Contact information
Type
Scientific
Primary contact
Dr Roger Bullock
ORCID ID
Contact details
Kingshill Research Centre
Victoria Hospital
Okus Road
Swindon
SN1 4HZ
United Kingdom
+44 (0)1793 481182
roger.bullock@kingshill-research.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0038133699
Study information
Scientific title
Making Evidence-based Decisions Using Alzheimer Therapy (MEDUSA Therapy)
Acronym
Study hypothesis
What evidence is there that altering therapy, after initial treatment starts to fail, will benefit the patient?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Alzheimer's disease
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Cholinesterase inhibitor, rivastigmine, memantine
Primary outcome measures
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)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/09/2003
Overall trial end date
01/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
75 participants (i.e. 15 in each arm of the trial) with diagnosis of Alzheimer's disease (AD) and aged between 55 and 95
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
75
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
30/09/2003
Recruitment end date
01/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Victoria Hospital
Swindon
SN1 4HZ
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary