Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16309
Title: A phase IIa randomized control trial of VEL015 (Sodium Selenate) in mild-moderate Alzheimer's disease
Austin Authors: Malpas, Charles B;Vivash, Lucy;Genc, Sila;Saling, Michael M ;Desmond, Patricia;Steward, Christopher;Hicks, Rodney J;Callahan, Jason;Brodtmann, Amy ;Collins, Steven;Macfarlane, Stephen;Corcoran, Niall M;Hovens, Christopher M;Velakoulis, Dennis;O’Brien, Terence J
Affiliation: Melbourne Brain Centre, The Department of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Melbourne, Victoria, Australia
Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia
Department of Neuropsychology, Austin Health, Heidelberg, Victoria, Australia
Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre, Austin Health, Heidelberg, Victoria, Australia
Department of Radiology, University of Melbourne, Melbourne, Victoria, Australia
Department of Radiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Eastern Cognitive Disorders Clinic, Department of Neurology, Eastern Health, Monash University, Melbourne, Victoria, Australia
Department of Surgery, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Caulfield Hospital, Alfred Health, Melbourne, Victoria, Australia
Melbourne Neuropsychiatry Centre, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Department of Psychiatry, Melbourne, Victoria, Australia
Centre for Molecular Imaging, Peter MacCallum Cancer Institute, Melbourne, Victoria, Australia
Department of Medicine, Royal Melbourne Hospital, Melbourne, Victoria, Australia
Department of Clinical Neurosciences and Neurological Research, St Vincent's Hospital, Melbourne, Victoria, Australia
Issue Date: 2016
Publication information: Journal of Alzheimer's Disease 2016; 54(1): 223-232
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 trial. Forty patients aged ≥55 y with mild-moderate AD (MMSE 14–26) were randomized to supranutritional (VEL015 10 mg tds [n = 20]) and control (VEL015 320μg tds [n = 10] or placebo [n = 10]) groups. Patients were regularly monitored for safety, adverse events (AEs), and protocol compliance. Exploratory biomarkers included cognitive tests, neuroimaging (diffusion MR), and CSF (p-tau, t-tau, and Aβ1-42). Results: Thirty-six (90%; [supranutritional n = 18, control/placebo n = 18]) patients completed the trial. There were no differences in the incidence of specific AEs between groups. Only one secondary biomarker, diffusion MR measures, showed group differences, with less deterioration in the supranutritional group (p < 0.05). Conclusion: Treatment with VEL015 at doses up to 30 mg per day for 24 weeks was safe and well-tolerated in patients with AD. Diffusion MR measures appear to be the most sensitive biomarkers to assess disease progression over 24 weeks.
URI: http://ahro.austin.org.au/austinjspui/handle/1/16309
DOI: 10.3233/JAD-160544
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/27447428
Type: Journal Article
Subjects: Alzheimer’s disease
Clinical trial
Dementia
Sodium selenate
Appears in Collections:Journal articles

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