This study is investigating the effectiveness of medication JNJ-63733657 in delaying the progression of Alzheimer’s dementia by reducing the propagation of tau proteins.
About this study
Participants attend an initial visit at the RMH to ensure that they meet the criteria for the study. Once enrolled in the study, participants are randomised in a 2:1 ratio to receive the medication or placebo.
Study duration is 4.5 years. It involves 36 to 38 visits to the RMH for intravenous infusion every 4 weeks.
Anticipated enrolment close date is December 2023
Who can take part
Participants must meet the following criteria:
- 55 to 80 years of age inclusive
- Gradual and progressive change in memory function for 6 months or longer
- Received a diagnosis of mild or early stage Alzheimer’s dementia
- Must have a carer or study partner to attend study visits
What's involved
In addition to medication administration, the study involves the following assessments:
- MRI brain scan (approximately 10 throughout the duration of study)
- PET brain scan (approximately 5 throughout the duration of study)
- Medical examination by neurologist
- Blood draw
- Cognitive tests and 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.
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.