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

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

Study Design

Enrollment
650 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 - 2649OrangeCalifornia92866
Site 2649
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 - 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 - 1664PrincetonNew Jersey08540
Site 1664
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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