Sodium Selenate as a treatment for patients with possible behavioural-variant Fronto-Temporal Dementia

Phase 1

• Conditions: fronto-temporal dementia; Neurological - Dementias

• Registration Number: ACTRN12617001218381
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-21
• Study Completion: 2021-01-06
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Diagnosis of possible behavioural variant FTD
MRI not inconsistent with FTD
Responsible caregiver who can ensure participants compliance with study procedures and dosing of drug

Exclusion Criteria

Contra-indication to lumbar puncture
Positive amyloid PET scan
Known family history of Alzheimer's Disease
Significant uncontrolled medical condition
Known sensitivity to sodium selenate or related compounds

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of sodium selenate. Participants will be provided a diary card to record solicited (10 most common AEs) and unsolicited AEs as well as missed doses of medication. Safety laboratory tests, 12-lead ECG and physical and neurological examination will also be used to assess safety measures.[Solicited and unsolicited AEs at 13 weeks, 26 weeks and 52 weeks<br>Reason at early discontinuation.]

Secondary Outcome Measures

Name	Time	Method
Assess the effects of sodium selenate on total tau and phospho-tau levels in the CSF [Change in total tau and phospho-tau between baseline and 52 weeks];Assess the effects of sodium selenate on change in neurocognition between baseline and 52 weeks. Scales used - Neuropsychiatry Unit Cognitive Assessment Scale (NUCOG), NIH Executive Function Battery (NIH-EXAMINER), Cambridge Behavioural Inventory - Revised (CBI), California Verbal Learning Test II (CVLT-II), Caregiver Burden Scale (CBS)<br>[Change between baseline and 52 weeks];Assess the effect of sodium selenate on brain atrophy as measured by MRI[Change between baseline and 52 weeks]