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ISRCTN
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ISRCTN55568578
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ClinicalTrials.gov identifier
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Public title
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Making Evidence-based Decisions Using Alzheimer Therapy (MEDUSA Therapy)
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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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N0038133699
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Study hypothesis
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What evidence is there that altering therapy, after initial treatment starts to fail, will benefit the patient?
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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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Alzheimer's disease
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Participants - inclusion criteria
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75 participants, (i.e. 15 in each arm of the trial) with diagnosis of Alzheimer's disease (AD) and aged between 55 and 95.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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30/09/2003
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Anticipated end date
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01/12/2004
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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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75
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Interventions
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Randomised controlled trial (RCT):
1. Cholinesterase inhibitor (ChEi) as usual
2. Increased dose of ChEi
3. Rivastigmine
4. Memantine
5. ChEi as usual, plus memantine
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Primary outcome measure(s)
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1. Clinical Global Impression of Change (CGI/C)
2. Mini-Mental State Examination (MMSE)
3. BAYER-Activities of Daily Living (ADL)
4. Neuropsychiatric inventory questionnaire (NPI-Q)
5. Global Assessment Scale (GAS)
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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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Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Roger
Bullock
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Address
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Kingshill Research Centre
Victoria Hospital
Okus Road
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City/town
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Swindon
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Zip/Postcode
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SN1 4HZ
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Country
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United Kingdom
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Tel
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+44 (0)1793 481182
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Fax
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+44 (0)1793 437521
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Email
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roger.bullock@kingshill-research.org
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Sponsor
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Record Provided by the NHSTCT Register - 2004 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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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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30/09/2004
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Last edited
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28/01/2010
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Date ISRCTN assigned
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30/09/2004
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