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.authorMeulenbroek, Olga
dc.contributor.authorO'Dwyer, Sarah
dc.contributor.authorde Jong, Daan
dc.contributor.authorvan Spijker, Gerrita
dc.contributor.authorKennelly, Sean
dc.contributor.authorCregg, Fiona
dc.contributor.authorOlde Rikkert, Marcel
dc.contributor.authorAbdullah, Laila
dc.contributor.authorWallin, Anders
dc.contributor.authorWalsh, Cathal
dc.contributor.authorCoen, Robert
dc.contributor.authorKenny, Rose Anne
dc.contributor.authorDaly, Leslie
dc.contributor.authorSegurado, Ricardo
dc.contributor.authorBorjesson-Hanson, Anne
dc.contributor.authorCrawford, Fiona
dc.contributor.authorMullan, Michael
dc.contributor.authorLucca, Ugo
dc.contributor.authorBanzi, Rita
dc.contributor.authorPasquier, Florence
dc.contributor.authorBreuilh, Laetitia
dc.contributor.authorRiepe, Matthias
dc.contributor.authorKalman, Janos
dc.contributor.authorMolloy, D. William
dc.contributor.authorTsolaki, Magda
dc.contributor.authorHoward, Robert
dc.contributor.authorAdams, Jessica
dc.contributor.authorGaynor, Siobhan
dc.contributor.authorLawlor, Brian A.
dc.contributor.funderAlzheimer's Drug Discovery Foundation
dc.contributor.funderDutch Alzheimer Society
dc.contributor.funderSeventh Framework Programme
dc.date.accessioned2017-06-22T13:55:54Z
dc.date.available2017-06-22T13:55:54Z
dc.date.issued2016-05-04
dc.description.abstractIntroduction: 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.sponsorshipAlzheimer's Drug Discovery Foundation (20121210); Dutch Alzheimer Society (WE.03-2015-01)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleide011584
dc.identifier.citationMeulenbroek, 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-2016-011584en
dc.identifier.doi10.1136/bmjopen-2016-011584
dc.identifier.endpage13
dc.identifier.issn2044-6055
dc.identifier.issued7
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpage1
dc.identifier.urihttps://hdl.handle.net/10468/4172
dc.identifier.volume6
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.relation.projectinfo: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
dc.relation.urihttp://bmjopen.bmj.com/content/6/7/e011584
dc.rightsPublished 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.urihttps://creativecommons.org/licenses/by-nc/4.0/en
dc.subjectNILVAD studyen
dc.subjectNilvadipineen
dc.subjectAlzheimer's diseaseen
dc.subjectApolipoprotein (APOE)en
dc.subjectPathologyen
dc.subjectGenetic markersen
dc.titleEuropean 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 flowen
dc.typeArticle (peer-reviewed)en
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