Journal article
A phase iia randomized control trial of VEL015 (sodium selenate) in mild-moderate Alzheimer's disease
CB Malpas, L Vivasha, S Genc, MM Saling, P Desmond, C Steward, RJ Hicks, J Callahan, A Brodtmann, S Collins, S MacFarlane, NM Corcoran, CM Hovens, D Velakoulis, TJ O'Brien
Journal of Alzheimer S Disease | IOS PRESS | Published : 2016
DOI: 10.3233/JAD-160544
Abstract
Background: There is increasing interest in targeting hyperphosphorylated tau (h-tau) as a disease modifying approach for Alzheimer's disease (AD). Sodium selenate directly stimulates the activity of PP2A, the main enzyme responsible for h-tau dephosphorylation in the brain. Objective: This study assessed the safety and tolerability of 24-week treatment with VEL015 (sodium selenate) in AD. Investigating the effects of VEL015 on cognitive, CSF, and neuroimaging biomarkers of AD were secondary, exploratory objectives. Data were used to identify biomarkers showing most promise for use in subsequent efficacy trials. Methods: A 24-week, multicenter, Phase IIa, double-blinded randomized controlled..
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Funding Acknowledgements
The authors would like to thank the patients and their caregivers for participating in this study. We also thank the research staff at the various clinical sites: Anthony Ang, Jennifer Bortoli, Darren Germaine, Christopher Godden, Jack Germaine, Sean Hosking, Lucas Litewka, Elaine Lui, David Murphy, and Zofia Ross. Charles Malpas is the recipient of an Alzheimer's Australia Viertel Foundation postgraduate research scholarship. This study was funded by Velacor Therapeutics. The data were analyzed, and manuscript written, independently by the authors.