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A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Not Recruiting
Trial ID: NCT04437511
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
Stanford Investigator(s)
Sharon Sha, MD, MS
Clinical Professor, Neurology & Neurological Sciences
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* Contraindication to MRI or PET scans
* Current treatment with immunoglobulin G (IgG) therapy
Intervention(s):
drug: Donanemab
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305