NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease. Lawlor, B., Kennelly, S., O'Dwyer, S., Cregg, F., Walsh, C., Coen, R., Kenny, R. A., 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. BMJ open, 4(10):e006364, October, 2014.
doi  abstract   bibtex   
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.
@article{lawlor_nilvad_2014,
	title = {{NILVAD} protocol: a {European} multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate {Alzheimer}'s disease},
	volume = {4},
	issn = {2044-6055},
	shorttitle = {{NILVAD} protocol},
	doi = {10.1136/bmjopen-2014-006364},
	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.},
	language = {eng},
	number = {10},
	journal = {BMJ open},
	author = {Lawlor, Brian and Kennelly, Sean and O'Dwyer, Sarah and Cregg, Fiona and Walsh, Cathal and Coen, Robert and Kenny, Rose Anne and Howard, Robert and Murphy, Caroline and Adams, Jessica and Daly, Leslie and Segurado, Ricardo and Gaynor, Siobhan and Crawford, Fiona and Mullan, Michael and Lucca, Ugo and Banzi, Rita and Pasquier, Florence and Breuilh, Laetitia and Riepe, Matthias and Kalman, Janos and Wallin, Anders and Borjesson, Anne and Molloy, William and Tsolaki, Magda and Olde Rikkert, Marcel},
	month = oct,
	year = {2014},
	pmid = {25300460},
	pmcid = {PMC4194801},
	keywords = {Aged, Alzheimer Disease, Humans, Female, Male, Middle Aged, Europe, Aged, 80 and over, Treatment Outcome, Double-Blind Method, Severity of Illness Index, Calcium Channel Blockers, Nifedipine, GERIATRIC MEDICINE},
	pages = {e006364}
}
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