A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

Completed · Phase 3

Conditions studied: Mild Cognitive Impairment (MCI), Alzheimer Disease

In brief

The main purpose of this study is to compare donanemab to aducanumab on brain amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).

Key facts

Study ID

NCT05108922

Run by

Eli Lilly and Company

People needed

148

Starts

2021-11-16

Expected to finish

2023-09-19

Last updated by the study team

2024-11-29

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
• Meet florbetapir F18 PET scan criteria.
• A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
• Must consent to apolipoprotein E (ApoE) genotyping
• Must have a mini mental state examination (MMSE) score between 20 and 30
• Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
• Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
• Women not of childbearing potential may participate

You may not qualify if…

• Significant neurological disease affecting the central nervous system (other than AD), that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures).
• Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately
• ≤24 months.
• History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
• History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
• Have had prior or current treatment with donanemab or aducanumab
• Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
• Prior or current participation in any immunotherapy study targeting Amyloid beta

Where it is running

• Neurology Center of North Orange County — Fullerton, California, United States
• Irvine Clinical Research — Irvine, California, United States
• California Neuroscience Research Medical Group, Inc. — Sherman Oaks, California, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
• Infinity Clinical Research, LLC — Hollywood, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Charter Research - Lady Lake — Lady Lake, Florida, United States
• ClinCloud - Maitland — Maitland, Florida, United States
• ClinCloud - Viera — Melbourne, Florida, United States
• Merritt Island Medical Research, LLC — Merritt Island, Florida, United States
• Optimus U Corporation — Miami, Florida, United States
• Brainstorm Research — Miami, Florida, United States
• Brain Matters Research — Stuart, Florida, United States
• Axiom Clinical Research of Florida — Tampa, Florida, United States
• Conquest Research — Winter Park, Florida, United States
• Columbus Memory Center, PC — Columbus, Georgia, United States
• Josephson Wallack Munshower Neurology, PC — Indianapolis, Indiana, United States
• Donald S. Marks M.D., P.C. — Plymouth, Massachusetts, United States
• Adams Clinical — Watertown, Massachusetts, United States
• Clinical Research Professionals — Chesterfield, Missouri, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• The Cognitive and Research Center of New Jersey — Springfield, New Jersey, United States

Full record on ClinicalTrials.gov

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