Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation
Status:
NOT_YET_RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome.
The main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain.
Participants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study.
Participants will:
* Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks
* Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging \[MRI\] and positron emission tomography \[PET\] ), blood draws and memory tests.
* Have a study partner who who can provide information about the participant and can join participant for some of the study visits.
Phase:
PHASE4
Details
Lead Sponsor:
Michael Rafii, MD, PhD
Collaborators:
Alzheimer's Clinical Trials Consortium Alzheimer's Therapeutic Research Institute Eli Lilly and Company National Institute on Aging (NIA)