Local Institution - 1210San AntonioTexas78229-3901
Site 1210
Local Institution - 1134StaffordTexas77477-3929-
Local Institution - 1241ArlingtonVirginia22205
Site 1241
Local Institution - 1254KirklandWashington98034-3030
Site 1254

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