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A phase IIa clinical trial of VEL015 (sodium selenate) in mild to moderate Alzheimer's Disease

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001200976
Enrollment
40
Registered
2011-11-22
Start date
2011-11-16
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

sodium selenate oral capsule 24 weeks treatment Arm 1: 320 mcg three time per day Arm2: 10mg three time per day

Sponsors

Velacor Therapeutics
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

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

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026