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Effect of a 15-day Donepezil Treatment on Biomarkers of AD in Healthy Volunteers
The early assessment of new drugs for Alzheimer's disease remains difficult because of the lack of predictive end-point. The use of a battery including different parameters could improve this early development of new drugs. Nevertheless, the interest of such a battery should previously be validated with the yet marketed AD drugs
The aim of the present study is to test the effect of a 15-day treatment with donepezil on a mixed battery associating cognitive assessment, imaging and neurophysiological tests in healthy volunteers. This multicenter, randomized, placebo-controlled, cross-over study is double-blind controlled and is conducted in 3 centers located in France (Lille, Marseille and Toulouse). 18-30 years old, healthy volunteers, without any neurological or psychiatric impairment, will complete 2 test sessions in a randomized order: one with a 15-day treatment with donepezil, the other with placebo, and will be submitted to a mixed battery during the 14th and 15th day of the treatment. The primary outcome of the study will be based on cognitive assessment, imaging parameters and neurophysiological parameters.
Age
18 - 30 years
Sex
MALE
Healthy Volunteers
Yes
CHRU de Lille/ Centre d'investigation Clinique
Lille, France
CIC Marseille
Marseille, France
CIC Toulouse
Toulouse, France
Start Date
December 1, 2011
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2013
Last Updated
April 9, 2015
30
ACTUAL participants
Donepezil .
DRUG
Placebo
DRUG
Lead Sponsor
University Hospital, Lille
Collaborators
NCT04123314
NCT07178210
Data Source & Attribution
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