RecruitingPhase 2ACTRN12620000236998

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


Sponsor

Alfred Health

Enrollment

120 participants

Start Date

Aug 17, 2021

Study Type

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

Sex: Both males and femalesMin Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

Behavioural variant frontotemporal dementia (bvFTD) is a form of dementia that primarily affects personality, behaviour, and decision-making, often striking people in their 50s or 60s. There are currently no approved treatments that slow its progression. This Phase 2 clinical trial is investigating sodium selenate — a compound containing selenium — as a potential treatment that may protect brain cells from the abnormal build-up of a protein called tau, which is thought to drive the disease. Participants are randomly assigned to take either sodium selenate tablets (15mg three times a day) or a placebo for 52 weeks. Researchers measure brain volume changes using MRI, tau levels in the cerebrospinal fluid, cognitive function, and behavioural symptoms over the course of the year. You may be eligible if you are 35 or older with a confirmed or probable diagnosis of bvFTD or a related condition (PNFA), live in the community, and have a carer who spends at least 10 hours a week with you and can help ensure medication compliance. Various conditions including liver or kidney disease, unstable diabetes, or certain medication combinations may affect eligibility. Women of childbearing potential must use effective contraception throughout.

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 complianc

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)

Royal Melbourne Hospital - City campus - Parkville

NSW,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,VIC, Australia

Box Hill Hospital - Box Hill

NSW,VIC, Australia

The Alfred - Melbourne

NSW,VIC, Australia

Auckland, New Zealand

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ACTRN12620000236998