title: NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  EUDRACT Reference Number: 2012-002764-27.
authors.affiliation: Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.
authors.forename: Brian
authors.initials: B
authors.lastname: Lawlor
authors.affiliation: Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.
authors.forename: Sean
authors.initials: S
authors.lastname: Kennelly
authors.affiliation: Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.
authors.forename: Sarah
authors.initials: S
authors.lastname: O'Dwyer
authors.affiliation: Trinity College Dublin (TCD), Dublin, Ireland.
authors.forename: Fiona
authors.initials: F
authors.lastname: Cregg
authors.affiliation: Trinity College Dublin (TCD), Dublin, Ireland.
authors.forename: Cathal
authors.initials: C
authors.lastname: Walsh
authors.affiliation: Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.
authors.forename: Robert
authors.initials: R
authors.lastname: Coen
authors.affiliation: Mercer's Institute for Research on Ageing, St. James's Hospital, Dublin, Ireland.
authors.forename: Rose Anne
authors.initials: RA
authors.lastname: Kenny
authors.affiliation: King's College London (KCL), London, UK.
authors.forename: Robert
authors.initials: R
authors.lastname: Howard
authors.affiliation: King's College London (KCL), London, UK.
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.affiliation: King's College London (KCL), London, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Adams
authors.affiliation: University College Dublin (UCD), Dublin, Ireland.
authors.forename: Leslie
authors.initials: L
authors.lastname: Daly
authors.affiliation: University College Dublin (UCD), Dublin, Ireland.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Segurado
authors.affiliation: Molecular Medicine Ireland (MMI), Dublin, Ireland.
authors.forename: Siobhan
authors.initials: S
authors.lastname: Gaynor
authors.affiliation: Archer Pharmaceuticals Inc, 2040 Whitefield Avenue, Sarasota, Florida, USA.
authors.forename: Fiona
authors.initials: F
authors.lastname: Crawford
authors.affiliation: Archer Pharmaceuticals Inc, 2040 Whitefield Avenue, Sarasota, Florida, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Mullan
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri" (IRFMN), Milan, Italy.
authors.forename: Ugo
authors.initials: U
authors.lastname: Lucca
authors.affiliation: IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri" (IRFMN), Milan, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Banzi
authors.affiliation: Centre Hospitalier Regional et Universitaire de Lille (CHRU- LILLE), Lille, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Pasquier
authors.affiliation: Centre Hospitalier Regional et Universitaire de Lille (CHRU- LILLE), Lille, France.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Breuilh
authors.affiliation: Universitaet Ulm, (UULM), Ulm, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Riepe
authors.affiliation: Szegedi Tudomanyegyetem (SZEGED), Szeged, Hungary.
authors.forename: Janos
authors.initials: J
authors.lastname: Kalman
authors.affiliation: Göteborgs Universitet (UGOT), Gothenburg, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Wallin
authors.affiliation: Göteborgs Universitet (UGOT), Gothenburg, Sweden.
authors.forename: Anne
authors.initials: A
authors.lastname: Borjesson
authors.affiliation: University College Cork (UCC), Cork, Ireland.
authors.forename: William
authors.initials: W
authors.lastname: Molloy
authors.affiliation: Aristotle University of Thessaloniki (AUTH), Greece.
authors.forename: Magda
authors.initials: M
authors.lastname: Tsolaki
authors.affiliation: Radboud Alzheimer Centre; Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Marcel
authors.initials: M
authors.lastname: Olde Rikkert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D002121:Calcium Channel Blockers; C035100:nilvadipine; D009543:Nifedipine
keywords: GERIATRIC MEDICINE