Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease
Sponsor:
Eli Lilly and Company
Brief 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.
participants with early Alzheimer’s disease.
Criteria
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
– 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
Locations
- North County Neurology Associates, Carlsbad, California, United States, 92011
- Irvine Clinical Research Center, Irvine, California, United States, 92614
- Pacific Research Network, San Diego, California, United States, 92103
- Sharp Mesa Vista Hospital, San Diego, California, United States, 92123
- Univ of California San Francisco, San Francisco, California, United States, 94158