A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT05511363
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 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
  • Placebo — DRUG
    Placebo Capsules

Study Details

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Key Dates

Start date
Aug 23, 2022
Status verified
Apr 2026
Primary completion
Oct 5, 2026
Completion
Oct 5, 2026

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT
    Xanomeline and Trospium Chloride Capsules
  • Placebo Comparator: Placebo
    Placebo Capsules

Primary Outcome Measure

Time from randomization to relapse during the 38-week study [ Time Frame: Week 38 ]

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 (58)

FacilityCityStateZIPSite coordinators
Local Institution - 1029HomewoodAlabama35209-6809-
Local Institution - 1044PhoenixArizona85012-2836-
Local Institution - 1033EncinoCalifornia91436-2201-
Local Institution - 1031IrvineCalifornia92612-1246-
ATP Clinical Research-302 W La Veta AveOrangeCalifornia92866
Gustavo Alva, Site 1001
949-354-5353
Local Institution - 1043PasadenaCalifornia91106-
Local Institution - 1047San MarcosCalifornia92069-3595-
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDSWalnut CreekCalifornia94596
Ira Glick, Site 1007
925-298-5147
Local Institution - 1014Colorado SpringsColorado80907-5302-
Local Institution - 1013StamfordConnecticut06905-1206-
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
Arrow Clinical TrialsDaytona BeachFlorida32117-5532
David Billmeier, Site 1023
386-278-8000
Local Institution - 1045DoralFlorida33172-2638-
Local Institution - 1024HialeahFlorida33012-5884-
Local Institution - 1046HialeahFlorida33012-5826-
Local Institution - 1052HialeahFlorida33012-
Local Institution - 1049HomesteadFlorida33032-
K2 Medical Research - MaitlandMaitlandFlorida32751-5669
Brandon Lenox, Site 1039
407-670-5833
Local Institution - 1005MiamiFlorida33125-3724-
Local Institution - 1006MiamiFlorida33173-1474-
Local Institution - 1009MiamiFlorida33155-4630-
Local Institution - 1010MiamiFlorida33137-
Local Institution - 1021MiamiFlorida33122-1335-
Local Institution - 1042MiamiFlorida33186-5882-
Local Institution - 1053MiamiFlorida33166-
Local Institution - 1054MiamiFlorida33186-4643-
Local Institution - 1111MiamiFlorida33173-
Local Institution - 1115MiamiFlorida33135-
Local Institution - 1129MiamiFlorida33165-3947-
Local Institution - 1143MiamiFlorida33145-2455-
Local Institution - 1032Miami LakesFlorida33014-5602-
Local Institution - 1026Miami SpringsFlorida33166-5260-
Local Institution - 1027OcalaFlorida34470-6657-
Local Institution - 1012PensacolaFlorida32504-8608-
Local Institution - 1008St. PetersburgFlorida33713-8844-
Local Institution - 1041TampaFlorida33607-4629-
University of South FloridaTampaFlorida33606
Mark Kindy, Site 1050
813-972-2000
Local Institution - 1040The VillagesFlorida32159-8986-
Local Institution - 1037ChicagoIllinois60623-
Local Institution - 1018ManhassetNew York11030-3816-
Local Institution - 1017New YorkNew York10032-
Local Institution - 1030New YorkNew York10016-
Local Institution - 1051New YorkNew York10032-3720-
Local Institution - 1002Staten IslandNew York10314-1607-
Local Institution - 1034Stony BrookNew York11794-0001-
Five Towns Neurology, PCWoodmereNew York11598-1739
David Steiner, Site 1025
516-239-1800
Local Institution - 1003CantonOhio44718-
Local Institution - 1016Oklahoma CityOklahoma73112-
Local Institution - 1028Oklahoma CityOklahoma73104-5007-
Local Institution - 1019AllentownPennsylvania18103-
Local Institution - 1035CharlestonSouth Carolina29425-8900-
Local Institution - 1038FranklinTennessee37067-5922-
Local Institution - 1022Flower MoundTexas75028-2011-
Local Institution - 1036FriscoTexas75034-6262-
Clinical Trial Network - 7080 Southwest FwyHoustonTexas77074-2085
Djamchid Lotfi, Site 1004
713-484-6947

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