ANZCTR - Registration

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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]

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

Condition category

Condition code

Neurological

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]

Treatment: Drugs

Comparator / control treatment

placebo
sugar pill
oral capsule
24 weeks treatment

Control group

Placebo

Outcomes

Primary outcome [1]

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]

24 weeks after commencement of treatment and 4 weeks after last dose of treatment

Secondary outcome [1]

Changes to Alzheimer's Disease biomarkers in the cerebrospinal fluid

Timepoint [1]

24 weeks after commencing treatment

Secondary outcome [2]

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]

24 weeks after commencing treatment

Secondary outcome [3]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

16/11/2011

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]

3050

Recruitment postcode(s) [2]

3128

Recruitment postcode(s) [3]

3162

Recruitment postcode(s) [4]

3065

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Velacor Therapeutics

Address [1]

Level 2, 88 Collin Street, Melbourne, 3000, Victoria

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health

Ethics committee address [1]

Grattan Street, Parkville 3050, Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/10/2011

Approval date [1]

04/11/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Grant Morley

Address

Level 2, 88 Collins Street, Melbourne, Vic, 3000

Country

Australia

Phone

+61 (0)407 502 574

Fax

velacor@bigpond.com

Contact person for scientific queries

Name

Grant Morley

Address

Level 2, 88 Collins Street, Melbourne, Vic, 3000

Country

Australia

Phone

+61 (0)407 502 574

Fax

velacor@bigpond.com

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	A phase iia randomized control trial of VEL015 (sodium selenate) in mild-moderate Alzheimer's disease.	2016	https://dx.doi.org/10.3233/JAD-160544
Embase	Current Research Therapeutic Strategies for Alzheimer's Disease Treatment.	2016	https://dx.doi.org/10.1155/2016/8501693
Embase	Tau-targeting therapies for Alzheimer disease.	2018	https://dx.doi.org/10.1038/s41582-018-0013-z
Embase	Current and Emerging Pharmacological Targets for the Treatment of Alzheimer's Disease.	2019	https://dx.doi.org/10.3233/JAD-190744
Embase	Supranutritional Sodium Selenate Supplementation Delivers Selenium to the Central Nervous System: Results from a Randomized Controlled Pilot Trial in Alzheimer's Disease.	2019	https://dx.doi.org/10.1007/s13311-018-0662-z
Embase	Small molecule therapeutics for tauopathy in Alzheimer's disease: Walking on the path of most resistance.	2021	https://dx.doi.org/10.1016/j.ejmech.2020.112915
Embase	The Role of Dietary Antioxidants and Their Potential Mechanisms in Alzheimer's Disease Treatment.	2023	https://dx.doi.org/10.3390/metabo13030438

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically