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

I5T-MC-AACN -

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

Trial Summary

Age Range
50 - 85 years
Conditions the trial is for
Alzheimer's Disease
What the trial is testing?
Donanemab, Aducanumab
Could I receive a Placebo?
No
Enrollment Goal
148
Trial Dates
Nov 16, 2021 - Sep 19, 2023
How long will I be in the trial?
Your participation could last up to 127 weeks and include up to 25 visits to the study center.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participants must have had slow or rapid change in memory for the last 6 months

  • Participant must have a reliable study partner with whom they have regular contact and who can provide written informed consent to participate and attend study appointments

Participants Must Not:

  • Participants must not have a significant disease of the brain such as Parkinson's disease, multiple concussions, that affects completion of the study

  • Participants must not have history of heart attack or stroke, epilepsy or seizures

  • Participants must not have serious or unstable illness that could interfere with the analysis of the study or have a life expectancy <24 months

  • Participants must not have serious risk for suicide

  • Participants must not have a history of severe drug allergies

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Clinical Trial Resources

Alzheimer's Research

To learn more about Alzheimer’s, memory loss and ongoing clinical trials in this area, visit our Alzheimer’s Disease Research page.

Learn More

Neurodegenerative Disease Research

To learn more about neurological disorders and ongoing clinical trials in the area, visit our Neurological Disorders Research page.

Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.