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Trial registered on ANZCTR


Registration number
ACTRN12611001200976
Ethics application status
Approved
Date submitted
21/05/2009
Date registered
22/11/2011
Date last updated
23/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A phase IIa clinical trial of VEL015 (sodium selenate) in mild to moderate Alzheimer's Disease
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and the Biological and Cognitive Effects of VEL015 (Sodium Selenate) in Patients with Mild to Moderate Alzheimer’s Disease – a Pilot Study
Secondary ID [1] 273409 0
Velacor002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to Moderate Alzheimer's Disease 4832 0
Condition category
Condition code
Neurological 237175 237175 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
sodium selenate
oral capsule
24 weeks treatment
Arm 1: 320 mcg three time per day
Arm2: 10mg three time per day
Intervention code [1] 4611 0
Treatment: Drugs
Comparator / control treatment
placebo
sugar pill
oral capsule
24 weeks treatment
Control group
Placebo

Outcomes
Primary outcome [1] 237993 0
Safety & Tolerability- adverse events, vital signs, physical and
neurological examination, laboratory evaluations, ECG

Examples of possible adverse events:

Fatigue
Muscle spasms (cramping)
Alopecia
Nail disorders
Nausea
Diarrhoea
Decreased appetite
Lethargy
Dizziness
Vomiting
Timepoint [1] 237993 0
24 weeks after commencement of treatment and 4 weeks after last dose of treatment
Secondary outcome [1] 242123 0
Changes to Alzheimer's Disease biomarkers in the cerebrospinal fluid
Timepoint [1] 242123 0
24 weeks after commencing treatment
Secondary outcome [2] 242124 0
Effects on cognition as measured by Alzheimer's Disease Assessment Scale Cognitive Sub-scale, Mini Mental State Examination, Cogstate test and components of the Neuropsychological Test Battery
Timepoint [2] 242124 0
24 weeks after commencing treatment
Secondary outcome [3] 242125 0
Effect on atrophy of structures in the temporal lobe as determined by Magnetic Resonance Imaging and on the regional cerebral metabolic rate for glucose as determined by Fludeoxyglucose-Positron Emission Tomography
Timepoint [3] 242125 0
24 weeks after commencing treatment

Eligibility
Key inclusion criteria
Modified Hachinski Ischaemia Score of 4 or less
MMSE between 12-26
Acetylcholine esterase inhibitor (AChEI) treatment on a stable dose for at least 4mths
Living in the community with access to a carer
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Treatment with memantine
Serious chronic uncontrolled disease other than Alzheimer's disease
Neurological illness that could contribute to non-Alzheimer's disease dementia
Epilepsy
Diabetes
Familial history of Alzheimer's Disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
During the treatment period, subjects will be randomised to receive sodium selenate (VEL015 10 mg tds [total of 30 mg daily]), VEL015 320 mcg tds [total 960 mcg daily] or or placebo tds in a ratio of 2 to 1 to 1 respectively. Subjects will be randomised on Day 0 (Visit 2). At the time of randomisation, the subject will be assigned a unique Randomisation Number, which will be allocated in ascending order of random numbers based on the predetermined randomisation schedule, and according to their chronological order of inclusion in the study. Subjects will then be allocated a corresponding treatment kit labelled with the same treatment number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be prepared by a statistician prior to the start of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4742 0
3050
Recruitment postcode(s) [2] 4745 0
3065
Recruitment postcode(s) [3] 4743 0
3128
Recruitment postcode(s) [4] 4744 0
3162

Funding & Sponsors
Funding source category [1] 4991 0
Commercial sector/Industry
Name [1] 4991 0
Velacor Therapeutics
Address [1] 4991 0
Level 2, 88 Collin Street, Melbourne, 3000, Victoria
Country [1] 4991 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Velacor Therapeutics
Address
Level 2, 88 Collin Street, Melbourne, 3000, Victoria
Country
Australia
Secondary sponsor category [1] 4514 0
None
Name [1] 4514 0
Address [1] 4514 0
Country [1] 4514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7093 0
Melbourne Health
Ethics committee address [1] 7093 0
Grattan Street, Parkville 3050, Victoria
Ethics committee country [1] 7093 0
Australia
Date submitted for ethics approval [1] 7093 0
10/10/2011
Approval date [1] 7093 0
04/11/2011
Ethics approval number [1] 7093 0
HREC/10/MH/5

Summary
Brief summary
The two hallmark neuropathological features of Alzheimer's disease are extracellular amyloid deposits, and intracellular deposits of neurofibrilliary tangles comprised of abnormal tau protein. The clinical trial of amyloid therapies have been disappointing and this clinical trial represents the first trial of a therapy directed towards tau pathology in Australia to our knowledge.

Everyone has a naturally occurring protein called tau in the brain and the fluid around their brain and spine (cerebrospinal fluid). There is a link between Alzheimer’s Disease and a reaction involving tau where too much phosphate is attached. This may cause brain cells to work less well or die. Further, protein phosphatase 2A (PP2A) which breaks down phosphate has been shown to be less active in people with Alzheimer’s. VEL015 works by increasing the activity of PP2A and therefore decreasing the available phosphate in the brain. Studies in animals have shown that VEL015 helps to prevent this reaction between tau and phosphate. We now want to find out if it will help to treat Alzheimer’s Disease in humans.
Trial website
not available
Trial related presentations / publications
van Eeersel et al., Sodium selenate mitigates tau pathology, neurodegeneration, and functional deficits in Alzheimer’s disease models. PNAS (2010) www.pnas.org/cgi/doi/10.1073/pnas.1009038107

Corcoran NM et al. Sodium selenate specifically activates PP2A phosphatase, dephosphorylates tau and reverses memory deficits in an Alzheimer’s disease model. J Clin Neurosci (2010), doi:10.1016/j.jocn.2010.04.020

Corcoran et al., Open-label, phase I dose-escalation study of sodium selenate, a novel activator of PP2A, in patients with castration-resistant prostate cancer. British Journal of Cancer (2010) 103, 462 – 468
Public notes

Contacts
Principal investigator
Name 29631 0
Address 29631 0
Country 29631 0
Phone 29631 0
Fax 29631 0
Email 29631 0
Contact person for public queries
Name 12878 0
Grant Morley
Address 12878 0
Level 2, 88 Collins Street, Melbourne, Vic, 3000
Country 12878 0
Australia
Phone 12878 0
+61 (0)407 502 574
Fax 12878 0
Email 12878 0
velacor@bigpond.com
Contact person for scientific queries
Name 3806 0
Grant Morley
Address 3806 0
Level 2, 88 Collins Street, Melbourne, Vic, 3000
Country 3806 0
Australia
Phone 3806 0
+61 (0)407 502 574
Fax 3806 0
Email 3806 0
velacor@bigpond.com

No information has been provided regarding IPD availability
Summary results
No Results