A study to determine the safety and efficacy of a drug called donanemab in treating or delaying the progression of Alzheimer’s dementia.
About this study
This is a phase III, anti-amyloid study for mild cognitive impairment and early Alzheimer’s dementia.
Participants will first attend a screen visit at the Royal Melbourne Hospital to ensure that they meet the criteria for the study. Once enrolled, they will be randomised in a 1:1 ratio to receive either donanemab or placebo.
The study will involve attending approximately 20 study visits at the Royal Melbourne Hospital over 76 weeks. There will also be a 48 week follow-up period. Participants will receive the drug by intravenous infusion during these visits.
Anticipated enrolment close date: 30 September 2021
Who can take part
Participants must meet the following criteria:
- 60 to 85 years of age inclusive
- Gradual and progressive change in memory function for 6 months or longer
- Have received a diagnosis of mild cognitive impairment or mild or early stage Alzheimer’s dementia
- They must have a carer/study partner to attend study visits with them
The study involves the following assessments:
- MRI brain scan (5 scans throughout the duration of study)
- PET brain scan (approximately 4 scans throughout the duration of study)
- Medical examination by a neurologist
- Blood tests
- Cognitive tests and questionnaires
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.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.