A Follow-On Study of Donanemab (LY3002813) With Video Assessments in Participants With Alzheimer's Disease (TRAILBLAZER-EXT)

Completed · Phase 2

Conditions studied: Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Cognitive Impairment

In brief

The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer's disease and to validate neuropsychological assessments administered over videoconferencing

Key facts

Study ID

NCT04640077

Run by

Eli Lilly and Company

People needed

95

Starts

2020-11-23

Expected to finish

2024-02-27

Last updated by the study team

2025-06-13

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the TRAILBLAZER-ALZ study.
• Have a study partner
• Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A

You may not qualify if…

• Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study.
• Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study.
• Poor venous access
• Contraindication to PET or MRI imaging

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• UC Irvine-Institute for Memory Impairments and Neurological Disorders (UCI MIND) — Irvine, California, United States
• Bradenton Research Center, Inc. — Bradenton, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• Synexus Clinical Research US, Inc. — Orlando, Florida, United States
• Advanced Research Consultants — Palm Beach Gardens, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Intercoastal Medical Group - Hyde Park — Sarasota, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States
• The University of Kansas - Clinical Research Center — Fairway, Kansas, United States
• Cotton O'Neil Clinical Research Center - Central Office — Topeka, Kansas, United States
• Boston Center for Memory — Newton, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Advanced Memory Research Institute of New Jersey — Toms River, New Jersey, United States
• Guilford Neurologic Research, PA — Greensboro, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Neurology Diagnostics, Inc. — Dayton, Ohio, United States
• Abington Neurological Associates, Ltd. — Abington, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• National Clinical Research, Inc — Richmond, Virginia, United States
• Bruyère Research Institute — Ottawa, Ontario, Canada
• Toronto Memory Program — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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