A Phase 2b randomised controlled trial of sodium selenate as a disease modifying treatment for probable behavioural variant fronto-temporal dementia

Currently there are no approved treatments for fronto-temporal dementia. 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 fronto-temporal 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)
• 3 x PET scans (2 at the beginning and 1 at the completion of the study)
• 2 x Lumbar Punctures (1 at the beginning and 1 at the completion of the study)
• Physical and neurological examinations
• Blood tests
• Cognitive tests and questionnaires