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-1)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07011732
Phase
PHASE3
Status
Recruiting
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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 10, 2025
Status verified
Jun 2026
Primary completion
Nov 24, 2028
Completion
Dec 8, 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 (40)

FacilityCityStateZIPSite coordinators
Imaging EndpointsScottsdaleArizona85258
Nida Laurin, Site 1619
480-290-1547
Advanced Research Center (ARC) - AnaheimAnaheimCalifornia92805
Steven Macina, Site 1657
714-999-6688
Local Institution - 1637La JollaCalifornia92037-
The Neurology GroupPomonaCalifornia91767
Sadiq Altamimi, Site 1662
Torrance Clinical ResearchTorranceCalifornia90505
Marina Raikhel, Site 1639
310-373-8120
Sunwise Clinical ResearchWalnut CreekCalifornia94596
Ira Glick, Site 1651
925-298-5147
Local Institution - 1630Colorado SpringsColorado80907-
Local Institution - 1622MaitlandFlorida32751
Site 1622
Local Institution - 1631MaitlandFlorida32751
Site 1631
Local Institution - 1666Merritt IslandFlorida32952
Site 1666
Hope Research Network - MiamiMiamiFlorida33166
Jorge Jorge, Site 1609
786-681-4959
Local Institution - 1602MiamiFlorida33122
Site 1602
Local Institution - 1604MiamiFlorida33186-
Local Institution - 1618MiamiFlorida33135
Site 1618
Local Institution - 1608OcalaFlorida34471
Site 1608
Combined Research Orlando (CRO)OrlandoFlorida32807
Eric Carbonell, Site 1635
407-440-4493
Progressive Medical ResearchPort OrangeFlorida32127
Alexander White, Site 1612
386-304-7070
Local Institution - 1655MarreroLouisiana70072
Site 1655
CBH HealthGaithersburgMaryland20877
Elia Acevedo Diaz, Site 1636
301-251-4702
Local Institution - 1663FoxboroughMassachusetts02035-1309
Site 1663
Boston Center for MemoryNewtonMassachusetts02459
Paul Solomon, Site 1638
413-281-0577
Mayflower Clinical ResearchSouth DartmouthMassachusetts02747
Mushtaque Chachar, Site 1642
508-925-7403
Elixia MASpringfieldMassachusetts01103
Brittany Perreault, Site 1660
NeuroBehavioral Medicine GroupBloomfield HillsMichigan48302
Richard Jackson, Site 1665
412-916-2425
Oakland Medical ResearchTroyMichigan48085
Jay Sandberg, Site 1620
248-687-7412
Redbird ResearchLas VegasNevada89119
Jelena Kunovac, Site 1649
760-758-2222
Patient First MDMiddletownNew Jersey07748
Matthew Davis, Site 1647
585-288-0893
Global Medical Institutes LLC; Princeton Medical InstitutePrincetonNew Jersey08540
Matthew Adasofunjo, Site 1664
Local Institution - 1610InwoodNew York11096
Site 1610
Mid Hudson Medical ResearchNew WindsorNew York12553
Sashi Makam, Site 1656
845-674-9398
Five Towns Neurology PC -Woodmere - 923 BroadwayWoodmereNew York11598-1739
David Steiner, Site 1658
516-239-1800
Local Institution - 1645WoodmereNew York11598-1739-
Local Institution - 1659CentervilleOhio45459
Site 1659
Central States ResearchTulsaOklahoma74136
Sarah Land, Site 1640
918-645-5400
Local Institution - 1652ColumbiaSouth Carolina29205-
Advanced Neurology Epilepsy and Sleep CenterEl PasoTexas79912
Aamr Herekar, Site 1643
505-903-1715
Wasatch Clinical Research, LLCSalt Lake CityUtah84107
Albert Jarvi, Site 1641
801-288-0607
The Memory ClinicBenningtonVermont05201-9810
Lisa Catapano-Friedman, Site 1646
413-281-0575
Local Institution - 1644SeattleWashington98122
Site 1644
Kingfisher CooperativeSpokaneWashington99201
David Greeley, Site 1654
509-458-7720

Find similar trials in Scottsdale, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Imaging Endpoints· Scottsdale, AZAdvanced Research Center (ARC) - Anaheim· Anaheim, CALocal Institution - 1637· La Jolla, CAThe Neurology Group· Pomona, CATorrance Clinical Research· Torrance, CASunwise Clinical Research· Walnut Creek, CA

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