TY - JOUR
T1 - NILVAD protocol
T2 - A European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease
AU - Lawlor, Brian
AU - Kennelly, Sean
AU - O'Dwyer, Sarah
AU - Cregg, Fiona
AU - Walsh, Cathal
AU - Coen, Robert
AU - Kenny, Rose Anne
AU - Howard, Robert
AU - Murphy, Caroline
AU - Adams, Jessica
AU - Daly, Leslie
AU - Segurado, Ricardo
AU - Gaynor, Siobhan
AU - Crawford, Fiona
AU - Mullan, Michael
AU - Lucca, Ugo
AU - Banzi, Rita
AU - Pasquier, Florence
AU - Breuilh, Laetitia
AU - Riepe, Matthias
AU - Kalman, Janos
AU - Wallin, Anders
AU - Borjesson, Anne
AU - Molloy, William
AU - Tsolaki, Magda
AU - Olde Rikkert, Marcel
N1 - Publisher Copyright:
© 2014, BMJ Publishing Group. All rights reserved.
PY - 2014
Y1 - 2014
N2 - Introduction: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks. Methods and analysis: Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease and Related Disorders Association (NINCDSADRDA) criteria, will be included in the study. It aims to recruit a total of 500 patients with AD; 250 in the nilvadipine group and 250 in the placebo group. Participants will be randomised to receive nilvadipine, an 8 mg overencapsulated, sustained release capsule, or a matching overencapsulated placebo (sugar pill) for a period of 78 weeks of treatment. The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer's disease Assessment Scale (ADASCog 12) from baseline to the end of treatment duration (78 weeks). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDRsb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDRsb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis. Ethics and dissemination: The study and all subsequent amendments have received ethical approval within each participating country according to national regulations. Each participant will provide written consent to participate in the study. All participants will remain anonymised throughout and the results of the study will be published in an international peerreviewed journal. Trial registration number EUDRACT Reference Number: 201200276427.
AB - Introduction: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82 weeks with a treatment period of 78 weeks. Methods and analysis: Adult patients, males and females over 50 years with mild-to-moderate AD as defined by the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's disease and Related Disorders Association (NINCDSADRDA) criteria, will be included in the study. It aims to recruit a total of 500 patients with AD; 250 in the nilvadipine group and 250 in the placebo group. Participants will be randomised to receive nilvadipine, an 8 mg overencapsulated, sustained release capsule, or a matching overencapsulated placebo (sugar pill) for a period of 78 weeks of treatment. The primary efficacy outcome measure in this study is the change in cognitive function as assessed by the Alzheimer's disease Assessment Scale (ADASCog 12) from baseline to the end of treatment duration (78 weeks). There are two key secondary outcome measures, the Clinical Dementia Rating Scale Sum of Boxes (CDRsb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDRsb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis. Ethics and dissemination: The study and all subsequent amendments have received ethical approval within each participating country according to national regulations. Each participant will provide written consent to participate in the study. All participants will remain anonymised throughout and the results of the study will be published in an international peerreviewed journal. Trial registration number EUDRACT Reference Number: 201200276427.
UR - http://www.scopus.com/inward/record.url?scp=84911435297&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2014-006364
DO - 10.1136/bmjopen-2014-006364
M3 - Article
C2 - 25300460
AN - SCOPUS:84911435297
SN - 2044-6055
VL - 4
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e006364
ER -
