How legislation on decisional capacity can negatively affect the feasibility of clinical trials in patients with dementia.

Drugs & Aging
Francesca GaleottiAdCare Study Group

Abstract

Antipsychotic drugs are widely used to treat behavioural and psychological disturbances associated with Alzheimer's disease (AD), although only modest evidence from randomized controlled trials supports their efficacy, and increasing evidence from post-marketing surveillance shows serious adverse events associated with their use, including increased mortality. The AdCare study, a non-profit, randomized, placebo-controlled, double-blind, multicentre, pragmatic trial coordinated by the Italian National Institute of Health, aimed to evaluate the long-term safety and efficacy profiles of three atypical antipsychotic drugs (risperidone, olanzapine and quetiapine) and one conventional antipsychotic drug (haloperidol) in treating psychosis, aggression and agitation in outpatients with AD. The study was planned to be carried out in 19 clinical centres and to enrol 1000 outpatients. According to Italian law, in the case where a patient is considered unable to give informed consent, a legal representative designated by the court has to provide it. Because of difficulties in the informed consent procedure, the study had to be prematurely interrupted. From February 2009 to April 2010, 83 patients gave informed consent to participate in the...Continue Reading

References

Oct 1, 1986·Journal of the American Geriatrics Society·J Cohen-Mansfield, N Billig
Nov 18, 1998·The Journal of Clinical Psychiatry·K L LanctôtC A Naranjo
May 4, 2004·The American Journal of Psychiatry·Scott Y H KimJason T Olin
Jan 28, 2005·Neuropsychology Review·Karen Sullivan
Feb 18, 2006·Nature Reviews. Drug Discovery·Jeffrey L Cummings, Kate Zhong
Mar 1, 2006·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Lon S SchneiderPhilip S Insel
Aug 1, 2006·The American Journal of Psychiatry·Laura B DunnElyn R Saks
Sep 8, 2006·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Gudrun SchneiderGereon Heuft
Oct 13, 2006·The New England Journal of Medicine·Lon S SchneiderUNKNOWN CATIE-AD Study Group
Nov 6, 2007·The New England Journal of Medicine·Paul S Appelbaum
Jul 22, 2008·Lancet·James Warner, Erum Nomani
Aug 30, 2008·CMAJ : Canadian Medical Association Journal = Journal De L'Association Medicale Canadienne·Elmira ValiyevaGeoffrey M Anderson
Oct 18, 2008·BMJ : British Medical Journal·Paul M StewartMorris J Brown
Nov 10, 2009·International Clinical Psychopharmacology·Gianluca TrifiròFabio Samani
Nov 18, 2009·PLoS Medicine·Alex D McMahonGordon T McInnes
Jan 9, 2010·European Journal of Clinical Investigation·UNKNOWN Italian Medicines Agency (AIFA) Research & Development Working Group
Jan 13, 2010·Archives of Internal Medicine·E Ray DorseyG Caleb Alexander
Feb 5, 2010·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Brian DraperHenry Brodaty
May 26, 2010·Bioethics·Alexander FriedmanDavid Wendler

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Citations

Sep 18, 2012·Neurología : publicación oficial de la Sociedad Española de Neurología·E L Gómez-DuránJ Arimany-Manso
Nov 22, 2016·Aging & Mental Health·R M DröesUNKNOWN INTERDEM sOcial Health Taskforce
Oct 9, 2018·Alzheimer's & Dementia : the Journal of the Alzheimer's Association·Adrian ThorogoodUNKNOWN Global Alliance for Genomics and Health, Ageing and Dementia Task Team

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