A trial to test sodium selenate as a disease-modifying treatment for probable behavioural variant frontotemporal dementia (bvFTD).
About this study
The main purpose of this research project is to look at whether the trial drug, sodium selenate decreases the rate of brain shrinkage in patients with frontotemporal dementia.
The research project will also look into the effect of sodium selenate on brain function and markers of disease measured on brain scans, in blood, and in the fluid around the brain and spine to see if participants are responding to the treatment.
Anticipated enrolment close date: March 2024
Contact the Dementia Research Office for more information.
Who can take part
Participants meet the key inclusion criteria:
- Aged 35 years or over
- Modified Hachinski ischaemia score less than or equal to 4
- Diagnosis of possible or probable bvFTD
- Must have at least 10 contact hours per week with a responsible carer
What's involved
Participation in this study will involve coming to the study doctor’s clinic up to 10 times over 64 weeks (15 months).
Participants will be randomised to either the study drug, sodium selenate, or placebo. Half of the participants will receive the study drug, and half will receive the placebo. Neither you nor any of the research team will know whether you are receiving the study drug or the placebo.
The study involves the following assessments:
- Two MRI scans (one at the beginning and one at the completion of the study)
- Three PET scans (2 at the beginning and one at the completion of the study)
- Two lumbar punctures (one at the beginning and one at the completion of the study)
- Physical and neurological examinations
- Blood tests
- 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.