Enrolling

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

I5T-MC-AACO -

The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease.

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See if You May Qualify

Answer a few questions to see if you meet key criteria for this study.

Trial Summary

Age Range
60 - 85 years
Conditions the trial is for
Alzheimer's disease
What the trial is testing?
donanemab
Could I receive a Placebo?
Yes
Enrollment Goal
1500
Trial Dates
Oct 10, 2022 - Apr 2027
How long will I be in the trial?
The study will last up to 93 weeks and include 34 visits.
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 gradual and progressive change in memory function reported by participants or informants for ≥ 6 months

  • Participants must have MMSE score of 20 to 28 (inclusive) at baseline

  • Participants must meet 18F flortaucipir PET scan (central read) criteria does not apply to participants in the safety cohort

  • Participants must have meet 18F florbetapir PET scan (central read) criteria

  • Participants must have a study partner who will provide written informed consent to participate

Participants Must Not:

  • Participants must not have contraindication to MRI or PET scans
  • Participants must not receive current treatment with immunoglobulin G (IgG) therapy

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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.