A Donanemab (LY3002813) Study in Participants With Preclinical Alzheimer's Disease (TRAILBLAZER-ALZ 3)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05026866
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Donanemab — DRUG
    Administered intravenously
  • Placebo — DRUG
    Administered intravenously

Study Details

The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD) over up to 332 weeks. Approximately 800 additional participants will be enrolled in the 12-month Addendum 7 to assess safety of a different titration regimen.

Key Dates

Start date
Aug 27, 2021
Status verified
Jan 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
2,996 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab
    Donanemab administered intravenously (IV)
  • Placebo Comparator: Placebo
    Placebo is administered intravenously

Primary Outcome Measure

Time to Clinical Progression of Composite Endpoint as Measured by Clinical Dementia Rating (CDR) in the Primary Study Population (Baseline CDR-Global Score [GS 0]) [ Time Frame: Estimated up to Week 332 ]

Locations (198)

FacilityCityStateZIPSite coordinators
Parkway Medical CenterBirminghamAlabama35215-
Alabama Psychiatry - Birmingham - Brookwood Medical Center DriveHomewoodAlabama35209-
Rehabilitation & Neurological ServicesHuntsvilleAlabama35805-
Care Access - 801 South Power Road, MesaMesaArizona85206-
Banner Alzheimer's InstitutePhoenixArizona85006-
Banner Alzheimer's Institute TucsonTucsonArizona85718-
Center for NeurosciencesTucsonArizona85718-
Care Access - BerkeleyBerkeleyCalifornia94705-
Care Access - Beverly HillsBeverly HillsCalifornia90212-
Velocity Clinical Research, Chula VistaChula VistaCalifornia91911-
Valley Clinical Trials, Inc.CovinaCalifornia91723-
Neurology Center of North Orange CountyFullertonCalifornia92835-
Care Access - GilroyGilroyCalifornia95020-
Care Access Research - Huntington BeachHuntington BeachCalifornia92648-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Irvine Clinical ResearchIrvineCalifornia92614-
Option Care - IrvineIrvineCalifornia92618-
Kaizen Brain CenterLa JollaCalifornia92037-
Velocity Clinical Research, San DiegoLa MesaCalifornia91942-
Pacific Research NetworkLemon GroveCalifornia91945-
Healthy Brain ClinicLong BeachCalifornia90804-
NeurovationsNapaCalifornia94558-
Care Access - Newport BeachNewport BeachCalifornia92660-
Valley Clinical Trials, Inc.NorthridgeCalifornia91325-
Anderson Clinical ResearchRedlandsCalifornia92374-
Inland Psychiatric Medical GroupRedlandsCalifornia92373-
Artemis Institute for Clinical ResearchRiversideCalifornia92503-
Option Care - RiversideRiversideCalifornia92507-
Clinical Trials ResearchSacramentoCalifornia95821-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92123-
Ray Dolby Brain Health CenterSan FranciscoCalifornia94114-
Care Access - Los GatosSan JoseCalifornia95124-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
Care Access - Santa ClaritaSanta ClaritaCalifornia91321-
Option Care - Los Angeles SouthSanta Fe SpringsCalifornia90670-
Providence Medical FoundationSanta RosaCalifornia95403-
Mazur, Statner, Dutta, Nathan, PCThousand OaksCalifornia91360-
Tilda ResearchTustinCalifornia92780-
Velocity Clinical Research, Panorama CityVan NuysCalifornia91405-
Infectious Disease Doctors Medical Group, APCWalnut CreekCalifornia94598-
Care Access - AuroraAuroraColorado80012-
Mountain Neurological Research CenterBasaltColorado81621-
Denver Neurological ResearchDenverColorado80210-
InvicroNew HavenConnecticut06510-
JEM Research InstituteAtlantisFlorida33462-
VIN-Julie SchwartzbardAventuraFlorida33180-
Excel Medical Clinical TrialsBoca RatonFlorida33434-
Neurology Offices of South FloridaBoca RatonFlorida33428-
SFM Clinical ResearchBoca RatonFlorida33487-
Bradenton Research Center, Inc.BradentonFlorida34205-
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765-
Care Access - Daytona BeachDaytona BeachFlorida32114-
Care Access - Delray BeachDelray BeachFlorida33484-
Finlay Medical ResearchGreenacres CityFlorida33467-
Indago Research & Health Center, IncHialeahFlorida33012-
Infinity Clinical Research, LLCHollywoodFlorida33024-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Care Access - Guava StreetLady LakeFlorida32159-
Accel Research Sites - St. Pete-Largo Clinical Research UnitLargoFlorida33777-
ClinCloud - MaitlandMaitlandFlorida32751-
K2 Medical ResearchMaitlandFlorida32751-
ClinCloud - VieraMelbourneFlorida32940-
Merritt Island Medical Research, LLCMerritt IslandFlorida32952-
Brainstorm Research GroupMiamiFlorida33176-
Finlay Medical ResearchMiamiFlorida33126-
IMIC, Inc.MiamiFlorida33176-
Optimus U CorporationMiamiFlorida33125-
South Florida Research Phase I-IVMiamiFlorida33166-
VIN-Andrew LermanMiamiFlorida33133-
VIN-Victor FaradjiMiamiFlorida33176-
San Marcus Research Clinic, Inc.Miami LakesFlorida33014-
Adult Medicine of Lake CountyMt. DoraFlorida32757-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Renstar Medical ResearchOcalaFlorida34470-
Charter Research - Winter ParkOrlandoFlorida32803-
Headlands Research OrlandoOrlandoFlorida32806-
Pines Care Research Center, LLCPembroke PinesFlorida33024-
VIN- Margarita Almeida El-RameyPembroke PinesFlorida33026-
Emerald Coast Neurology - Airport BoulevardPensacolaFlorida32504-
Progressive Medical ResearchPort OrangeFlorida32127-
Care Access - TamaracTamaracFlorida33321-
Care Access - TampaTampaFlorida33625-
Clinical Research of West FloridaTampaFlorida33606-
Coram CVS/Specialty Infusion Services - TampaTampaFlorida33634-
K2 Medical Research - TampaTampaFlorida33634-
Stedman Clinical TrialsTampaFlorida33613-
Vicis Clinical ResearchTampaFlorida33615-
Charter Research - Lady LakeThe VillagesFlorida32162-
Palm Beach Research CenterWest Palm BeachFlorida33409-
Conquest ResearchWinter ParkFlorida32789-
Masters of Clinical ResearchAugustaGeorgia30909-
iResearch AtlantaDecaturGeorgia30030-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Meridian Clinical Research, LLCSavannahGeorgia31406-
SKY Clinical Research Network Group-BlakeUnion CityGeorgia30291-
North Georgia Clinical ResearchWoodstockGeorgia30189-
Northwest Clinical TrialsBoiseIdaho83704-
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640-
IMA Clinical Research ChicagoChicagoIllinois60602-
Uptown Research InstituteChicagoIllinois60640-
AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchElk Grove VillageIllinois60007-
Care Access - Fairview HeightsFairview HeightsIllinois62208-
Great Lakes Clinical Trials - GurneeGurneeIllinois60031-
Accellacare - DuPageLombardIllinois60148-
Coram CVS/Specialty Infusion Services - Fort WayneFort WayneIndiana46805-
Care Access - South IndianapolisIndianapolisIndiana46227-
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256-
Covenant Medical CenterWaterlooIowa50702-
College Park Specialty CenterOverland ParkKansas66212-
Norton Brownsboro HospitalLouisvilleKentucky40241-
Optum Infusion - Baton RougeBaton RougeLouisiana70809-
Care Access - Lake CharlesLake CharlesLouisiana70601-
MD Medical ResearchOxon HillMaryland20745-
ActivMed Practices and ResearchMethuenMassachusetts01844-
Boston Center for MemoryNewtonMassachusetts02459-
Care Access - QuincyQuincyMassachusetts02169-
MedVadis Research CorporationWalthamMassachusetts02451-
Revival Research InstituteSouthfieldMichigan48075-
Minneapolis Clinic of Neurology - Burnsville OfficeBurnsvilleMinnesota55337-
Coram CVS/Specialty Infusion Services - Mendota HeightsMendota HeightsMinnesota55120-
SKY Clinical Research Network Group - HallFayetteMississippi39069-
SKY Clinical Research Network Group-QuinnRidgelandMississippi39157-
Citizens Memorial Hospital DistrictBolivarMissouri65613-
Clinical Research ProfessionalsChesterfieldMissouri63005-
IMA Clinical Research - St. LouisSt LouisMissouri63117-
Coram CVS/Specialty Infusion Services - HendersonHendersonNevada89014-
Las Vegas Medical ResearchLas VegasNevada89128-
Option Care - Las VegasLas VegasNevada89102-
IMA Clinical Research HobokenHobokenNew Jersey07030-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
IMA Clinical Research WarrenWarren TownshipNew Jersey07059-
Albuquerque Neuroscience Inc.AlbuquerqueNew Mexico87109-
IMA Clinical Research AlbanyAlbanyNew York12205-
Neurological Associates AlbanyAlbanyNew York12208-
Velocity Clinical Research, SyracuseEast SyracuseNew York13057-
IMA Clinical Research WestchesterHartsdaleNew York10530-
IMA Clinical ResearchNew YorkNew York10036-
South Shore Neurologic AssociatesPatchogueNew York11772-
Richmond Behavioral AssociatesStaten IslandNew York10314-
Prime Global ResearchThe BronxNew York10456-
Asheville Neurology SpecialistsAshevilleNorth Carolina28806-
Care Access - CharlotteCharlotteNorth Carolina28210-
Care Access - FayettevilleFayettevilleNorth Carolina28314-
Care Access - GreensboroGreensboroNorth Carolina27401-
Medication ManagementGreensboroNorth Carolina27405-
Care Access - KinstonKinstonNorth Carolina28501-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Carteret Medical GroupMorehead CityNorth Carolina28557-
Care Access - RaleighRaleighNorth Carolina27607-
Accellacare - Winston-SalemWinston-SalemNorth Carolina27103-
NeuroScience Research CenterCantonOhio44718-
Hometown Urgent Care and Research - CincinnatiDaytonOhio45424-
Neurology Diagnostics, Inc.DaytonOhio45459-
Care Access - LimaLimaOhio45805-
North Star Medical ResearchMiddleburg HeightsOhio44130-
Care Access - YoungstownPolandOhio44514-
Central States ResearchTulsaOklahoma74136-
Optum Infusion - BendBendOregon97701-
Velocity Clinical Research, MedfordMedfordOregon97504-
Center for Cognitive HealthPortlandOregon97225-
The Clinical Trial Center, LLCJenkintownPennsylvania19046-
Care Access - PottsvillePottsvillePennsylvania17901-
Care Access Research - WarwickWarwickRhode Island02886-
Care Access - AndersonAndersonSouth Carolina29621-
Velocity Clinical Research, AndersonAndersonSouth Carolina29621-
VitaLink Research - ColumbiaColumbiaSouth Carolina29204-
Velocity Clinical Research, GaffneyGaffneySouth Carolina29340-
VitaLink Research - GreenvilleGreenvilleSouth Carolina29615-
Care Access - MauldinMauldinSouth Carolina29662-
VitaLink Research - SpartanburgSpartanburgSouth Carolina29303-
VitaLink Research - UnionUnionSouth Carolina29379-
Health ConceptsRapid CitySouth Dakota57702-
Neurology ClinicCordovaTennessee38018-
Clinical Neuroscience Solutions, Inc. dba CNS HealthcareMemphisTennessee38119-
Senior Adults Specialty ResearchAustinTexas78757-
Texas Diabetes & Endocrinology, P.A.AustinTexas78749-
Gadolin ResearchBeaumontTexas77702-
Headlands Research - BrownsvilleBrownsvilleTexas78526-
Conroe Willis Medical ResearchConroeTexas77304-
Advanced Neuro Research Center - ANRCEl PasoTexas79912-
Care Access - GeorgetownGeorgetownTexas78633-
Next Level Urgent CareHoustonTexas77057-
Optum Infusion - HoustonHoustonTexas77054-
The University of Texas Health Science Center at HoustonHoustonTexas77054-
Family Practice CenterMcAllenTexas78501-
El Faro Health and TherapeuticsRio Grande CityTexas78582-
Benchmark Research - KnickerbockerSan AngeloTexas76904-
Diagnostics Research GroupSan AntonioTexas78229-
Consano Clinical Research, LLCShavano ParkTexas78231-
Texas Valley Clinical ResearchWeslacoTexas78596-
The Memory ClinicBenningtonVermont05201-9810-
Care Access - ArlingtonArlingtonVirginia22206-
Option Care - ChantillyChantillyVirginia20151-
Dominion Medical Associates, Inc.RichmondVirginia23219-
Northwest Clinical Research CenterBellevueWashington98007-
Universal Research GroupTacomaWashington98405-
Optum Infusion - WoodinvilleWoodinvilleWashington98072-
Exemplar ResearchMorgantownWest Virginia26505-

Find similar trials in Birmingham, AL

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Parkway Medical Center· Birmingham, ALAlabama Psychiatry - Birmingham - Brookwood Medical Center Drive· Homewood, ALRehabilitation & Neurological Services· Huntsville, ALCare Access - 801 South Power Road, Mesa· Mesa, AZBanner Alzheimer's Institute· Phoenix, AZBanner Alzheimer's Institute Tucson· Tucson, AZ

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