A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06937229
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
  • KarX-EC — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Key Dates

Start date
Dec 2, 2025
Status verified
Jun 2026
Primary completion
Jun 22, 2029
Completion
Jul 20, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT+KarX-EC

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately Week 30 ]

Central Contacts

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

Locations (48)

FacilityCityStateZIPSite coordinators
Local Institution - 2609ChandlerArizona85224
Site 2609
Imaging EndpointsScottsdaleArizona85258
Nida Laurin, Site 1619
480-290-1547
Local Institution - 1657AnaheimCalifornia92805
Site 1657
Local Institution - 2620Canoga ParkCalifornia91303
Site 2620
Local Institution - 1637La JollaCalifornia92037
Site 1637
Local Institution - 2607Long BeachCalifornia90805
Site 2607
Local Institution - 2625Long BeachCalifornia90040
Site 2625
Local Institution - 2642Long BeachCalifornia90807
Site 2642
Local Institution - 2613PasadenaCalifornia91105
Site 2613
Local Institution - 1662PomonaCalifornia91767
Site 1662
Local Institution - 1639TorranceCalifornia90505
Site 1639
Local Institution - 1651Walnut CreekCalifornia94596
Site 1651
Local Institution - 2602Bonita SpringsFlorida34134-4154
Site 2602
Local Institution - 2626HialeahFlorida33012
Site 2626
Local Institution - 1602MiamiFlorida33122
Site 1602
Local Institution - 1618MiamiFlorida33135
Site 1618
Nuovida Research CenterMiamiFlorida33186
Jorge Betancourt, MD, Site 1604
786-616-9853
Local Institution - 1635OrlandoFlorida32807
Site 1635
Progressive Medical ResearchPort OrangeFlorida32127
Alexander White, Site 1612
386-304-7070
IPTB Clinical ResearchTampaFlorida33629
Jamie Fernandez, Site 2621
813-251-1800
Hope Research Network - MiamiVirginia GardensFlorida33166
Jorge Jorge, Site 1609
786-681-4959
Local Institution - 2611AtlantaGeorgia30328
Site 2611
Local Institution - 1636GaithersburgMaryland20877
Site 1636
Boston Center for MemoryNewtonMassachusetts02459
Paul Solomon, Site 1638
413-281-0577
Local Institution - 2615WorcesterMassachusetts01608
Site 2615
Local Institution - 2618Ann ArborMichigan48105
Site 2618
Local Institution - 1620TroyMichigan48085
Site 1620
Local Institution - 2256Saint PaulMinnesota55130
Site 2256
Local Institution - 2629HattiesburgMississippi39402
Site 2629
Local Institution - 2628Las VegasNevada89030
Site 2628
Redbird ResearchLas VegasNevada89119
Jelena Kunovac, Site 1649
760-758-2222
Local Institution - 1647West Long BranchNew Jersey07764
Site 1647
Local Institution - 1656New WindsorNew York12553
Site 1656
Local Institution - 2619Staten IslandNew York10312
Site 2619
Local Institution - 1658WoodmereNew York11598-1739
Site 1658
West Clinical ResearchMorehead CityNorth Carolina28557
Patrick Morgante, Site 2608
252-515-0050
Local Institution - 2617Blue AshOhio45242
Site 2617
Local Institution - 1640TulsaOklahoma74136
Site 1640
Epic Medical Research, LLC - CarroltonCarrolltonTexas75006
Andrea Brown, Site 2616
972-782-2405
Local Institution - 2605CypressTexas77065
Site 2605
Local Institution - 1643El PasoTexas79912
Site 1643
Local Institution - 2622MesquiteTexas75150
Site 2622
Local Institution - 2623San AntonioTexas78229
Site 2623
Pantheon Clinical Research, LLCBountifulUtah84010
Jackson Rhudy, Site 2612
801-200-3950
Local Institution - 1646BenningtonVermont05201-9810
Site 1646
Local Institution - 1644SeattleWashington98122
Site 1644
Local Institution - 1654SpokaneWashington99201
Site 1654
Local Institution - 2610MilwaukeeWisconsin53226
Site 2610

Find similar trials in Chandler, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Local Institution - 2609· Chandler, AZImaging Endpoints· Scottsdale, AZLocal Institution - 1657· Anaheim, CALocal Institution - 2620· Canoga Park, CALocal Institution - 1637· La Jolla, CALocal Institution - 2607· Long Beach, CA

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