Investigating sodium selenate as a treatment for behavioural variant frontotemporal dementia
A Phase 2b Randomised Controlled Trial of Sodium Selenate as a Disease Modifying Treatment for Possible Behavioural Variant Fronto-temporal Dementia
Alfred Health
120 participants
Aug 17, 2021
Interventional
Conditions
Summary
This study will investigate a new drug, sodium selenate, for the treatment of behavioural variant frontotemporal dementia (bvFTD). Up to 120 patients with bvFTD will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in brain volume over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the levels of tau (a protein involved in the development of bvFTD) in the cerebrospinal fluid, the rate of cognitive decline and changes in behavioural symptoms observed in patients over the 52 weeks of treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Sodium selenate (15 mg three times a day) 52 weeks oral tablet. Participants will be asked to return unused medications at clinic visits, which will be counted by study personnel to measure compliance. Telephone calls during the early part of the trial will be made to remind participants/study partners of dosing regimen to ensure participant's are taking the medication as instructed.
Locations(5)
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ACTRN12620000236998