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

I5T-MC-AACH -

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 video scale assessments.

Trial Summary

Age Range
60 - 90 years
Conditions the trial is for
Alzheimer's Disease
What the trial is testing?
Donanemab
Could I receive a Placebo?
No
Enrollment Goal
94
Trial Dates
Nov 23, 2020 - Feb 27, 2024
How long will I be in the trial?
The study will last about 124 weeks and may include up to 20 visits.
Trial Phase
II

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

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

  • Participants must have met 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 immunoglobin 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.