TerminatedPhase 2ACTRN12617001218381

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

A Phase 1b Open Labelled Study of Sodium Selenate as a Disease Modifying Treatment for Possible Behavioural Variant Fronto-Temporal Dementia


Sponsor

Melbourne Health

Enrollment

15 participants

Start Date

Aug 24, 2017

Study Type

Interventional

Conditions

Summary

This study will investigate the safety and tolerability of sodium selenate in patients with behavioural variant frontotemporal dementia. All participants will be given sodium selenate for 52 weeks, and assessed regularly to investigate any negative reactions to the drug, as well as any positive effects on the symptoms of their dementia, as measured by biological samples, cognitive tests and brain scans.


Eligibility

Sex: Both males and femalesMin Age: 35 Yearss

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

Each participant will receive capsules of sodium selenate 15mg three times a day (which may be reduced to 10mg three times a day) for 52 weeks. A dose reduction will be made in the event of intolerabl

Each participant will receive capsules of sodium selenate 15mg three times a day (which may be reduced to 10mg three times a day) for 52 weeks. A dose reduction will be made in the event of intolerable adverse events experienced by the participant at their next scheduled or unscheduled visit as decided by on the the study doctors. Participants/partners will be required to bring unused medications to each visit to measure compliance, as well as recording any missed doses in their study diary.


Locations(1)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

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ACTRN12617001218381


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