I5T-MC-AACR (TRAILBLAZER-REAL OUS)
Research type
Research Study
Full title
A Phase 3b, Pragmatic, Single-arm Study of Interventional, Open-label Use of Donanemab with Usual Care and an External Control of Usual Care Alone Comparing Dependency and Other Health Outcomes in Participants with Early Symptomatic Alzheimer’s Disease (AD).
IRAS ID
1010325
Contact name
Andrew Pain
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
This Study is a phase 3 open-label study being carried out to find out more about the study drug, called donanemab, when taken in combination with the usual care in patients with early symptomatic Alzheimer’s Disease (AD). Donanemab is a monoclonal antibody. This means that it is an antibody that is active against a single specific target structure. Antibodies are usually produced naturally by the body’s immune system to protect it from sources of infection or agents that may be harmful to the body. Artificial antibodies, such as donanemab, can be manufactured and used in medications that can help prevent or slow the progression of the disease. The study aims find out more about whether receiving donanemab, in combination with the usual treatments for AD, helps people with AD to lessen their dependence on others in comparison to receiving the usual treatments alone. The study will look at the ability of the participants to maintain their independence for a longer period of time, the impact on their quality of life, along with the impact on their caregivers. The study will also look at how safe the donanemab is.
This study is nested within the independently conducted IONA Longitudinal Cohort Study (LCS). This AACR study focuses only on the administration of the study drug and associated safety endpoint measurements. All other endpoint data is collected in the IONA LCS. Participants must remain in IONA LCS and have consented to be contacted about other research studies to be part of this AACR study.
The study will enrol approximately 918 participants. Participants enrolled in the IONA study will be randomly invited to take part in the AACR study and be treated with donanemab. Donanemab-treated participants within AACR will have a treatment duration up to approximately 72 weeks. Donanemab will be administered at a schedule of 700 mg intravenously (IV) every 4 weeks for first 3 doses and then 1400 mg IV every 4 weeks.
The study is Sponsored by Eli Lilly.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
24/SC/0284
Date of REC Opinion
8 Nov 2024
REC opinion
Further Information Unfavourable Opinion