Volunteers Aged Between 65 and 75 Years Old | Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in Elderly
Volunteers Aged Between 65 and 75 Years Old research study
What is the primary objective of this study?
Evaluation of the effects of etifoxine versus a benzodiazepine (lorazepam) on vigilance and cognitive functions in the elderly.
Who is eligible to participate?
Inclusion Criteria: - Man or woman aged from 65 to 75 years - Right-handed subject (Edinburgh Handedness inventory) - Subject having signed the consent form - Subject having agreed to be listed on the French National Healthy Volunteers database - Subject affiliated or beneficiary to French social insurance Exclusion Criteria: - Subject presenting a neurological or psychiatric disease notably cognitive, progressing - Anxious subject (Hamilton score > 7 and/or Spielberger score > 51 for a man or > 61 for a woman) - Left-handed subject (Edinburgh Handedness inventory) - Subject presenting a not corrected visual disease or a motor function disease that could interfere with tests realization - Smoker - Subject taking one or more psychotrops or apparented products - Subject having taken, during the previous month, one or more drugs that could interfere with study drugs metabolism - Subject drinking too much coffee or tea (> 4 cups per day) or alcohol (>½ liter of wine or equivalent per day) - Subject presenting contra-indication to one of the drugs used in the study - Subject with past history of intolerance to drugs used in the study - Subject not capable to use the CANTAB cognitive evaluation system - Subject which may not be able to participate to the whole study - Subject under tutelage or guardianship - Subject not able to well-understand French and so to understand cognitive tests - Subject not capable to swallow capsules - Subject participating to another study or in exclusion period (3 months after a previous trial).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Volunteers Aged Between 65 and 75 Years Old
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
etifoxine (Anxiolytic)etifoxine, 100 mg, a single oral intake
lorazepam (Anxiolytic)lorazepam, 2 mg, a single oral intake
Placebo2 capsules of Placebo, a single oral intake
Start Date: December 2013
Phase: Phase 3
Primary Outcome: Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)
Study sponsors, principal investigator, and references
Lead Sponsor: Biocodex