NILVAD protocol

a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease

Brian Lawlor, Sean Kennelly, Sarah O'Dwyer, Fiona Cregg, Cathal Walsh, Robert Coen, Rose A nne Kenny, Robert Howard, Caroline Murphy, Jessica Adams, Leslie Daly, Ricardo Segurado, Siobhan Gaynor, Fiona Crawford, Michael Mullan, Ugo Lucca, Rita Banzi, Florence Pasquier, Laetitia Breuilh, Matthias Riepe & 6 others Janos Kalman, Anders Wallin, Anne Borjesson, William Molloy, Magda Tsolaki, Marcel Olde Rikkert

Research output: Contribution to journalArticle

Abstract

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 (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.

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 peer-reviewed journal.

TRIAL REGISTRATION NUMBER: EUDRACT Reference Number: 2012-002764-27.

Original languageEnglish
Pages (from-to)e006364
JournalBMJ Open
Volume4
Issue number10
DOIs
Publication statusPublished - 2014

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nilvadipine
Alzheimer Disease
Placebos
Dementia
National Institute of Neurological Disorders and Stroke
Outcome Assessment (Health Care)
Communication Disorders
Therapeutics
Cognition
Capsules
Safety

Keywords

  • GERIATRIC MEDICINE

ASJC Scopus subject areas

  • Medicine(all)

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NILVAD protocol : a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease. / Lawlor, Brian; Kennelly, Sean; O'Dwyer, Sarah; Cregg, Fiona; Walsh, Cathal; Coen, Robert; Kenny, Rose A nne; Howard, Robert; Murphy, Caroline; Adams, Jessica; Daly, Leslie; Segurado, Ricardo; Gaynor, Siobhan; Crawford, Fiona; Mullan, Michael; Lucca, Ugo; Banzi, Rita; Pasquier, Florence; Breuilh, Laetitia; Riepe, Matthias; Kalman, Janos; Wallin, Anders; Borjesson, Anne; Molloy, William; Tsolaki, Magda; Olde Rikkert, Marcel.

In: BMJ Open, Vol. 4, No. 10, 2014, p. e006364.

Research output: Contribution to journalArticle

Lawlor, B, Kennelly, S, O'Dwyer, S, Cregg, F, Walsh, C, Coen, R, Kenny, RAN, Howard, R, Murphy, C, Adams, J, Daly, L, Segurado, R, Gaynor, S, Crawford, F, Mullan, M, Lucca, U, Banzi, R, Pasquier, F, Breuilh, L, Riepe, M, Kalman, J, Wallin, A, Borjesson, A, Molloy, W, Tsolaki, M & Olde Rikkert, M 2014, 'NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease', BMJ Open, vol. 4, no. 10, pp. e006364. https://doi.org/10.1136/bmjopen-2014-006364
Lawlor, Brian ; Kennelly, Sean ; O'Dwyer, Sarah ; Cregg, Fiona ; Walsh, Cathal ; Coen, Robert ; Kenny, Rose A nne ; Howard, Robert ; Murphy, Caroline ; Adams, Jessica ; Daly, Leslie ; Segurado, Ricardo ; Gaynor, Siobhan ; Crawford, Fiona ; Mullan, Michael ; Lucca, Ugo ; Banzi, Rita ; Pasquier, Florence ; Breuilh, Laetitia ; Riepe, Matthias ; Kalman, Janos ; Wallin, Anders ; Borjesson, Anne ; Molloy, William ; Tsolaki, Magda ; Olde Rikkert, Marcel. / NILVAD protocol : a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease. In: BMJ Open. 2014 ; Vol. 4, No. 10. pp. e006364.
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AU - Lawlor, Brian

AU - Kennelly, Sean

AU - O'Dwyer, Sarah

AU - Cregg, Fiona

AU - Walsh, Cathal

AU - Coen, Robert

AU - Kenny, Rose A nne

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

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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 (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.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 peer-reviewed journal.TRIAL REGISTRATION NUMBER: EUDRACT Reference Number: 2012-002764-27.

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