NCT00403520

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

Assessment of the Comparative Effect of Donepezil 10mg/d and Placebo on Clinical and Radiological Markers in Patients With Mild Cognitive Disorders

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Experimental 1	Drug: Donepezil Hydrochloride 10 mg orally for 12 months
DRUG	Placebo Comparator	Drug: Placebo Matching placebo orally for 12 months

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-03-01
• Completion: 2010-08-01
• First posted: 2006-11-23
• Last updated: 2014-07-14

Locations

1 site across 1 country: France