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Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease

Royal Melbourne Hospital

Trailblazer 5 is a Phase 3 study that seeks to assess how safe and effective the medication, 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 the St Vincent Hospital (Melbourne) Human Research Ethics Committee

Participation

The study is open to people

  • aged 60 to 85 years 
  • experiencing gradual and progressive change in memory function for approximately six months. 

It is essential that participants have a study partner that has at least 10 hours of contact with the participant per week, and can accompany the participant to visits.

Visits may include cognitive testing, blood tests, an ECG, MRI and PET scans. Rural participants are also welcome.


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, 1 January 2024


Study ends

Monday, 31 December 2029

Contact

To find out more about this study, contact:

Sophia Robinson and Cassandra Yankoff

Royal Melbourne Hospital

DementiaTrials@mh.org.au

(03) 9342 4799

Royal Melbourne Hospital 300 Grattan St Parkville VIC 3050 , VIC

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Last updated
16 May 2025