Making Evidence-based Decisions Using Alzheimer Therapy (MEDUSA Therapy)
| ISRCTN | ISRCTN55568578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55568578 |
| Secondary identifying numbers | N0038133699 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roger Bullock
Scientific
Scientific
Kingshill Research Centre
Victoria Hospital
Okus Road
Swindon
SN1 4HZ
United Kingdom
| Phone | +44 (0)1793 481182 |
|---|---|
| roger.bullock@kingshill-research.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Making Evidence-based Decisions Using Alzheimer Therapy (MEDUSA Therapy) |
| Study objectives | What evidence is there that altering therapy, after initial treatment starts to fail, will benefit the patient? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cholinesterase inhibitor, rivastigmine, memantine |
| Primary outcome measure | 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 study start date | 30/09/2003 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 75 |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 30/09/2003 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Victoria Hospital
Swindon
SN1 4HZ
United Kingdom
SN1 4HZ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
18/04/2016: No publications found, verifying study status with principal investigator
