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A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol

Research output: Contribution to journalArticle

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 & 3 more Peter Passmore, AFFECT Investigators, Latha Velayudhan

Original languageEnglish
Pages (from-to)324
JournalTrials
Volume17
Issue number1
DOIs
Publication statusPublished - 18 Jul 2016

Documents

  • A randomised controlled trial_GREENAN_Accepted 6Jun2016_GOLD VoR

    A_randomised_controlled_trial_GREENAN_Accepted_6Jun2016_GOLD_VoR.pdf, 727 KB, application/pdf

    27/07/2016

    Final published version

    CC BY

    This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

King's Authors

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.

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