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COMPLETED Phase 2

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

NCT04640077 · View on ClinicalTrials.gov ↗

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

704 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04640077

The ClinicalTrials.gov registry entry for NCT04640077 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04640077 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Indiana, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04640077?

The interventions under investigation include: No Intervention (OTHER), donanemab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04640077?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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