Type

Journal Article

Authors

Marcel Olde Rikkert
Magda Tsolaki
William Molloy
Anne Borjesson
Anders Wallin
Janos Kalman
Matthias Riepe
Laetitia Breuilh
Florence Pasquier
Rita Banzi
and 19 others

Subjects

Physiotherapy & Sport

Topics
national institute controlled trial neuroscience 50 years ageing treatment outcome measures geriatric medicine protocol european phase iii alzheimer s disease alzheimer s disease ad ethical approval age related diseases cognitive function double blind nilvad protocol

NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease. (2014)

Abstract 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. 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 (NINCDS-ADRDA) 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 (ADAS-Cog 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 (CDR-sb) and the Disability Assessment for Dementia (DAD). If a statistically significant effect is seen in the primary outcome, CDR-sb will be considered to be a coprimary end point and only the DAD will contribute to the secondary outcome analysis. 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 peer-reviewed journal. EUDRACT Reference Number: 2012-002764-27.
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Full list of authors on original publication

Marcel Olde Rikkert, Magda Tsolaki, William Molloy, Anne Borjesson, Anders Wallin, Janos Kalman, Matthias Riepe, Laetitia Breuilh, Florence Pasquier, Rita Banzi and 19 others

Experts in our system

1
Marcel G. M. Olde Rikkert
University College Cork
Total Publications: 8