Completed Enrollment

A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

I5T-MC-AACQ -

This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer’s disease (AD) and explore participant characteristics that might predict risk of ARIA.

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
800
Trial Dates
Feb 28, 2023 - May 2025
How long will I be in the trial?
The study will last approximately 91 weeks and 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 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 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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