E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Alzheimer's Disease and Vascular Dementia |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Investigation of the effects of emboli reduction on combined cerebral oximetry and cerebral blood flow measurments in the common dementias. V1 15/Mar/2009
Objectives:
As a pilot study we wish to study the effects of emboli reduction on combined cerebral oximetry and cerebral blood flow measurments in patients randomised to receiving the trial medications.
For this purpose, we wish to also recruit a group of 10 age and sex matched control subjects to study baseline cerebral oxygen saturation readings during the performance of a computerised battery of tests (CANTAB)
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E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject taking part in the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |