A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Part of paid clinical trials in Fullerton, California.

Sponsor
Eli Lilly and Company
Study ID
NCT05108922
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Donanemab — DRUG
    Participants received 700 milligram (mg) donanemab administered by intravenous (IV) infusion every 4 weeks (Q4W) for first three doses and then 1400 mg IV Q4W.
  • Aducanumab — DRUG
    Participants received aducanumab administered by IV infusion per US label (prescribing information/routine clinical practice).

Study Details

The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).

Key Dates

Start date
Nov 16, 2021
Status verified
Nov 2024
Primary completion
Sep 9, 2022
Completion
Sep 19, 2023

Study Design

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

Arms

  • Experimental: Donanemab
    Donanemab is administered intravenously (IV) every 4 weeks (Q4W).
  • Active Comparator: Aducanumab
    Aducanumab administered IV per US label.

Primary Outcome Measure

Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on Donanemab Versus Aducanumab [ Time Frame: 6 Months ]

Locations (31)

FacilityCityStateZIPSite coordinators
Neurology Center of North Orange CountyFullertonCalifornia92835-
Irvine Clinical ResearchIrvineCalifornia92614-
California Neuroscience Research Medical Group, Inc.Sherman OaksCalifornia91403-
Institute for Neurodegenerative DisordersNew HavenConnecticut06510-
JEM Research InstituteAtlantisFlorida33462-
Brain Matters ResearchDelray BeachFlorida33445-
Neuropsychiatric Research Center of Southwest FloridaFort MyersFlorida33912-
Infinity Clinical Research, LLCHollywoodFlorida33024-
Jacksonville Center for Clinical ResearchJacksonvilleFlorida32216-
Charter Research - Lady LakeLady LakeFlorida32159-
ClinCloud - MaitlandMaitlandFlorida32751-
ClinCloud - VieraMelbourneFlorida32940-
Merritt Island Medical Research, LLCMerritt IslandFlorida32952-
Brainstorm ResearchMiamiFlorida33176-
Optimus U CorporationMiamiFlorida33125-
Brain Matters ResearchStuartFlorida34997-
Axiom Clinical Research of FloridaTampaFlorida33609-
Conquest ResearchWinter ParkFlorida32789-
Columbus Memory Center, PCColumbusGeorgia31909-
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256-
Donald S. Marks M.D., P.C.PlymouthMassachusetts02360-
Adams ClinicalWatertownMassachusetts02472-
Clinical Research ProfessionalsChesterfieldMissouri63005-
Las Vegas Medical ResearchLas VegasNevada89113-
The Cognitive and Research Center of New JerseySpringfieldNew Jersey07081-
Advanced Memory Research Institute of New JerseyToms RiverNew Jersey08755-
Neurology Diagnostics, Inc.DaytonOhio45459-
Abington Neurological Associates, Ltd.AbingtonPennsylvania19001-
The Clinical Trial Center, LLCJenkintownPennsylvania19046-
Kerwin Medical CenterDallasTexas75231-
National Clinical Research, IncRichmondVirginia23294-

Find similar trials in Fullerton, CA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Neurology Center of North Orange County· Fullerton, CAIrvine Clinical Research· Irvine, CACalifornia Neuroscience Research Medical Group, Inc.· Sherman Oaks, CAInstitute for Neurodegenerative Disorders· New Haven, CTJEM Research Institute· Atlantis, FLBrain Matters Research· Delray Beach, FL

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