Clinical Trials
Clinical trial of a new treatment for BvFTD/PNFA: Monash University
A Phase 2b randomised controlled trial of sodium selenate as a disease modifying treatment for probable behavioural variant frontotemporal dementia and progressive non-fluent aphasia.
Currently there are no approved treatments for frontotemporal dementia. Patients with frontotemporal dementia often have an excess build-up of the protein tau in their brains, sodium selenate, the drug used in this study, acts to reduce the levels of tau in the brain. The main purpose of this research project is to look at whether 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 your brain and spine to see if you are responding to the treatment.
Participation in this study will involve coming to the study doctor’s clinic up to ten 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 (a drug that looks like the study drug but has no active ingredient). 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:
- 2 x MRI scans (1 at the beginning and 1 at the completion of the study)
- 1 x PET scans (at the beginning of the study)
- Physical and neurological examinations
- Blood tests
- Cognitive tests and questionnaires
This study has been approved by the Alfred Hospital Human Research Ethics Committee (project number: 609/19).
Participant duration:
Attending the study doctor’s clinic up to ten times over 64 weeks (15 months)Available to people living in NSW, VIC.
For further information, please email selenate@alfred.org.au or Lucy Vivash lucy.vivash@monash.edu