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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Key facts

Study ID

NCT04437511

Run by

Eli Lilly and Company

People needed

1736

Starts

2020-06-19

Expected to finish

2028-11-01

Last updated by the study team

2025-08-29

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

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

Where it is running

• Xenoscience — Phoenix, Arizona, United States
• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Perseverance Research Center — Scottsdale, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• Banner Alzheimer's Institute Tucson — Tucson, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• Health Initiatives Research — Fayetteville, Arkansas, United States
• North County Neurology Associates — Carlsbad, California, United States
• Wr- Pri, Llc — Encino, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Clinical Research — Irvine, California, United States
• Kaizen Brain Center — La Jolla, California, United States
• Senior Clinical Trials, Inc. — Laguna Hills, California, United States
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• Clinical Research Institute — Los Angeles, California, United States
• Neurovations — Napa, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Stanford Neuroscience Health Center — Palo Alto, California, United States
• SC3 Research - Pasadena — Pasadena, California, United States
• PCND Neurology — Poway, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Gilbert Neurology — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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