Completed Enrollment

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

I5T-MC-AACI -

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

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
1736
Trial Dates
Jun 19, 2020 - Aug 2025
How long will I be in the trial?
The study will last about 127 weeks and may include up to 26 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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