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Sponsored by: |
Eisai GmbH |
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00403520 |
The development of a new automated method of measurement of the volume of the hippocampus allows confirming these results in patients presenting with pre-dementia AD, treated with donepezil in order to verify if this product is capable of stopping the speed of the atrophy of the hippocampus in patients and more specifically in those who will evolve to AD, compared to a placebo. This method is a semi automatic segmentation of the hippocampus from MRI, made by competitive region growing.
It was developed at the cognitive neurosciences and MRI laboratory in Pitié-Salpêtrière hospital. This method was validated on healthy subjects (M. Chupin and al., 2002, 2003) and Alzheimer's disease patients (M. Chupin and al., 2004) by comparison with manual segmentation.
Neuropsychological tests will be realized in order to supervise the clinical evolution of the patients and to correlate these results to the progression of the atrophy of the hippocampus.
Condition | Intervention | Phase |
Alzheimer's Disease |
Drug: Donepezil hydrochloride |
Phase IV |
Genetics Home Reference related topics: | Alzheimer disease |
MedlinePlus related topics: | Alzheimer's Disease |
ChemIDplus related topics: | Donepezil E 2020 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders |
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (Baseline Visit ("V0")):
Exclusion Criteria (Baseline Visit ("V0")):
Patients with a contraindication to MRI:
Patients with an evolutive psychiatric pathology and/or unstable according to DSM-IV, particularly:
Patients with neurological disorders:
Inclusion criteria (Visit 1):
Exclusion criteria (Visit 1):
Patients with an evolutive psychiatric pathology and/or unstable according to DSM-IV, particularly:
Patients with neurological disorders :
Study ID Numbers: | E2020-E033-415 |
First Received: | November 21, 2006 |
Last Updated: | October 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00403520 |
Health Authority: | France: French Medicines Agency |
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