A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07011745
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Xanomeline/Trospium Chloride Capsule — DRUG
    Specified dose on specified days
  • Xanomeline Enteric Capsule — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Key Dates

Start date
Jul 16, 2025
Status verified
Jun 2026
Primary completion
Nov 3, 2028
Completion
Nov 13, 2028

Study Design

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

Arms

  • Experimental: KarXT + KarX-EC
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14 [ Time Frame: At 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 (39)

FacilityCityStateZIPSite coordinators
Chandler Clinical Trials, LLCChandlerArizona85224
Ari Magill, Site 2609
480-382-7909
Local Institution - 2631ChandlerArizona85226-3732
Site 2631
Local Institution - 2646ChandlerArizona85286
Site 2646
National Institute of Clinical ResearchGarden GroveCalifornia92844
Michael Dao, Site 2625
AccellacareLong BeachCalifornia90807
Elizabeth Zarate Rowell, Site 2642
Local Institution - 2607Long BeachCalifornia90805
Site 2607
Local Institution - 2627NapaCalifornia94558
Site 2627
Local Institution - 2613PasadenaCalifornia91105
Site 2613
Local Institution - 2614San DiegoCalifornia92108
Site 2614
Local Institution - 2620West HillsCalifornia91307-
Local Institution - 2601BasaltColorado81621-
Local Institution - 2635Colorado SpringsColorado80907
Site 2635
Local Institution - 2632NorwalkConnecticut06851
Site 2632
Envision Trials LLCBonita SpringsFlorida34134-4154
Daniel Mandri, Site 2602
305-819-2909
Key Clinical ResearchBradentonFlorida34207
Nicholas Weber, Site 2624
+61736460818
Local Institution - 2636DoralFlorida33122
Site 2636
Local Institution - 2606HomesteadFlorida33032
Site 2606
Local Institution - 2633MiamiFlorida33137
Site 2633
Local Institution - 2637MiamiFlorida33165
Site 2637
Local Institution - 2634OrlandoFlorida32806
Site 2634
IPTB Clinical ResearchTampaFlorida33629
Jamie Fernandez, Site 2621
813-251-1800
Agile Clinical Research Trials, LLCAtlantaGeorgia30328
Vasundhara Cheekati, Site 2611
404-382-8660
Vitalix ClinicalWorcesterMassachusetts01608
James Carroll, Site 2615
413-214-3546
Michigan Clinical Research Institute PCAnn ArborMichigan48105
Ravi Kirbat, Site 2618
734-834-8954
Local Institution - 2630Saint PaulMinnesota55130
Site 2630
Hattiesburg ClinicHattiesburgMississippi39402
Ronald Schwartz, Site 2629
601-606-0911
Local Institution - 2603OzarkMissouri65721-
Las Vegas Clinical TrialsLas VegasNevada89030
Alton Walters, Site 2628
702-637-3223
Richmond Behavioral AssociatesStaten IslandNew York10312
Romana Kulikova, Site 2619
718-619-4403
Local Institution - 2644Valley StreamNew York11580
Site 2644
West Clinical ResearchMorehead CityNorth Carolina28557
Patrick Morgante, Site 2608
252-515-0050
Velocity Clinical Research - Blue AshBlue AshOhio45242
Babu Gupta, Site 2617
513-769-2767
Epic Medical Research, LLC - CarroltonCarrolltonTexas75006
Andrea Brown, Site 2616
972-782-2405
Horizon Clinical Research Center - HoustonCypressTexas77065
Harpaul Gill, Site 2605
770-205-5292
Epic Medical Research, LLC - MesquiteMesquiteTexas75150
Laquita Shepherd, Site 2622
972-777-6956
UT Health - San AntonioSan AntonioTexas78229
Antonio Teixeira, Site 2623
210-567-8229
Local Institution - 2612BountifulUtah84010-
EvergreenHealth Medical CenterKirklandWashington98034
Pinky Agarwal, Site 2638
425-899-3123
Local Institution - 2610MilwaukeeWisconsin53226
Site 2610

Find similar trials in Chandler, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Chandler Clinical Trials, LLC· Chandler, AZLocal Institution - 2631· Chandler, AZLocal Institution - 2646· Chandler, AZNational Institute of Clinical Research· Garden Grove, CAAccellacare· Long Beach, CALocal Institution - 2607· Long Beach, CA

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