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