Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes

18/04/2016: No publications found, verifying study status with principal investigator