Type

Journal Article

Authors

Brian Lawlor
Siobhan Gaynor
Jessica Adams
Robert Howard
Magda Tsolaki
William Molloy
Janos Kalman
Matthias Riepe
Laetitia Breuilh
Florence Pasquier
and 20 others

Subjects

Psychiatry

Topics
controlled trial pathology nilvad study alzheimer disease apolipoprotein apoe nilvad trial nilvadipine genetic markers alzheimer s disease blood flow cerebrospinal fluid double blind ethical approval neuroscience informed consent fluid flow ageing

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. (2016)

Abstract 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. 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. 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. EUDRACT 2012-002764-27; Pre-results.
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Full list of authors on original publication

Brian Lawlor, Siobhan Gaynor, Jessica Adams, Robert Howard, Magda Tsolaki, William Molloy, Janos Kalman, Matthias Riepe, Laetitia Breuilh, Florence Pasquier and 20 others

Experts in our system

1
Brian A. Lawlor
National College Ireland
Total Publications: 125