An evaluation of potential therapies to inhibit cerebral emboli in dementia

Not Applicable

Completed

• Conditions: Dementia, Alzheimer's disease and Vascular Dementia; Mental and Behavioural Disorders; Organic, including symptomatic, mental disorders

• Registration Number: ISRCTN43384456
• Lead Sponsor: niversity Hospital of South Manchester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-06
• Study Completion: 2009-06-30
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 33

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Any change in the measures of cognitive function as a result of 1 month of therapy using the trial medications<br>