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

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; AFFECT Investigators; Roy Soiza

doi:10.1186/s13063-016-1449-3

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

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 BallardPeter Passmore, AFFECT Investigators, Roy Soiza

Health Services Research Unit (HSRU)

Research output: Contribution to journal › Article › peer-review

4 Citations (Scopus)

9 Downloads (Pure)

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.

Original language	English
Article number	324
Journal	Trials
Volume	17
DOIs	https://doi.org/10.1186/s13063-016-1449-3
Publication status	Published - 18 Jul 2016

Bibliographical note

The study is funded by the British Heart Foundation and the Alzheimer’s Society (grant number 184). We wish to acknowledge the support from the staff at the Northern Ireland Clinical Trials Unit; Paul Doherty, Nicola Goodfellow, Roisin Boyle, Mark Wilson, Annmarie Doran, Sam Cassidy and the Belfast Health and Social Care Trust; Margaret McFarland, Fiona Taylor.

Keywords

Activities of Daily Living
Amlodipine
Brain Ischemia
Calcium Channel Blockers
Clinical Protocols
Cognition
Dementia, Vascular
Double-Blind Method
Female
Humans
Magnetic Resonance Imaging
Male
Middle Aged
Neuropsychological Tests
Quality of Life
Research Design
Time Factors
Treatment Outcome
United Kingdom
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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10.1186/s13063-016-1449-3Licence: CC BY

A randomised controlled trial of calcium channel blockade
© 2016 Greenan et al. Open Access 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.
Final published version, 759 KBLicence: CC BY

Cite this

Greenan, C., Murphy, L., Yu, L.-M., Kehoe, P. G., Coulthard, E., Bath, P., Stewart, R., Jones, R., Corbett, A., Thomas, A., Connelly, P., Arrojo, F., Canning, R., Wallach, S., Henderson, C., McGuinness, B., O'Sullivan, M., Holmes, C., Knapp, M., ... Soiza, R. (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, Article 324. https://doi.org/10.1186/s13063-016-1449-3

Greenan, C, Murphy, L, Yu, L-M, Kehoe, PG, Coulthard, E, Bath, P, Stewart, R, Jones, R, Corbett, A, Thomas, A, Connelly, P, Arrojo, F, Canning, R, Wallach, S, Henderson, C, McGuinness, B, O'Sullivan, M, Holmes, C, Knapp, M, Ballard, C, Passmore, P, AFFECT Investigators & Soiza, R 2016, 'A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol', Trials, vol. 17, 324. https://doi.org/10.1186/s13063-016-1449-3

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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.",

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author = "Caroline Greenan and Lynn Murphy and Ly-Mee Yu and Kehoe, {Patrick G} and Elizabeth Coulthard and Philip Bath and Robert Stewart and Rob Jones and Anne Corbett and Alan Thomas and Peter Connelly and Frank Arrojo and Rachel Canning and Sylvia Wallach and Catherine Henderson and Bernadette McGuinness and Mike O'Sullivan and Clive Holmes and Martin Knapp and Clive Ballard and Peter Passmore and {AFFECT Investigators} and Roy Soiza",

note = "The study is funded by the British Heart Foundation and the Alzheimer{\textquoteright}s Society (grant number 184). We wish to acknowledge the support from the staff at the Northern Ireland Clinical Trials Unit; Paul Doherty, Nicola Goodfellow, Roisin Boyle, Mark Wilson, Annmarie Doran, Sam Cassidy and the Belfast Health and Social Care Trust; Margaret McFarland, Fiona Taylor. ",

year = "2016",

month = jul,

day = "18",

doi = "10.1186/s13063-016-1449-3",

language = "English",

volume = "17",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central",

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TY - JOUR

T1 - A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT)

T2 - study protocol

AU - Greenan, Caroline

AU - Murphy, Lynn

AU - Yu, Ly-Mee

AU - Kehoe, Patrick G

AU - Coulthard, Elizabeth

AU - Bath, Philip

AU - Stewart, Robert

AU - Jones, Rob

AU - Corbett, Anne

AU - Thomas, Alan

AU - Connelly, Peter

AU - Arrojo, Frank

AU - Canning, Rachel

AU - Wallach, Sylvia

AU - Henderson, Catherine

AU - McGuinness, Bernadette

AU - O'Sullivan, Mike

AU - Holmes, Clive

AU - Knapp, Martin

AU - Ballard, Clive

AU - Passmore, Peter

AU - AFFECT Investigators

AU - Soiza, Roy

N1 - The study is funded by the British Heart Foundation and the Alzheimer’s Society (grant number 184). We wish to acknowledge the support from the staff at the Northern Ireland Clinical Trials Unit; Paul Doherty, Nicola Goodfellow, Roisin Boyle, Mark Wilson, Annmarie Doran, Sam Cassidy and the Belfast Health and Social Care Trust; Margaret McFarland, Fiona Taylor.

PY - 2016/7/18

Y1 - 2016/7/18

N2 - 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.

AB - 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.

KW - Activities of Daily Living

KW - Amlodipine

KW - Brain Ischemia

KW - Calcium Channel Blockers

KW - Clinical Protocols

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KW - Dementia, Vascular

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Magnetic Resonance Imaging

KW - Male

KW - Middle Aged

KW - Neuropsychological Tests

KW - Quality of Life

KW - Research Design

KW - Time Factors

KW - Treatment Outcome

KW - United Kingdom

KW - Clinical Trial, Phase II

KW - Journal Article

KW - Multicenter Study

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1186/s13063-016-1449-3

DO - 10.1186/s13063-016-1449-3

M3 - Article

C2 - 27430267

SN - 1745-6215

VL - 17

JO - Trials

JF - Trials

M1 - 324

ER -

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

Abstract

Bibliographical note

Keywords

Access to Document

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