European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease - The substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow

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dc.contributor.author Meulenbroek, Olga
dc.contributor.author O'Dwyer, Sarah
dc.contributor.author de Jong, Daan
dc.contributor.author van Spijker, Gerrita
dc.contributor.author Kennelly, Sean
dc.contributor.author Cregg, Fiona
dc.contributor.author Olde Rikkert, Marcel
dc.contributor.author Abdullah, Laila
dc.contributor.author Wallin, Anders
dc.contributor.author Walsh, Cathal
dc.contributor.author Coen, Robert
dc.contributor.author Kenny, Rose Anne
dc.contributor.author Daly, Leslie
dc.contributor.author Segurado, Ricardo
dc.contributor.author Borjesson-Hanson, Anne
dc.contributor.author Crawford, Fiona
dc.contributor.author Mullan, Michael
dc.contributor.author Lucca, Ugo
dc.contributor.author Banzi, Rita
dc.contributor.author Pasquier, Florence
dc.contributor.author Breuilh, Laetitia
dc.contributor.author Riepe, Matthias
dc.contributor.author Kalman, Janos
dc.contributor.author Molloy, D. William
dc.contributor.author Tsolaki, Magda
dc.contributor.author Howard, Robert
dc.contributor.author Adams, Jessica
dc.contributor.author Gaynor, Siobhan
dc.contributor.author Lawlor, Brian A.
dc.date.accessioned 2017-06-22T13:55:54Z
dc.date.available 2017-06-22T13:55:54Z
dc.date.issued 2016-05-04
dc.identifier.citation Meulenbroek, O., O'Dwyer, S., de Jong, D., van Spijker, G., Kennelly, S., Cregg, F., Olde Rikkert, M., Abdullah, L., Wallin, A., Walsh, C., Coen, R., Kenny, R. A., Daly, L., Segurado, R., Borjesson-Hanson, A., Crawford, F., Mullan, M., Lucca, U., Banzi, R., Pasquier, F., Breuilh, L., Riepe, M., Kalman, J., Molloy, W., Tsolaki, M., Howard, R., Adams, J., Gaynor, S. and Lawlor, B. (2016) 'European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease—the substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow', BMJ Open, 6(7) e011584 (13pp). doi: 10.1136/bmjopen-2016-011584 en
dc.identifier.volume 6
dc.identifier.issued 7
dc.identifier.startpage 1
dc.identifier.endpage 13
dc.identifier.issn 2044-6055
dc.identifier.uri http://hdl.handle.net/10468/4172
dc.identifier.doi 10.1136/bmjopen-2016-011584
dc.description.abstract Introduction: In conjunction with the NILVAD trial, a European Multicentre Double-Blind Placebo Controlled trial of Nilvadipine in Mild-to-Moderate Alzheimer's disease (AD), there are four NILVAD substudies in which eligible NILVAD patients are also invited to participate. The main NILVAD protocol was previously published in BMJ Open (2014). The objectives of the NILVAD substudies are to determine whether frailty, cerebrospinal fluid (CSF), blood biomarker profile and Apolipoprotein E (APOE) status predict response to Nilvadipine, and to investigate the effect of Nilvadipine on cerebral blood flow and blood biomarkers. Methods and analysis: All participants who fulfil criteria for the main NILVAD study are eligible for participation in the NILVAD substudies. Participation is subject to informed consent and whether the substudy is available at a particular NILVAD study site. Each substudy entails extra measurements during the course of the main NILVAD study. For example, in the blood and genetic biomarkers substudy, extra blood (30 mL) will be collected at week 0, week 13, week 52 and week 78, while in the cerebral blood flow substudy, participants will receive an MRI and transcranial Doppler measurements at week 0, week 26 and week 78. In the CSF substudy, 10 mL CSF is collected at week 0 and week 78. Ethics and dissemination: All NILVAD substudies and all subsequent amendments have received ethical approval within each participating country, according to national regulations. Each participant provides written consent to participate. All participants remain anonymised throughout and the results of each substudy will be published in an international peer reviewed journal. Trial registration number EUDRACT 2012-002764-27; Pre-results. en
dc.description.sponsorship Alzheimer's Drug Discovery Foundation (20121210); Dutch Alzheimer Society (WE.03-2015-01) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher BMJ Publishing Group en
dc.relation.uri http://bmjopen.bmj.com/content/6/7/e011584
dc.rights Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ en
dc.rights.uri https://creativecommons.org/licenses/by-nc/4.0/ en
dc.subject NILVAD study en
dc.subject Nilvadipine en
dc.subject Alzheimer's disease en
dc.subject Apolipoprotein (APOE) en
dc.subject Pathology en
dc.subject Genetic markers en
dc.title European multicentre double-blind placebo-controlled trial of Nilvadipine in mild-to-moderate Alzheimer's disease - The substudy protocols: NILVAD frailty; NILVAD blood and genetic biomarkers; NILVAD cerebrospinal fluid biomarkers; NILVAD cerebral blood flow en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother William Molloy, Centre for Gerontology and Rehabilitation, Medicine, University College Cork, Cork, Ireland. +353-21-490-3000 Email: w.molloy@ucc.ie en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.contributor.funder Alzheimer's Drug Discovery Foundation
dc.contributor.funder Dutch Alzheimer Society
dc.contributor.funder Seventh Framework Programme
dc.description.status Peer reviewed en
dc.identifier.journaltitle BMJ Open en
dc.internal.IRISemailaddress w.molloy@ucc.ie en
dc.identifier.articleid e011584
dc.relation.project info:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/279093/EU/A European multicentre double-blind placebo-controlled phase III trial of nilvadIpine in mild to moderate Alzheimer’s disease/NILVAD


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Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ Except where otherwise noted, this item's license is described as Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
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