Condition category
Mental and Behavioural Disorders
Date applied
05/06/2007
Date assigned
06/07/2007
Last edited
03/07/2014
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

Prof Charles McCollum

ORCID ID

Contact details

Academic Surgery Unit
2nd Floor
Education and Research Centre
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0) 161 291 5853
cnmcc@manchester.ac.uk

Additional identifiers

EudraCT number

2005-004283-23

ClinicalTrials.gov number

Protocol/serial number

Protocol version 1, EudraCT number: 2005-004283-23

Study information

Scientific title

Acronym

Study hypothesis

The causes of common dementias such as Alzheimer’s Disease (AD) and Vascular Dementia (VAD), which affect 800,000 people in the UK, remain uncertain. We recently found that both AD and VAD are associated with small particles (emboli) in the circulation to the brain and that patients with these emboli suffer a more rapid progression of dementia. Prior to major clinical trials on whether therapy to inhibit emboli may prevent or treat dementia, we need to study possible therapies that may inhibit these emboli. We plan to compare two therapeutic approaches:
1. Platelet inhibition
2. An anti-inflammatory lipid therapy thought to stabilise arterial disease

Patients will be given no new treatments. The number of emboli in the cerebral circulation measured by non-invasive ultrasound, assessment of brain function and markers of inflammation associated with dementia will be measured before and after 1 month of the trial treatment. Any treatment or combination of treatments that inhibit cerebral emboli will then be investigated further in major clinical trials on the treatment of established dementia or the prevention of dementia in ‘at risk’ elderly people.

Ethics approval

South Manchester Research Ethics Committee (ref: 05/Q1403/214), Amendment number 1 (Amendment date 06/03/2006)

Study design

Randomised controlled clinical trial of atorvastatin/clopidogrel/no treatment over 1 month with crossover in 45 patients with Alzheimer's dementia (AD) and 45 with vascular dementia (VaD)

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

Dementia, Alzheimer's disease and Vascular Dementia

Intervention

Patients who are already taking aspirin will continue aspirin therapy. No patient will have therapeutic medication withdrawn.

Those with Spontaneous Cerebral Emboli (SCE) will be randomised, stratified for type of dementia, into one of three counterbalanced treatment orders:
1. Clopidogrel; Atorvastatin; No treatment
2. Atorvastatin; No treatment; Clopidogrel
3. No treatment; Clopidogrel; Atorvastatin

Each treatment will last for 1 month, and there is a washout period of 1 week between each treatment. Transcranial Doppler (TCD) measurement of SCE over two separate 1-hour periods on different days in the same week will be repeated after 4 weeks on each therapy.

Intervention type

Drug

Phase

Not Applicable

Drug names

Atorvastatin, clopidogrel

Primary outcome measures

The number of SCE counted during two separate 1-hour periods of monitoring by TCD (at baseline and following each therapy).

Secondary outcome measures

1. Any change in the inflammatory markers to Interleukin-6 or C-Reactive Protein as a result of 1 month therapy with the trial medications
2. Any change in the measures of cognitive function as a result of 1 month of therapy using the trial medications

Overall trial start date

01/07/2007

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Dementia: patients must fulfil DSM IV criteria for dementia (Diagnostic and Statistic Manual of Mental Disorders - fourth edition)
2. AD: patients must fulfil the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
3. VAD: patients must fulfil the National Institute for Neurological and Communicative Disorders and Stroke -Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINCDS−AIREN) criteria

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

90 (45 patients with AD and 45 with VaD)

Participant exclusion criteria

1. Patients with a Mini-Mental State Examination (MMSE) score of less than 10 and/or severe aphasia (as the study requires considerable co-operation)
2. Current anticoagulant treatment (may reduce spontaneous emboli)
3. Current clopidogrel treatment
4. Current statin treatment
5. Diagnosed as suffering from Atrial Fibrillation (AF)
6. Diagnosed with significant liver disease: a liver function test will be carried out if liver disease is clinically indicated in any participants
7. Diagnosed with active pathological bleeding such as peptic ulcer or intracranial haemorrhage
8. Any surgery scheduled during study involvement
9. Baseline coagulation parameters suggest unsuitability for clopidogrel/atorvastatin treatment

Recruitment start date

01/07/2007

Recruitment end date

30/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Surgery Unit
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

University Hospital of South Manchester (UK)

Sponsor details

c/o Dr Andrew Maines
Research and Development Directorate
Ground Floor
Education and Research Centre
University Hospital of South Manchester
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 (0) 161 291 5775
andrew.maines@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.researchdirectorate.org.uk/

Funders

Funder type

Charity

Funder name

Alzheimer's Society (UK) (grant ref: 87 [30 January 2007])

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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