A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT05463731
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Remternetug (IV) — DRUG
    Administered IV
  • Remternetug (SC) — DRUG
    Administered SC
  • Placebo — DRUG
    Administered IV or SC

Study Details

The reason for this study is to collect safety and efficacy information regarding the study drug remternetug in participants with early symptomatic Alzheimer's disease (AD).

Key Dates

First listed
Jul 19, 2022
Start date
Aug 1, 2022
Status verified
May 2026
Primary completion
Apr 24, 2024
Completion
May 12, 2026

Study Design

Enrollment
1,667 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remternetug (IV)
    Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
  • Experimental: Remternetug (SC)
    Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
  • Placebo Comparator: Placebo
    Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
  • Experimental: Open-Label Addenda Remternetug (IV)
    Participants will receive one of six dosing regimens of remternetug IV during the open-label addenda.
  • Experimental: Open-Label Addenda Remternetug (SC)
    Participants will receive one of nine dosing regimens of remternetug SC during the open-label addenda.

Primary Outcome Measure

Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Week 52 ]

Locations (73)

FacilityCityStateZIPSite coordinators
MD First Research - ChandlerChandlerArizona85286-
Hope Clinical Research, Inc.Canoga ParkCalifornia91303-
North County Neurology AssociatesCarlsbadCalifornia92011-
Wr- Pri, LlcEncinoCalifornia91316-
Neuro-Pain Medical CenterFresnoCalifornia93710-
Irvine Clinical ResearchIrvineCalifornia92614-
Kaizen Brain CenterLa JollaCalifornia92037-
Anderson Clinical ResearchRedlandsCalifornia92374-
Mountain Neurological Research CenterBasaltColorado81621-
Alpine Clinical Research CenterBoulderColorado80301-
Colorado Springs Neurological AssociatesColorado SpringsColorado80907-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamfordConnecticut06905-
JEM Research InstituteAtlantisFlorida33462-
VIN-Julie SchwartzbardAventuraFlorida33180-
Brain Matters ResearchDelray BeachFlorida33445-
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912-
Finlay Medical ResearchGreenacres CityFlorida33467-
Encore Research Group- Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
ClinCloud - MaitlandMaitlandFlorida32751-
K2 Medical ResearchMaitlandFlorida32751-
ClinCloud - VieraMelbourneFlorida32940-
Merritt Island Medical Research, LLCMerritt IslandFlorida32952-
Optimus U CorporationMiamiFlorida33135-
VIN-Andrew LermanMiamiFlorida33133-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Renstar Medical ResearchOcalaFlorida34470-
Charter Research - Winter ParkOrlandoFlorida32803-
Emerald Coast Neurology - Airport BoulevardPensacolaFlorida32504-
Progressive Medical ResearchPort OrangeFlorida32127-
Alzheimer's Research and Treatment CenterStuartFlorida34997-
Brain Matters ResearchStuartFlorida34997-
Tallahassee Neurological ClinicTallahasseeFlorida32308-
Charter Research - Lady LakeThe VillagesFlorida32162-
Alzheimer's Research and Treatment CenterWellingtonFlorida33414-
Palm Beach NeurologyWest Palm BeachFlorida33407-
Conquest ResearchWinter ParkFlorida32789-
Columbus Memory Center, PCColumbusGeorgia31909-
iResearch AtlantaDecaturGeorgia30030-
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640-
AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchElk Grove VillageIllinois60007-
Covenant Medical CenterWaterlooIowa50702-
Cotton O'Neil Clinical Research Center - Central OfficeTopekaKansas66606-
Care Access - Lake CharlesLake CharlesLouisiana70601-
MedVadis Research CorporationWalthamMassachusetts02451-
Adams ClinicalWatertownMassachusetts02472-
Citizens Memorial Hospital DistrictBolivarMissouri65613-
Clinical Research ProfessionalsChesterfieldMissouri63005-
Las Vegas Medical ResearchLas VegasNevada89128-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
Advanced Memory Research Institute of New JerseyToms RiverNew Jersey08755-
Neurological Associates AlbanyAlbanyNew York12208-
AMC ResearchMatthewsNorth Carolina28105-
Carteret Medical GroupMorehead CityNorth Carolina28557-
NeuroScience Research CenterCantonOhio44718-
Valley Medical ResearchCentervilleOhio45459-
Neurology Diagnostics, Inc.DaytonOhio45459-
Center for Cognitive HealthPortlandOregon97225-
The Clinical Trial Center, LLCJenkintownPennsylvania19046-
Keystone Clinical StudiesPlymouth MeetingPennsylvania19462-
Rhode Island Mood & Memory Research InstituteEast ProvidenceRhode Island02914-
Neurology Clinic, P.C.CordovaTennessee38018-
Texas Diabetes & Endocrinology, P.A.AustinTexas78749-
Gadolin ResearchBeaumontTexas77702-
Kerwin Medical CenterDallasTexas75231-
Neurology Consultants of Dallas, PADallasTexas75243-
The University of Texas Health Science Center at HoustonHoustonTexas77054-
Central Texas Neurology ConsultantsRound RockTexas78681-
Consano Clinical Research, LLCShavano ParkTexas78231-
Re:Cognition HealthFairfaxVirginia22031-
National Clinical Research, IncRichmondVirginia23294-
Northwest Clinical Research CenterBellevueWashington98007-
Universal Research GroupTacomaWashington98405-

Related coverage on Hipa.ai

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Alzheimer's disease
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MD First Research - Chandler· Chandler, AZHope Clinical Research, Inc.· Canoga Park, CANorth County Neurology Associates· Carlsbad, CAWr- Pri, Llc· Encino, CANeuro-Pain Medical Center· Fresno, CAIrvine Clinical Research· Irvine, CA

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