The Trailblazer study: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease
Trailblazer 5 is a Phase 3 study that seeks to assess how safe and effective donanemab is in participants with early symptomatic Alzheimer's Disease.
It is thought that Alzheimer's Disease may be caused by a build-up of amyloid proteins in the brain and that the study medication, Donanemab, may help to remove these proteins; potentially slowing the memory loss and problems with thinking associated with Alzheimer's Disease.
This study has been approved by St Vincent's Hospital Melbourne Human Research Ethics Committee 017/24/SVHM
Participation
You may be eligible to participate if you meet the following criteria:
- aged 60 to 85 years and
- have had a gradual change in memory function over 6 months
Visits will include:
- cognitive assessments
- blood tests
- ECG and MRI scans
A study partner who has at least 10 hours of contact with the participant is required to accompany the participant to visits, to provide accurate information about the participant's cognitive and functional abilities over time.
Participant duration
The study, including screening and follow-up, has a duration of up to 93 weeks and includes 34 visits.
Available to people living in
VIC
Study begins
Monday, 25 August 2025
Study ends
Tuesday, 25 December 2029
Contact
To find out more about this study, contact:
Laura Margison
Austin Health
VIC