Making Evidence-based Decisions Using Alzheimer Therapy (MEDUSA Therapy)
| ISRCTN | ISRCTN55568578 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55568578 |
| Protocol serial number | N0038133699 |
| Sponsor | Department of Health |
| Funder | Avon and Wiltshire Mental Health Partnership NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cholinesterase inhibitor, rivastigmine, memantine |
| Primary outcome measure(s) |
1. Clinical Global Impression of Change (CGI/C) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Victoria Hospital
Swindon
SN1 4HZ
United Kingdom
SN1 4HZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/04/2016: No publications found, verifying study status with principal investigator
