This study is testing a potential new treatment called donanemab (also known as LY3002813) for people with early Alzheimer’s Disease.
About this study
The purpose of this study is to evaluate a potential new treatment, donanemab, in people with early Alzheimer’s disease, compared with a medication that contains no active ingredients (a placebo). The study will also assess the safety of donanemab and any side effects that may occur during its use.
Anticipated date close of enrolment: September 2026
Who can take part
Before you take part in this study, you may need to visit our clinic to commence a Screening period, during these screening visits you will have various assessments and tests so that the study doctor can find out if you are eligible to enter the study.
You may be eligible to participate if you:
- are between the ages of 60 to 85 years.
- have a gradual and progressive change in memory function for ≥6 months.
- have a reliable study partner with whom you live or have regular contact with (who communicates with you at least 10 hours each week), and who can come with you to study visits or can be called during study visits. Your study partner will also be asked questions about your memory and day-to-day activities.
You may not be eligible to participate if you:
- have any significant neurological disease affecting the central nervous system other than Alzheimer's Disease, that may affect cognition or ability to complete the study.
Other ineligibility criteria may be determined upon your screening visit.
What's involved for you
If you agree to take part in the study and the study is suitable for you, your participation will last up to 93 weeks, and you will be required to return to the study site for at least 23 study visits.
Required assessments and tests:
- blood tests
- magnetic resonance imaging (MRI) scan
- positron emission tomography (PET) scan
- patient reported outcome questionnaires
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.