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A randomised, double blind, placebo-controlled clinical trial to compare the progression of cognitive impairment in dementia patients continuing to take, or discontinued from, treatment with neuroleptics
ISRCTN ISRCTN33368770
DOI 10.1186/ISRCTN33368770
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised, double blind, placebo-controlled clinical trial to compare the progression of cognitive impairment in dementia patients continuing to take, or discontinued from, treatment with neuroleptics
Scientific title
Acronym N/A
Serial number at source N0504126576
Study hypothesis The hypothesis that the study is designed to test is that in a randomised study, treatment with neuroleptic agents will be associated with an accelerated rate of cognitive decline in dementia patients.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised, double blind, placebo-controlled clinical trial
Countries of recruitment United Kingdom
Disease/condition/study domain Nervous System Diseases: Dementia
Participants - inclusion criteria 220 patients who will be living in nursing homes, at home with a carer, or in sheltered accommodation who fulfil the NINCDS/ADRDA for probable or possible Alzheimer's Disease and who have been taking neuroleptic medication for a minimum of three months
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/06/2002
Anticipated end date 31/05/2007
Status of trial Completed
Patient information material
Target number of participants 220
Interventions Dementia patients continuing to take, or discontinued from, treatment with neuroleptics.
Primary outcome measure(s) The primary outcome will be cognitive change on the Severe Impairment Battery.
Secondary outcome measure(s) The ADL measures, CAMCOG (including MMSE), FAST and other cognitive assessments will be evaluated as secondary outcomes.
Sources of funding Northumbria Healthcare NHS Trust (UK)
Trial website
Publications 2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18384230
Contact name Prof  CG  Ballard
  Address Institute for Ageing and Health
Newcastle General Hospital
West Road
  City/town Newcastle upon Tyne
  Zip/Postcode NE4 6BE
  Country United Kingdom
Sponsor Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2005
Last edited 11/11/2008
Date ISRCTN assigned 30/09/2005
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