A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04437511
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Donanemab — DRUG
    Given IV
  • Placebo — DRUG
    Given IV

Study Details

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Key Dates

Start date
Jun 19, 2020
Status verified
Aug 2025
Primary completion
Apr 14, 2023
Completion
Nov 30, 2028

Study Design

Enrollment
1,736 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab
    Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
  • Placebo Comparator: Placebo
    Participants received placebo given IV.

Primary Outcome Measure

Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) (Overall Population) [ Time Frame: Baseline, Week 76 ]

Locations (185)

FacilityCityStateZIPSite coordinators
Gilbert NeurologyGilbertArizona85297-
Banner Alzheimer's InstitutePhoenixArizona85006-
XenosciencePhoenixArizona85004-
Perseverance Research CenterScottsdaleArizona85254-
Banner Sun Health Research InstituteSun CityArizona85351-
Banner Alzheimer's Institute TucsonTucsonArizona85718-
Center for NeurosciencesTucsonArizona85718-
Health Initiatives ResearchFayettevilleArkansas72703-
North County Neurology AssociatesCarlsbadCalifornia92011-
Wr- Pri, LlcEncinoCalifornia91316-
Neuro-Pain Medical CenterFresnoCalifornia93710-
Neurology Center of North Orange CountyFullertonCalifornia92835-
Irvine Clinical ResearchIrvineCalifornia92614-
Kaizen Brain CenterLa JollaCalifornia92037-
Senior Clinical Trials, Inc.Laguna HillsCalifornia92653-
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-
Clinical Research InstituteLos AngelesCalifornia90048-
USC Keck School of MedicineLos AngelesCalifornia90033-
NeurovationsNapaCalifornia94558-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Stanford Neuroscience Health CenterPalo AltoCalifornia94304-
SC3 Research - PasadenaPasadenaCalifornia91105-
PCND NeurologyPowayCalifornia92064-
Anderson Clinical ResearchRedlandsCalifornia92374-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
Pacific Research NetworkSan DiegoCalifornia92103-
Sharp Neurocognitive Research CenterSan DiegoCalifornia92123-
UCSF Memory and Aging CenterSan FranciscoCalifornia94158-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
California Neuroscience Research Medical Group, Inc.Sherman OaksCalifornia91403-
Tilda ResearchTustinCalifornia92780-
Mountain Neurological Research CenterBasaltColorado81621-
Alpine Clinical Research CenterBoulderColorado80301-
Colorado Springs Neurological AssociatesColorado SpringsColorado80907-
Colorado Neurological Research Center, PCDenverColorado80210-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
Yale University, Alzheimer's Disease Research UnitNew HavenConnecticut06510-
Research Center for Clinical StudiesNorwalkConnecticut06851-
Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamfordConnecticut06905-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
JEM Research InstituteAtlantisFlorida33462-
VIN-Julie SchwartzbardAventuraFlorida33180-
Neurology Offices of South FloridaBoca RatonFlorida33428-
SFM Clinical ResearchBoca RatonFlorida33487-
Brain Matters ResearchDelray BeachFlorida33445-
Cohen Medical AssociatesDelray BeachFlorida33446-
Integrity Clinical ResearchDoralFlorida33166-
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912-
Finlay Medical ResearchGreenacres CityFlorida33467-
MD ClinicalHallandaleFlorida33009-
AGA Clinical TrialsHialeahFlorida33012-
Indago Research & Health Center, IncHialeahFlorida33012-
Infinity Clinical Research, LLCHollywoodFlorida33024-
Encore Research Group- Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Accel Research Sites - Lakeland Clinical Research UnitLakelandFlorida33803-
ClinCloud - MaitlandMaitlandFlorida32751-
Merritt Island Medical Research, LLCMerritt IslandFlorida32952-
Allied Biomedical Research InstituteMiamiFlorida33155-
Ezy Medical ResearchMiamiFlorida33175-
Finlay Medical ResearchMiamiFlorida33126-
Florida International Research CenterMiamiFlorida33173-
Future Care SolutionMiamiFlorida33142-
Homestead Associates in ResearchMiamiFlorida33032-
Miami Dade Medical Research Institute, LLCMiamiFlorida33176-
Miami Jewish healthMiamiFlorida33137-
New Horizon Research CenterMiamiFlorida33165-
Optimus U CorporationMiamiFlorida33135-
The Neurology Research GroupMiamiFlorida33176-
VIN-Victor FaradjiMiamiFlorida33176-
Mount Sinai Cancer CenterMiami BeachFlorida33140-
Goji Group - Research Trials GroupMiami LakesFlorida33016-
Collier Neurologic SpecialistsNaplesFlorida34105-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Renstar Medical ResearchOcalaFlorida34470-
Sensible Healthcare, LLCOcoeeFlorida34761-
Medical Research Group of Central FloridaOrange CityFlorida32763-
Headlands Research OrlandoOrlandoFlorida32819-
Synexus Clinical Research US, Inc.OrlandoFlorida32806-
IMIC, Inc.Palmetto BayFlorida33157-
Emerald Coast Neurology - Airport BoulevardPensacolaFlorida32504-
Quantum Laboratories Clinical ResearchPompano BeachFlorida33064-
Progressive Medical ResearchPort OrangeFlorida32127-
Intercoastal Medical GroupSarasotaFlorida34239-
Roskamp Institute Clinical Trials DivisionSarasotaFlorida34243-
Suncoast Neuroscience Associates, Inc.St. PetersburgFlorida33713-
Alzheimer's Research and Treatment CenterStuartFlorida34997-
Brain Matters ResearchStuartFlorida34997-
Tallahassee Neurological ClinicTallahasseeFlorida32308-
Axiom Clinical Research of FloridaTampaFlorida33609-
Stedman Clinical TrialsTampaFlorida33613-
USF Health Byrd Alzheimer's InstituteTampaFlorida33613-
Charter Research - Lady LakeThe VillagesFlorida32162-
Synexus Clinical Research US, Inc.The VillagesFlorida32162-
Alzheimer's Research and Treatment CenterWellingtonFlorida33414-
Palm Beach NeurologyWest Palm BeachFlorida33407-
Charter Research - Winter ParkWinter ParkFlorida32803-
Conquest ResearchWinter ParkFlorida32789-
Gwinnett Research InstituteBufordGeorgia30519-
Columbus Memory Center, LLCColumbusGeorgia31909-
NeuroStudiesDecaturGeorgia30030-
Center for Advanced Research & EducationGainesvilleGeorgia30501-
Northwest Clinical TrialsBoiseIdaho83704-
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640-
AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchElk Grove VillageIllinois60007-
Advocate Medical GroupPark RidgeIllinois60068-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Indiana UniversityIndianapolisIndiana46202-
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256-
McFarland Clinic, PCAmesIowa50010-
Covenant Medical CenterWaterlooIowa50702-
The University of Kansas - Clinical Research CenterFairwayKansas66205-
College Park Family Care Center/Multi Specialty Clinical ResOverland ParkKansas66212-
Cotton O'Neil Clinical Research Center - Central OfficeTopekaKansas66606-
Ascension Via Christi ResearchWichitaKansas67214-
Maine Medical Center-Maine Medical Partners NeurologyScarboroughMaine04074-
Boston Clinical TrialsBostonMassachusetts02131-
Brigham and Women's HospitalBostonMassachusetts02115-
NECCR PrimaCare ResearchFall RiverMassachusetts02721-
BTC NetworkNew BedfordMassachusetts02740-
Boston Center for MemoryNewtonMassachusetts02459-
Donald S. Marks M.D., P.C.PlymouthMassachusetts02360-
Alzheimers Disease CenterQuincyMassachusetts02169-
MedVadis Research CorporationWalthamMassachusetts02451-
Adams ClinicalWatertownMassachusetts02472-
QUEST Research InstituteFarmington HillsMichigan48334-
Precise Research CentersFlowoodMississippi39232-
Citizens Memorial Hospital DistrictBolivarMissouri65613-
Clinical Research ProfessionalsChesterfieldMissouri63005-
North Kansas City HospitalNorth Kansas CityMissouri64116-
Sharlin Health and NeurologyOzarkMissouri65721-
Arch Clinical TrialsSt LouisMissouri63141-
Las Vegas Medical ResearchLas VegasNevada89128-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
Advanced Memory Research Institute of New JerseyToms RiverNew Jersey08755-
Bio Behavioral HealthToms RiverNew Jersey08755-
Albany Medical CollegeAlbanyNew York12208-
Neurological Associates AlbanyAlbanyNew York12208-
Dent Neurologic InstituteAmherstNew York14226-
University at Buffalo - UBMD NeurologyBuffaloNew York14203-
Clarity Clinical ResearchEast SyracuseNew York13057-
NYU Langone HealthNew YorkNew York10016-
University of Rochester Medical CenterRochesterNew York14642-
Richmond Behavioral AssociatesStaten IslandNew York10312-
SUNY Upstate Medical UniversitySyracuseNew York13210-
CHS-Behavioral Health ResearchCharlotteNorth Carolina28211-
Guilford Neurologic Associates, IncGreensboroNorth Carolina27405-
AMC ResearchMatthewsNorth Carolina28105-
Carteret Medical GroupMorehead CityNorth Carolina28557-
Accellacare - Winston-SalemWinston-SalemNorth Carolina27103-
NeuroScience Research CenterCantonOhio44718-
Valley Medical ResearchCentervilleOhio45459-
Rapid Medical ResearchClevelandOhio44122-
Ohio State UniversityColumbusOhio43210-
Neurology Diagnostics, Inc.DaytonOhio45459-
University of Cincinnati Physicians Company, LLCDaytonOhio45417-
IPS Research CompanyOklahoma CityOklahoma73106-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Central States ResearchTulsaOklahoma74136-
Center for Cognitive HealthPortlandOregon97225-
Summit HeadlandsPortlandOregon97210-
Abington Neurological Associates, Ltd.AbingtonPennsylvania19001-
Penn Medicine: University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Keystone Clinical StudiesPlymouth MeetingPennsylvania19462-
Rhode Island Mood & Memory Research InstituteEast ProvidenceRhode Island02914-
Prism Health Richland Department of Neurology ResearchColumbiaSouth Carolina29203-
Neurology Clinic, P.C.CordovaTennessee38018-
Clinical Neuroscience Solutions, Inc. dba CNS HealthcareMemphisTennessee38119-
Senior Adults Specialty ResearchAustinTexas78757-
Gadolin ResearchBeaumontTexas77702-
Kerwin Medical CenterDallasTexas75231-
Neurology Consultants of Dallas, PADallasTexas75243-
InSite Clinical ResearchDeSotoTexas75115-
Houston Methodist HospitalHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
Central Texas Neurology ConsultantsRound RockTexas78681-
Glenn Biggs Institute for Alzheimers & Neurodegenerative DiseasesSan AntonioTexas78229-3900-
The Memory ClinicBenningtonVermont05201-9810-
Integrated Neurology Services - Falls ChurchArlingtonVirginia22207-
Sentara Norfolk General HospitalNorfolkVirginia23510-
National Clinical Research, IncRichmondVirginia23294-
Northwest Clinical Research CenterBellevueWashington98007-
EvergreenHealth Medical CenterKirklandWashington98034-
University of Washington - Harborview Medical CenterSeattleWashington98104-
Kingfisher CooperativeSpokaneWashington99201-
Universal Research GroupTacomaWashington98405-

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