A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT04640077
Phase
PHASE2
Status
Completed

Conditions

  • Alzheimer Disease
  • Brain Diseases
  • Central Nervous System Diseases
  • Cognitive Impairment
  • Dementia

Eligibility Criteria

Sex
ALL
Age
60 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • No Intervention — OTHER
    No intervention
  • donanemab — DRUG
    Administered IV

Study Details

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing

Key Dates

Start date
Nov 23, 2020
Status verified
May 2025
Primary completion
Feb 27, 2024
Completion
Feb 27, 2024

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Part A: Validation of Remote Scale Assessments
    Participants from the originating trials did not receive any drug in Part A. Participants were randomized 1:1 into two groups to have their cognitive and functional scales assessed. Group 1: Cognitive/functional scale assessment at the study site (on-site), followed by an at-home assessment (VTC; video teleconference), or Group 2: Cognitive/functional scale assessment at home (VTC), followed by assessment on-site. Total time in Part A was up to 24 weeks.
  • Experimental: Part B: Donanemab
    Participants who had received placebo in the originating trials received 700 milligrams (mg) donanemab administered intravenously (IV) every 4 weeks (Q4W) for 3 doses, then 1400 mg donanemab administered IV Q4W for up to 48 weeks.

Primary Outcome Measure

Part A: Intraclass Correlation Between On-Site and Video Teleconference (VTC) Assessments [ Time Frame: Baseline to 4 Weeks ]

Locations (23)

FacilityCityStateZIP
Banner Alzheimer's InstitutePhoenixArizona85006
UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND)IrvineCalifornia92697
Bradenton Research Center, Inc.BradentonFlorida34205
Merritt Island Medical Research, LLCMerritt IslandFlorida32952
Synexus Clinical Research US, Inc.OrlandoFlorida32806
Advanced Research ConsultantsPalm Beach GardensFlorida33410
Progressive Medical ResearchPort OrangeFlorida32127
Intercoastal Medical Group - Hyde ParkSarasotaFlorida34239
Stedman Clinical TrialsTampaFlorida33613
Indiana UniversityIndianapolisIndiana46202
Josephson Wallack Munshower Neurology, PCIndianapolisIndiana46256
The University of Kansas - Clinical Research CenterFairwayKansas66205
Cotton O'Neil Clinical Research Center - Central OfficeTopekaKansas66606
Boston Center for MemoryNewtonMassachusetts02459
Washington UniversitySt LouisMissouri63110
Las Vegas Medical ResearchLas VegasNevada89113
Advanced Memory Research Institute of New JerseyToms RiverNew Jersey08755
Guilford Neurologic Research, PAGreensboroNorth Carolina27405
Ohio State UniversityColumbusOhio43210
Neurology Diagnostics, Inc.DaytonOhio45459
Abington Neurological Associates, Ltd.AbingtonPennsylvania19001
Rhode Island HospitalProvidenceRhode Island02903
National Clinical Research, IncRichmondVirginia23294

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Banner Alzheimer's Institute· Phoenix, AZUC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND)· Irvine, CABradenton Research Center, Inc.· Bradenton, FLMerritt Island Medical Research, LLC· Merritt Island, FLSynexus Clinical Research US, Inc.· Orlando, FLAdvanced Research Consultants· Palm Beach Gardens, FL

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