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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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001218381
Acronym
SEL001
Enrollment
12
Registered
2017-08-21
Start date
2017-08-24
Completion date
2019-11-13
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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.

Sponsors

Melbourne Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
35 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 25, 2026