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ISRCTN
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ISRCTN62185868
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DOI
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10.1186/ISRCTN62185868
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ClinicalTrials.gov identifier
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NCT00142324
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EudraCT number
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Public title
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A Randomised Placebo Controlled Trial of a Cholinesterase Inhibitor in the Management of Agitation in Dementia that is Unresponsive to a Psychological Intervention
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Scientific title
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Acronym
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CALM-AD Trial
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Serial number at source
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G0100070
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Study hypothesis
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To determine whether risperidone or donepezil are significantly better than placebo respectively in the management of agitation in AD that has not responded to, or is inappropriate for a standardized brief psychosocial treatment (BPST).
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Lay summary
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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 controlled 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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Neurosciences, psychiatry
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Participants - inclusion criteria
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1. Probable or possible Alzheimer's disease (AD)
2. Clinically significant agitation
3. Age >39 years
4. Resident in care facility or community resident with carer
5. Not receiving treatment with neuroleptics or chlornesterase inhibitors
6. Carer with capacity to consent.
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Participants - exclusion criteria
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1. Known sensitivity to donepezil or resperidone
2. Severe, unstable or uncontrolled medical conditions apparent from history, physical examination or investigations
3. Current evidence of delirium
4. Patient meets criteria for Probable Dementia with Lewy Bodies (McKeith et al, 1996)
5. Low probability of treatment compliance
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Anticipated start date
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01/11/2003
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Anticipated end date
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30/04/2006
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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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285
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Interventions
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Randomised to receive:
1. Risperidone 0.5-1.0 mg
2. Donepezil 5-10mg
3. Placebo
For 12 weeks.
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Primary outcome measure(s)
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A reduction in score on the Cohen Mansfield Agitation Inventory.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17914039
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Contact name
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Dr
Robert
Howard
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Address
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Division of Psychological Medicine
Institute of Psychiatry
De Crespigny Park
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City/town
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London
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Zip/Postcode
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SE5 8AF
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Country
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United Kingdom
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Email
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Sponsor
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King's College London (UK)
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Address
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Strand
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City/town
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London
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Zip/Postcode
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WC2R 2LS
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Country
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United Kingdom
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Tel
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+44 (0)20 7836 5454
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Email
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ceu@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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21/09/2000
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Last edited
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07/09/2009
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Date ISRCTN assigned
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21/09/2000
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