Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers
|Alzheimer's Disease||Drug: Experimental 1 Drug: Placebo Comparator||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders|
- Evolution of the volume of the Hippocampi, measured by magnetic resonance imaging (MRI), between D0 and final visit (12 months ). [ Time Frame: ( Day 0 to 12 months or in case of premature withdrawal after 6 months period ]
- Evolution of the neuropsychological scores between Day 0 and final visit. [ Time Frame: Day 0 to 12 during treatment and at 18 months follow up ]Outcome Measure Description: Patients will perform neuropsychological and independence tests including (16 items free recall/cued recall test using the Grober-Buschke method, Mini-Mental State Examination (MMSE), Clinical Dementia Rating (CDR) sum of the boxes and Instrumental Activities of Daily Living (IADL), and will be evaluated using the Hamilton Scale.
|Study Start Date:||November 2006|
|Study Completion Date:||August 2010|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
|Experimental: Experimental 1||
Drug: Experimental 1
Drug: Donepezil Hydrochloride 10 mg orally for 12 months
|Placebo Comparator: Placebo Comparator||
Drug: Placebo Comparator
Drug: Placebo Matching placebo orally for 12 months
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 Alzheimer's Disease (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 and Alzheimer's disease patients 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403520
|CHU Gui de Chauliac|
|Montpellier cedex, France|
|Study Director:||Isabelle Tonelli||Eisai France|