A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT06126224
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 (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)
  • Placebo — DRUG
    Placebo capsules

Study Details

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Key Dates

Start date
Aug 28, 2023
Status verified
Jun 2026
Primary completion
Dec 9, 2026
Completion
Dec 9, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score [ Time Frame: Baseline and end of Treatment (up to 14 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 (70)

FacilityCityStateZIPSite coordinators
Local Institution - 1116ChandlerArizona85286-
Local Institution - 1044PhoenixArizona85012-2836-
Local Institution - 1104AnaheimCalifornia92805-5854-
Local Institution - 1119Canoga ParkCalifornia91303-1844-
Local Institution - 1151EncinoCalifornia91316-
Local Institution - 1142LancasterCalifornia93534-2839-
Local Institution - 1117Los AlamitosCalifornia90720-6506-
Local Institution - 1103Sherman OaksCalifornia91403-2131-
Local Institution - 1007Walnut CreekCalifornia94596-
Local Institution - 1160ApopkaFlorida32703-5835-
Local Institution - 1156ClermontFlorida34711-5190-
Local Institution - 1138Cutler BayFlorida33189-1230-
Local Institution - 1162Delray BeachFlorida33445-2581-
Local Institution - 1164DoralFlorida33122-1620-
Local Institution - 1165Fort MyersFlorida33912-4302-
Local Institution - 1107HialeahFlorida33012-3618-
Local Institution - 1120HialeahFlorida33012-4648-
Local Institution - 1140HialeahFlorida33016-1814-
Local Institution - 1155HialeahFlorida33012-3158-
Local Institution - 0150HomesteadFlorida33032-8187-
Local Institution - 1145HomesteadFlorida33032-8187-
Local Institution - 1127LargoFlorida33777-1359-
Local Institution - 1039MaitlandFlorida32751-5669-
Local Institution - 1146MaitlandFlorida32751-6138-
Local Institution - 1009MiamiFlorida33155-
Local Institution - 1105MiamiFlorida33179-2537-
Local Institution - 1108MiamiFlorida33133-4231-
Local Institution - 1109MiamiFlorida33174-2950-
Local Institution - 1111MiamiFlorida33126-5683-
Local Institution - 1113MiamiFlorida33155-6630-
Local Institution - 1115MiamiFlorida33135-
Local Institution - 1118MiamiFlorida33122-1721-
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 - 1126Miami GardensFlorida33056-4000-
Local Institution - 1102Miami LakesFlorida33014-6435-
Local Institution - 1112OrlandoFlorida32807-3555-
Local Institution - 1136OrlandoFlorida32806-1041-
Local Institution - 1137Port OrangeFlorida32127-2914-
Health Synergy Clinical Research,LLC - StuartStuartFlorida34994
Mohammad Nisar, Site 1101
786-831-7303
Local Institution - 1133SweetwaterFlorida33182-
Local Institution - 1041TampaFlorida33607-4629-
Local Institution - 1110TampaFlorida33629-5837-
Local Institution - 1123TampaFlorida33614-2869-
Local Institution - 1124TampaFlorida33614-2700-
Local Institution - 1040The VillagesFlorida32159-8986-
Local Institution - 1131VieraFlorida32940
Site 1131
Local Institution - 1152AugustaGeorgia30912-0020-
Local Institution - 1141ColumbusGeorgia31909-1693-
Local Institution - 1161DecaturGeorgia30030-
Local Institution - 1148ElginIllinois60123-9215-
Local Institution - 1114MarreroLouisiana70072-3083-
Local Institution - 1139Rochester HillsMichigan48307-2760-
Local Institution - 1132FlowoodMississippi39232-
Local Institution - 1144Las VegasNevada89106-4145-
Local Institution - 1153New Hyde ParkNew York11042-2062-
Local Institution - 1135Port Jefferson StationNew York11776-3386-
Local Institution - 1122DaytonOhio45459-4248-
Local Institution - 1149MalvernPennsylvania19355-3267-
Local Institution - 1106CypressTexas77429-6070
Site 1106
Local Institution - 1163HoustonTexas77074-2085-
Local Institution - 1154KatyTexas77450-1759-
Local Institution - 1121Red OakTexas75154-
Local Institution - 1134StaffordTexas77477-3929-

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Local Institution - 1116· Chandler, AZLocal Institution - 1044· Phoenix, AZLocal Institution - 1104· Anaheim, CALocal Institution - 1119· Canoga Park, CALocal Institution - 1151· Encino, CALocal Institution - 1142· Lancaster, CA

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