Summary

Eligibility
for people ages 60-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Julio Rojas-Martinez
Photo of Julio Rojas-Martinez
Julio Rojas-Martinez

Description

Summary

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

Keywords

Alzheimer Disease Alzheimer's Dementia Cognitive Impairment Amyloid Plaque Donanemab

Eligibility

You can join if…

Open to people ages 60-85

  • 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

You CAN'T join if...

  • Contraindication to MRI or PET scans
  • Current treatment with immunoglobulin G (IgG) therapy

Locations

  • Univ of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • Neuro-Pain Medical Center accepting new patients
    Fresno California 93710 United States

Lead Scientist at UCSF

  • Julio Rojas-Martinez
    Assistant Professor, Neurology. Authored (or co-authored) 39 research publications. Research interests: Clinical trials · plasma biomarkers · non-pharmacological management.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Donanemab (LY3002813) in Participants with Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
ID
NCT04437511
Phase
Phase 3
Study Type
Interventional
Last Updated