Cookies?
Library Header Image
LSE Research Online LSE Library Services

A randomised controlled trial of calcium channel blockade (CCB) with amlodipine for the treatment of subcortical ischaemic vascular dementia (AFFECT): study protocol

Greenan, Caroline and Murphy, Lynn and Yu, Ly-Mee and Kehoe, Patrick G. and Coulthard, Elizabeth and Bath, Philip and Stewart, Robert and Jones, Rob and Corbett, Anne and Thomas, Alan and Connelly, Peter and Arrojo, Frank and Canning, Rachel and Wallach, Sylvia and Henderson, Catherine and McGuinness, Bernadette and O’Sullivan, Mike and Holmes, Clive and Knapp, Martin and Ballard, Clive and Passmore, Peter (2016) A randomised controlled trial of calcium channel blockade (CCB) with amlodipine for the treatment of subcortical ischaemic vascular dementia (AFFECT): study protocol. Trials, 17 (1). ISSN 1745-6215

[img]
Preview
PDF - Published Version
Available under License Creative Commons Attribution.

Download (907kB) | Preview

Identification Number: 10.1186/s13063-016-1449-3

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.

Item Type: Article
Official URL: https://trialsjournal.biomedcentral.com/
Additional Information: © 2016 The Authors © CC BY 4.0
Subjects: R Medicine > RM Therapeutics. Pharmacology
Sets: Research centres and groups > Personal Social Services Research Unit (PSSRU)
Date Deposited: 03 Aug 2016 08:40
Last Modified: 20 Sep 2017 14:14
URI: http://eprints.lse.ac.uk/id/eprint/67332

Actions (login required)

View Item View Item

Downloads

Downloads per month over past year

View more statistics