Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001218381
Ethics application status
Approved
Date submitted
2/08/2017
Date registered
21/08/2017
Date last updated
5/07/2021
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sodium Selenate as a treatment for patients with possible behavioural-variant Fronto-Temporal Dementia
Scientific title
A Phase 1b Open Labelled Study of Sodium Selenate as a Disease Modifying Treatment for Possible Behavioural Variant Fronto-Temporal Dementia
Secondary ID [1] 292581 0
None
Universal Trial Number (UTN)
Trial acronym
SEL001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fronto-temporal dementia 304251 0
Condition category
Condition code
Neurological 303600 303600 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298784 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302952 0
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.
Timepoint [1] 302952 0
Solicited and unsolicited AEs at 13 weeks, 26 weeks and 52 weeks
Reason at early discontinuation.
Secondary outcome [1] 337545 0
Assess the effects of sodium selenate on total tau and phospho-tau levels in the CSF
Timepoint [1] 337545 0
Change in total tau and phospho-tau between baseline and 52 weeks
Secondary outcome [2] 337546 0
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)
Timepoint [2] 337546 0
Change between baseline and 52 weeks
Secondary outcome [3] 337547 0
Assess the effect of sodium selenate on brain atrophy as measured by MRI
Timepoint [3] 337547 0
Change between baseline and 52 weeks

Eligibility
Key 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
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
24/08/2017
Actual
24/08/2017
Date of last participant enrolment
Anticipated
1/09/2019
Actual
13/11/2019
Date of last data collection
Anticipated
15/01/2021
Actual
6/01/2021
Sample size
Target
15
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8678 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 16789 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 297157 0
Charities/Societies/Foundations
Name [1] 297157 0
RMH Neurosciences Foundation
Country [1] 297157 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Office for Research
Ward 2 South West
Royal Melbourne HOspital
Grattan Street
Parkville
3050
Country
Australia
Secondary sponsor category [1] 296172 0
None
Name [1] 296172 0
Address [1] 296172 0
Country [1] 296172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298324 0
Melbourne Health
Ethics committee address [1] 298324 0
Royal Melbourne Hospital Office for Research, Level 2 South West, 300 Grattan Street, Parkville Victoria 3052
Ethics committee country [1] 298324 0
Australia
Date submitted for ethics approval [1] 298324 0
Approval date [1] 298324 0
18/05/2017
Ethics approval number [1] 298324 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76722 0
Prof Terry O'Brien
Address 76722 0
Department of Neurology
Royal Melbourne Hospital
Grattan Street
Parkville
3050
Country 76722 0
Australia
Phone 76722 0
+613 9342 7722
Fax 76722 0
Email 76722 0
[email protected]
Contact person for public queries
Name 76723 0
Lucy Vivash
Address 76723 0
Department of Neurology
Royal Melbourne Hospital
Grattan Street
Parkville
3050
Country 76723 0
Australia
Phone 76723 0
+613 9342 4420
Fax 76723 0
Email 76723 0
[email protected]
Contact person for scientific queries
Name 76724 0
Lucy Vivash
Address 76724 0
Department of Neurology
Royal Melbourne Hospital
Grattan Street
Parkville
3050
Country 76724 0
Australia
Phone 76724 0
+613 9342 4420
Fax 76724 0
Email 76724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to individual data being made available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA study protocol for a phase II randomised, double-blind, placebo-controlled trial of sodium selenate as a disease-modifying treatment for behavioural variant frontotemporal dementia.2020https://dx.doi.org/10.1136/bmjopen-2020-040100
Dimensions AISodium selenate as a disease-modifying treatment for progressive supranuclear palsy: protocol for a phase 2, randomised, double-blind, placebo-controlled trial2021https://doi.org/10.1136/bmjopen-2021-055019
EmbaseA phase 1b open-label study of sodium selenate as a disease-modifying treatment for possible behavioral variant frontotemporal dementia.2022https://dx.doi.org/10.1002/trc2.12299
EmbasePerivascular spaces as a marker of disease severity and neurodegeneration in patients with behavioral variant frontotemporal dementia.2022https://dx.doi.org/10.3389/fnins.2022.1003522
EmbaseTau-targeting therapies for Alzheimer disease: current status and future directions.2023https://dx.doi.org/10.1038/s41582-023-00883-2
N.B. These documents automatically identified may not have been verified by the study sponsor.