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Early Alzheimer's Disease study

Official Study Name:

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

  • Organizer:

Mechanism of Action

  • 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.

  • The study will last approximately 91 weeks and include up to 26 visits.

  • Trial Dates: Feb 27, 2023 - May 2025


Inclusion & Exclusion criteria

  • Participants must not have contraindication to MRI or PET scans

  • Participants must not receive current treatment with immunoglobulin G (IgG) therapy


Participation requirements

  • 60 - 85 years

  • 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


Type of study

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  • Phase III

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