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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT03367403
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Donanemab — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV
  • LY3202626 — DRUG
    Administered orally

Study Details

The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Key Dates

Start date
Dec 18, 2017
Status verified
Sep 2022
Primary completion
Dec 4, 2020
Completion
Sep 21, 2021

Study Design

Enrollment
272 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab Monotherapy (Donanemab-M)
    Participants received 700 milligram (mg) donanemab intravenously (IV) every 4 weeks (Q4W) x 3 doses, then 1400 mg donanemab IV Q4W for up to 72 weeks.
  • Placebo Comparator: Placebo
    Participants received placebo IV Q4W for up to 72 weeks.
  • Experimental: Donanemab in Combination With LY3202626 (Donanemab-C)
    Participants received 700 mg donanemab IV Q4W x 3 doses, then 1400 mg donanemab IV Q4W in combination with 12 mg of LY3202626 orally for up to 72 weeks. As per protocol amendment (d) approved on Oct 9, 2018, donanemab in combination with LY3202626 (donanemab-C) arm discontinued as there was a low probability of identifying a statistically significant effect of 12mg of LY3202626 slowing cognitive decline.

Primary Outcome Measure

Change From Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, 76 Weeks ]

Locations (56)

FacilityCityStateZIPSite coordinators
Banner Alzheimer's InstitutePhoenixArizona85006-
Banner Sun Health Research InstituteSun CityArizona85351-
Neurology Center of North Orange CountyFullertonCalifornia92835-
Institute for Memory Impairment & Neurological DisordersIrvineCalifornia92697-
Irvine Clinical Research CenterIrvineCalifornia92614-
Pharmacology Research InstituteNewport BeachCalifornia92660-
Pacific Research Network IncSan DiegoCalifornia92103-
Sharp Mesa Vista HospitalSan DiegoCalifornia92123-
Syrentis Clinical ResearchSanta AnaCalifornia92705-
Associated Neurologists, PC - DanburyDanburyConnecticut06810-
KI Health Partners, LLC d/b/a NE Inst. for Clin. Res.StamfordConnecticut06905-
JEM Research InstituteAtlantisFlorida33462-
Bradenton Research CenterBradentonFlorida34205-
Brain Matters ResearchDelray BeachFlorida33445-
Infinity Clinical Research, LLCHollywoodFlorida33021-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Merritt Island Medical Research LLCMerritt IslandFlorida32592-
Miami Jewish Health SystemsMiamiFlorida33137-
Pharmax Research ClinicMiamiFlorida33126-
Suncoast Clinical ResearchNew Port RicheyFlorida34652-
Compass ResearchOrlandoFlorida32806-
Palm Beach Neurological GroupPalm Beach GardensFlorida33410-
Quantum LaboratoriesPompano BeachFlorida33064-
Progressive Medical ResearchPort OrangeFlorida32127-
Intercoastal Medical GroupSarasotaFlorida34239-
Axiom ResearchTampaFlorida33609-
Stedman Clinical TrialsTampaFlorida33613-
Compass ResearchThe VillagesFlorida32162-
Great Lakes Clinical TrialsChicagoIllinois60640-
Alexian Brothers Medical CenterElk Grove VillageIllinois60007-
Indiana University School of MedicineIndianapolisIndiana46202-
Josephson Wallack Munshower NeurologyIndianapolisIndiana46256-
University of Kansas HospitalFairwayKansas66160-
Cotton O'Neil ClinicTopekaKansas66606-
McLean HospitalBelmontMassachusetts02478-
ActivMed Practices & Research, IncMethuenMassachusetts01844-
Boston Center for MemoryNewtonMassachusetts02459-
Donald S MarksPlymouthMassachusetts02360-4843-
Washington UniversitySt LouisMissouri63108-
Las Vegas Medical ResearchLas VegasNevada89113-
Advanced Memory Research Institute of New JerseyToms RiverNew Jersey08755-
Behavioral Health Center ResearchCharlotteNorth Carolina28211-
Guilford Neurologic AssociatesGreensboroNorth Carolina27405-
Raleigh Neurology AssociatesRaleighNorth Carolina27607-
Piedmont Medical ResearchWinston-SalemNorth Carolina27103-
Insight Clinical TrialsBeachwoodOhio44122-
Ohio State University Medical CenterColumbusOhio43210-
Neurology Diagnostics, Inc.DaytonOhio45459-
Abington Neurological AssociatesWillow GrovePennsylvania19090-
Butler HospitalProvidenceRhode Island02906-
Rhode Island HospitalProvidenceRhode Island02903-
Texas Neurology, PADallasTexas75214-
Houston MethodistHoustonTexas77030-
The Memory ClinicBenningtonVermont05201-
Cognition HealthFairfaxVirginia22031-
National Clinical Research - RichmondRichmondVirginia23294-

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Alzheimer's Institute· Phoenix, AZBanner Sun Health Research Institute· Sun City, AZNeurology Center of North Orange County· Fullerton, CAInstitute for Memory Impairment & Neurological Disorders· Irvine, CAIrvine Clinical Research Center· Irvine, CAPharmacology Research Institute· Newport Beach, CA

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