Alzheimer's Disease and Vascular Dementia
Conditions
Interventions
Product Name: Clopidogrel
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
South Manchester University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Dementia - patients must fulfill DSM IV criteria for dementia (Diagnostic and Statistic Manual of Mental Disorders 1995) . AD - patients must fulfill the NINCDS-ADRDA criteria (McKhann G et al 1984) . VaD - patients must fulfill the NINCDS-AIREN criteria (Roman G D et al 1993) . Patient must have an identified carer who can manage any trial medication Controls: No evidence of cognitive impairment or any other significant health impairment which might interfere with their participation. American Psychiatric Association. Diagnoswtic and Statistical Manual of Mental Disorders. 1995. Fourth Edition. AMA, Washington DC. McKhann G et al. Clinical Diagnosis of Alzheimer's disease: Report of the NINCSA-ADRDA work Group under the auspices of the Department of Health and Human Services Task Force of Alzheimer's disease. Neurology 1984;34:939-944. Roman GD et al. Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-Airen International Workshop. Neurology 1993;43(February):250-260. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: . Patients with a Mini-Mental State Examination (MMSE) (Folstein et al 1975, Molloy et al 1991) score of <10 and/or severe aphasia (as the study requires considerable co-opoeration) . Current anticoagulant treatment (may reduce spontaneous emboli) . Diagnosed as suffering from AF Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 1975 Nov;12(3):189-98 Molloy DW, Alemayehu E, Roberts R. A standardised Mini-Mental State Examination (MMSE). American Journal of Psychiatry 1991;148 p102-105.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our hypothesis is that treatment may reduce the numbers of particles entering the blood supply to the brain (spontaneous cerebral emboli, or SCE) in patients with demential. Ultimately, we aim to investigate whether inhibiting SCE arrests or delays the progression of memory loss. This proposal is to undertake a pilot clinical trial in patients with dementia to investigate whether SCE are inhibited by a one month course of either: (i) Clopidogrel (a medication similar to aspirin that thins the blood) (ii) atorvastatin (a widely prescribed medication to reduce cholesterol) (iii) no treatment (control) ;Secondary Objective: Although one month is a short time period, we will also be looking for any changes in cognitive function that might be due to the treatments.;Primary end point(s): The primary endpoint will be the change in the number of SCE detected during the 2 hrs of monitoring before and following randomized therapy. | — |
Countries
United Kingdom
Outcome results
None listed