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| [ Print-friendly version ] |
| An evaluation of potential therapies to inhibit cerebral emboli in dementia |
| ISRCTN | ISRCTN43384456 |
| ClinicalTrials.gov identifier | |
| Public title | An evaluation of potential therapies to inhibit cerebral emboli in dementia |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | Protocol version 1, EudraCT number: 2005-004283-23 |
| 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 one 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 6 March 2006) |
| Study design | Randomised controlled clinical trial of atorvastatin/clopidogrel/no treatment over one month with crossover in 45 patients with Alzheimers dementia (AD) and 45 with vascular dementia (VaD). |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Dementia, Alzheimer's disease and Vascular Dementia |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 90 (45 patients with AD and 45 with VaD) |
| Interventions |
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 one month, and there is a washout period of one 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. |
| Primary outcome measure(s) | The number of SCE counted during two separate 1-hour periods of monitoring by TCD (at baseline and following each therapy). |
| Secondary outcome measure(s) |
1. Any change in the inflammatory markers to Interleukin-6 or C-Reactive Protein as a result of one month therapy with the trial medications
2. Any change in the measures of cognitive function as a result of one month of therapy using the trial medications |
| Sources of funding | Alzheimer's Society (UK) (grant ref: 87 [30 January 2007]) |
| Trial website | |
| Publications | |
| Contact name | Prof Chrales McCollum |
| Address |
Academic Surgery Unit
2nd Floor, Education and Research Centre University Hospital of South Manchester Southmoor Road |
| City/town | Manchester |
| Zip/Postcode | M23 9LT |
| Country | United Kingdom |
| Tel | +44 (0)161 291 5853 |
| Fax | +44 (0)161 291 5854 |
| cnmcc@manchester.ac.uk | |
| Sponsor | University Hospital of South Manchester (UK) |
| Address |
c/o Dr Andrew Maines
Research and Development Directorate Ground Floor Education and Research Centre University Hospital of South Manchester Southmoor Road |
| City/town | Manchester |
| Zip/Postcode | M23 9LT |
| Country | United Kingdom |
| Tel | +44 (0)161 291 5775 |
| Fax | +44 (0)161 291 5771 |
| andrew.maines@manchester.ac.uk | |
| Sponsor website: | http://www.researchdirectorate.org.uk/ |
| Date applied | 05/06/2007 |
| Last edited | 06/07/2007 |
| Date ISRCTN assigned | 06/07/2007 |
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