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NCT04640077 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Alzheimer Disease and Dementia, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
95
Enrollment target
20
Study locations

NCT04640077 is a Phase 2 study of Alzheimer Disease and Dementia that has completed, run by Eli Lilly and Company. The registered enrollment target is 95 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT04640077, a Phase 2 study of Alzheimer Disease and Dementia, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 2
Development phase
95 participants
Enrollment target
20
Study locations

Study Summary

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

Interventions

  • OTHER No Intervention
  • DRUG donanemab

Study Locations (20)

Florida

  • Bradenton Research Center, Inc. - Bradenton
  • Merritt Island Medical Research, LLC - Merritt Island
  • Synexus Clinical Research US, Inc. - Orlando
  • Advanced Research Consultants - Palm Beach Gardens
  • Progressive Medical Research - Port Orange
  • Intercoastal Medical Group - Hyde Park - Sarasota
  • Stedman Clinical Trials - Tampa

Indiana

  • Indiana University - Indianapolis
  • Josephson Wallack Munshower Neurology, PC - Indianapolis

Kansas

  • The University of Kansas - Clinical Research Center - Fairway
  • Cotton O'Neil Clinical Research Center - Central Office - Topeka

Ohio

  • Ohio State University - Columbus
  • Neurology Diagnostics, Inc. - Dayton

Arizona

  • Banner Alzheimer's Institute - Phoenix

California

  • UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND) - Irvine

Massachusetts

  • Boston Center for Memory - Newton

Missouri

  • Washington University - St Louis

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2020-11-23
Est. Completion 2024-02-27
Phase Phase 2

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT04640077

The ClinicalTrials.gov registry entry for NCT04640077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (97% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which No Intervention is the first listed.

NCT04640077 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Indiana, Kansas.

Frequently Asked Questions

What is clinical trial NCT04640077 about?

NCT04640077 is a clinical study titled "A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)". 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

What is the current status of trial NCT04640077?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2020-11-23. Estimated completion is 2024-02-27.

What conditions does trial NCT04640077 study?

This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Cognitive Impairment, Central Nervous System Diseases, Brain Diseases.

What interventions are being tested in trial NCT04640077?

The interventions under investigation include: No Intervention (OTHER), donanemab (DRUG).

Who is sponsoring clinical trial NCT04640077?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04640077 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.