Hippocampus Study: Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers

Phase 4

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo Comparator; Drug: Experimental 1

• Registration Number: NCT00403520
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to demonstrate that donepezil slows the progression of Alzheimer's disease (AD) using magnetic resonance imaging (MRI) of the brain to measure the volume of the hippocampus in patients with pre-dementia Alzheimer's disease.

Detailed Description

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-21
• Study First Submitted QC: 2006-11-21
• Study First Posted: 2006-11-23
• Primary Completion: 2008-03
• Study Completion: 2010-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Comparator	-
Experimental 1	Experimental 1	-

Primary Outcome Measures

Name	Time	Method
Evolution of the volume of the Hippocampi, measured by magnetic resonance imaging (MRI), between D0 and final visit (12 months ).	( Day 0 to 12 months or in case of premature withdrawal after 6 months period

Secondary Outcome Measures

Name	Time	Method
Evolution of the neuropsychological scores between Day 0 and final visit.	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.

Trial Locations

Locations (1)

CHU Gui de Chauliac; 🇫🇷 Montpellier cedex, France