B vitamins and cognition in subjects with small vessel disease: A Substudy of VITATOPS, a randomized, placebo-controlled trial

VITAmins TO Prevent Stroke (VITATOPS) study, a randomized, double-blind international multi-centre trial involving 8164 subjects in studying effect of lowering homocysteine level by daily administration of B-vitamins (2 mg folic acid, 25 mg vitamin B6, and 0.5 mg vitamin B12) failed to demonstrate a positive effect of B-vitamins in reducing incidence of major vascular events and global cognition decline as measured by mini-mental state examination (MMSE) score [ 1 VITATOPS Trial Study Group B vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial. Lancet Neurol. 2010 Sep; 9: 855-865 Abstract Full Text Full Text PDF PubMed Scopus (250) Google Scholar , 2 Hankey G.J. Ford A.H. Yi Q. VITATOPS Trial Study Group et al. Effect of B-vitamins and lowering homocysteine on cognitive impairment in patients with previous stroke or transient ischemic attack: a prespecified secondary analysis of a randomized, placebo-controlled trial and meta-analysis. Stroke. 2013 Aug; 44: 2232-2239 Crossref PubMed Scopus (58) Google Scholar ]. However, assessment of cognition using MMSE alone has its limitations and a full neuropsychological assessment of different cognitive domains will provide more robust evidence. Interestingly, a substudy shows possible positive effect in stabilising severe cerebral small vessel disease (CVSD) [ [3] Cavalieri M. Schmidt R. Chen C. VITATOPS Trial Study Group et al. B vitamins and magnetic resonance imaging-detected ischemic brain lesions in patients with recent transient ischemic attack or stroke: the VITAmins TO Prevent Stroke (VITATOPS) MRI-substudy. Stroke. 2012 Dec; 43: 3266-3270 Crossref PubMed Scopus (65) Google Scholar ]. To address current gaps in knowledge, we conducted a full neuropsychological assessment in a subset of participants with small vessel disease longitudinally over 5 years to assess the long term effects of B-vitamins on cognition.