A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2016-07-18

AUTHORS

Caroline Greenan, Lynn Murphy, Ly-Mee Yu, Patrick G. Kehoe, Elizabeth Coulthard, Philip Bath, Robert Stewart, Rob Jones, Anne Corbett, Alan Thomas, Peter Connelly, Frank Arrojo, Rachel Canning, Sylvia Wallach, Catherine Henderson, Bernadette McGuinness, Mike O’Sullivan, Clive Holmes, Martin Knapp, Clive Ballard, Peter Passmore, Peter Passmore, Eric Jackson, Roy Soiza, Peter Connelly, Rob G. Jones, Vanessa Raymont, Latha Velayudhan, Alan Thomas, Rohan Vanderputt, Stephen Pearson, Robert Lawrence, Clive Ballard, Frances Harrington

ABSTRACT

BACKGROUND: Vascular dementia is the second most common cause of dementia affecting over seven million people worldwide, yet there are no licensed treatments. There is an urgent need for a clinical trial in this patient group. Subcortical ischaemic vascular dementia is the most common variant of vascular dementia. This randomised trial will investigate whether use of calcium channel blockade with amlodipine, a commonly used agent, can provide the first evidence-based pharmacological treatment for subcortical ischaemic vascular dementia. METHODS/DESIGN: This is a randomised controlled trial of calcium channel blockade with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT) to test the hypothesis that treatment with amlodipine can improve outcomes for these patients in a phase IIb, multi-centre, double-blind, placebo-controlled randomised trial. The primary outcome is the change from baseline to 12 months in the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog). Secondary outcomes include cognitive function, executive function, clinical global impression of change, change in blood pressure, quantitative evaluation of lesion accrual based on magnetic resonance imaging (MRI), health-related quality of life, activities of daily living, non-cognitive dementia symptoms, care-giver burden and care-giver health-related quality of life, cost-effectiveness and institutionalisation. A total of 588 patients will be randomised in a 1:1 ratio to either amlodipine or placebo, recruited from sites across the UK and enrolled in the trial for 104 weeks. DISCUSSION: There are no treatments licensed for vascular dementia. The most common subtype is subcortical ischaemic vascular dementia (SIVD). This study is designed to investigate whether amlodipine can produce benefits compared to placebo in established SIVD. It is estimated that the numbers of people with VaD and SIVD will increase globally in the future and the results of this study should inform important treatment decisions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN31208535 . Registered on 7 March 2014. More... »

PAGES

324

Journal

TITLE

Trials

ISSUE

1

VOLUME

17

Author Affiliations

  • Northern Ireland Clinical Trials Unit, 1st Floor Elliott Dynes Building, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BA UK
  • Primary Care Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences (Gibson Building), Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG UK
  • Dementia Research Group, Clinical Neurosciences, University of Bristol, Level 1 Learning and Research Building, Bristol, BS10 5NB UK
  • Clinical Sciences Building, Nottingham City Hospital, Hucknall Road, Nottingham, NG5 1PB UK
  • Institute of Psychiatry, Psychology & Neuroscience, King’s College London, 16 De Crespigny Park, London, SE5 8AF UK
  • School of Community Health Sciences, Division of Psychiatry, Institute of Mental Health, University of Nottingham, Innovation Park, Triumph Road, Nottingham, NG7 2TU UK
  • Wolfson CARD, Kings College London, Wolfson Wing, Hodgkin Building, Guy’s Campus, London, SE1 1UL UK
  • Biomedical Research Building, Institute of Neuroscience and Newcastle University Institute for Ageing, Newcastle University, Campus for Ageing and Vitality, Newcastle upon Tyne, NE4 5PL UK
  • Murray Royal Hospital, Muirhall Road, Perth, PH2 7BH UK
  • Research Network Volunteer, Alzheimer’s Society, 58 St Katharine’s Way, London, E1W 1LB UK
  • Personal Social Services Research Unit (PSSRU), London School of Economics, Houghton Street, London, WC2A 2AE UK
  • Centre for Public Health, Institute of Clinical Sciences, Block B, Queen’s University Belfast, The Royal Hospitals, Grosvenor Road, Belfast, BT12 6BA UK
  • Academic Neuroscience Centre, Institute of Psychiatry, De Crespigny Park, PO Box 41, London, SE5 8AF UK
  • MARC, University of Southampton, Moorgreen Hospital, Botley Road, Southampton, S030 3JB UK
  • Wolfson Centre for Age-Related Diseases, King’s College London, Guy’s Campus, London, SE1 1UL UK
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-016-1449-3

    DOI

    http://dx.doi.org/10.1186/s13063-016-1449-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1001506273

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/27430267


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