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
Apply to this trial

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

First listed
Sep 19, 2024
Start date
Sep 26, 2024
Status verified
Jul 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
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (99)

FacilityCityStateZIPSite coordinators
Local Institution - 1227ChandlerArizona85224-
Gilbert Neurology Partners - PLLC - AvacareGilbertArizona85297
Jonathan Hodgson, Site 1247
602-761-9631
Banner Alzheimer's InstitutePhoenixArizona85006-2528
Ganesh Gopalakrishna, Site 1217
602-839-6900
Local Institution - 1220ScottsdaleArizona85260-6742-
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
Local Institution - 1230Long BeachCalifornia90805-
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-
Local Institution - 1228OrangeCalifornia92868-2847-
Local Institution - 1043PasadenaCalifornia91106-
Local Institution - 1213Rancho CucamongaCalifornia91730-
University of Connecticut Health CenterFarmingtonConnecticut06030
Neha Jain, Site 1222
860-790-7354
Local Institution - 1225AtlantisFlorida33462-
Envision Trials LLCBonita SpringsFlorida34134
Daniel Mandri, Site 1020
305-819-2909
Local Institution - 1138Cutler BayFlorida33189-1230-
Arrow Clinical TrialsDaytona BeachFlorida32117-5532
David Billmeier, Site 1023
386-278-8000
Local Institution - 1224Deerfield BeachFlorida33442-
Local Institution - 1164DoralFlorida33122-1620-
Local Institution - 1264Gulf BreezeFlorida32561
Site 1264
Local Institution - 1120HialeahFlorida33012-4648-
Local Institution - 1237HialeahFlorida33013-
Local Institution - 1229HomesteadFlorida33030-
Local Institution - 1040Lady LakeFlorida32159-
Local Institution - 1006MiamiFlorida33173-1474-
Local Institution - 1010MiamiFlorida33137-
Local Institution - 1021MiamiFlorida33122-1335-
Local Institution - 1105MiamiFlorida33179-2537-
Local Institution - 1111MiamiFlorida33173-
Local Institution - 1113MiamiFlorida33155-6630-
Local Institution - 1115MiamiFlorida33135-
Local Institution - 1125MiamiFlorida33135-1601-
Local Institution - 1129MiamiFlorida33165-3947-
Local Institution - 1143MiamiFlorida33145-2455-
Local Institution - 1147MiamiFlorida33176-7947-
Local Institution - 1150MiamiFlorida33165-
Local Institution - 1157MiamiFlorida33184-1412-
Local Institution - 1158MiamiFlorida33175-
Local Institution - 1159MiamiFlorida33032-
Local Institution - 1234MiamiFlorida33176-
Local Institution - 1235MiamiFlorida33176-1451-
Local Institution - 1236MiamiFlorida33135-2968-
Local Institution - 1126Miami GardensFlorida33056-4000-
Local Institution - 1118Miami LakesFlorida33016-
Local Institution - 1209Miami LakesFlorida33014-
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
Local Institution - 1204Ormond BeachFlorida32174-3101-
Local Institution - 1205Port OrangeFlorida32127-5169-
Local Institution - 1133SweetwaterFlorida33182-
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 - 1123TampaFlorida33614-2869-
Charter ResearchThe VillagesFlorida32162-2698
Jeffrey Norton, Site 1256
352-775-1000
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-
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
Local Institution - 1232Toms RiverNew Jersey08755-
Mid Hudson Medical Research PLLCNew WindsorNew York12553-7754
Sashi Makam, Site 1251
845-674-9398
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-
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
Local Institution - 1259IrvingTexas75062-2898
Site 1259
Local Institution - 1238PlanoTexas75093-8225-
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
Northwest Clinical Research CenterBellevueWashington98007-4879
Wisam Al Jumaili, Site 1253
425-453-0404
Local Institution - 1254KirklandWashington98034-

Find similar trials in Chandler, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Local Institution - 1227· Chandler, AZGilbert Neurology Partners - PLLC - Avacare· Gilbert, AZBanner Alzheimer's Institute· Phoenix, AZLocal Institution - 1220· Scottsdale, AZAdvanced Research Center, Inc.· Anaheim, CAInland Psychiatric Medical Group (IPMG)-Chino· Chino, CA

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