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

Trial ID or NCT#

NCT04437511

Status

not recruiting iconNOT RECRUITING

Purpose

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

Official Title

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Eligibility Criteria

Ages Eligible for Study: 60 to 85
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months* MMSE score of 20 to 28 (inclusive) at baseline* Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort* Meet 18F florbetapir PET scan (central read) criteria* Have a study partner who will provide written informed consent to participate
    1. Exclusion Criteria:
  2. * Contraindication to MRI or PET scans* Current treatment with immunoglobulin G (IgG) therapy
Exclusion Criteria:
  1. * Contraindication to MRI or PET scans* Current treatment with immunoglobulin G (IgG) therapy
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Investigator(s)

Sharon Sha, MD, MS
Sharon Sha, MD, MS
Memory disorders specialist, Movement disorders specialist
Clinical Professor, Adult Neurology

View on ClinicalTrials.gov