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Research Article

A Randomised, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial)

  • Clive Ballard mail,

    To whom correspondence should be addressed. E-mail: clive.ballard@kcl.ac.uk

    Affiliation: Wolfson Centre for Age-Related Diseases, King's College London, London, United Kingdom

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  • Marisa Margallo Lana,

    Affiliation: Northgate Hospital, Morpeth, Northumberland, United Kingdom

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  • Megan Theodoulou,

    Affiliation: Department of Psychiatry, University of Oxford, The Warneford Hospital, Oxford, United Kingdom

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  • Simon Douglas,

    Affiliation: Department of Psychiatry, Newcastle University, Newcastle upon Tyne, United Kingdom

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  • Rupert McShane,

    Affiliation: Oxfordshire and Buckinghamshire Mental Health NHS Trust and University of Oxford, Department of Psychiatry, Fulbrook Centre, Oxford, United Kingdom

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  • Robin Jacoby,

    Affiliation: Department of Psychiatry, University of Oxford, The Warneford Hospital, Oxford, United Kingdom

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  • Katja Kossakowski,

    Affiliation: Wolfson Centre for Age-Related Diseases, King's College London, London, United Kingdom

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  • Ly-Mee Yu,

    Affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

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  • Edmund Juszczak,

    Affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

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  • on behalf of the Investigators DART AD
  • Published: April 01, 2008
  • DOI: 10.1371/journal.pmed.0050076

About the Authors

Clive Ballard, Katja Kossakowski
Wolfson Centre for Age-Related Diseases, King's College London, London, United Kingdom
Marisa Margallo Lana
Northgate Hospital, Morpeth, Northumberland, United Kingdom
Megan Theodoulou, Robin Jacoby
Department of Psychiatry, University of Oxford, The Warneford Hospital, Oxford, United Kingdom
Simon Douglas
Department of Psychiatry, Newcastle University, Newcastle upon Tyne, United Kingdom
Rupert McShane
Oxfordshire and Buckinghamshire Mental Health NHS Trust and University of Oxford, Department of Psychiatry, Fulbrook Centre, Oxford, United Kingdom
Ly-Mee Yu, Edmund Juszczak
Centre for Statistics in Medicine, University of Oxford, Oxford, United Kingdom

Corresponding Author

Email: clive.ballard@kcl.ac.uk

Competing Interests

CB has received honoraria from Novartis, Pfizer, Shire, Lundbeck, Myriad, Janssen, Astra Zeneca, and Servier pharmaceutical companies and research grants from Novartis, Lundbeck, Astra-Zeneca, and Janssen pharmaceuticals. The remaining authors have declared that they have no competing interests.

Author Contributions

CB, RMS, RJ, and EJ designed the experiments/the study. MML, MT, SD, and KK collected data or did experiments for the study. RMS, LY, and EJ analyzed the data. MML, MT, SD, and RJ enrolled patients. CB and EJ wrote the first draft of the paper. SD, RMS, RJ, and EJ contributed to the writing of the paper. MT collected all the data for the Oxfordshire patients over the first two years. SD managed the trial in Newcastle for the majority of its running time, collecting data and also setting up the trial in London. SD also entered data and helped to track down missing data prior to analysis, proof read the manuscript and offered suggestions for changes. RJ contributed to the writing of the grant application and was one of the holders of the grant from the Alzheimer's Research Trust. RJ was also a principal investigator for the study and supervised the collection of the clinical data in the Oxford (UK) patients. KK identified patients, collected data, and wrote the follow-up protocol for the study. LY critically reviewed the manuscript. EJ was the trial statistician and part of the trial management group which met every 2 months. EJ presented regular interim analyses to the Data Monitoring Committee, and co-authored the annual report to the funder. EJ co-wrote the statistical analysis plan and was senior reviewer of the final statistical report.