A clinical trial to assess the efficacy of Simufilam in mild to moderate Alzheimer’s dementia
About this study
This study is aimed at investigating the efficacy of Simufilam in slowing Alzheimer’s disease progression. We aim to do this by reducing toxic signalling of amyloid and restoring the altered Filamin A (FLNA) protein in Alzheimer’s disease. People interested in participating in this study will need to attend a screen visit at the Royal Melbourne Hospital (onsite) to assess eligibility for enrolment. After which, they will be randomised in a 1:1 ratio to receive the drug or placebo (in the form of tablets).
The duration of this study is one year (or 52 weeks) and will involve seven visits to the Royal Melbourne Hospital.
Anticipated enrolment close date: December 2024
Who can take part
To participate in this study, participants must be:
- 50-87 years of age inclusive
- Gradual and progressive change in memory function for 6 months or longer
- Received a diagnosis of mild / early stage Alzheimer’s dementia
- Must have a carer / study partner to attend study visits
What's involved
Participation will involve taking the treatment for 52 weeks, and attending 7 scheduled clinic visits.
The procedures that will occur over the duration of the study include:
- MRI brain scan (once at initial screening visit)
- Medical and physical 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.