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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
CHRU de Lille/ Centre d'investigation Clinique
Lille, France
CIC Marseille
Marseille, France
CIC Toulouse
Toulouse, France
Pharmacog battery
* cognitive tests (8 items of the Cantab battery) : * Motor screening * 4 tests for visual memory (Delayed Matching to Sample, Paired Associated Learning, Pattern Recognition Memory, Spatial Recognition Memory) * 1 test for executive functions (Spatial Working Memory) * 2 tests for attention (Reaction Time, Rapid Visual Information Processing) * completed by a modified ADNI battery : ADAScog * imaging * fMRI * PET-FDG * neurophysiological * EEG
Time frame: 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.