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Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in Elderly

Information source: Biocodex
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Volunteers Aged Between 65 and 75 Years Old

Intervention: etifoxine (Drug); Lorazepam (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Biocodex

Overall contact:
Pr DEPLANQUE Dominique , MD, PhD

Summary

Evaluation of the effects of etifoxine versus a benzodiazepine (lorazepam) on vigilance and cognitive functions in the elderly.

Clinical Details

Official title: Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly. A Monocentric, Randomized, Cross-over, Double-blind Clinical Study Versus Placebo

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Reaction time (RTI) of Cambridge Neuropsychological Test Automated Batteries (CANTAB)

Detailed description: Evaluation of the effects of etifoxine 100 mg and lorazepam 2 mg, as a single dose intake, on vigilance and cognitive functions in the elderly.

Eligibility

Minimum age: 65 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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).

Locations and Contacts

Pr DEPLANQUE Dominique , MD, PhD

Centre d'Investigation Clinique, CIC 1403 INSERM/CHRU, Lille 59037, France; Recruiting
DEPLANQUE Dominique, MD, PhD, Phone: 0033320445449, Email: dominique.deplanque@chru-lille.fr
DEPLANQUE Dominique, MD, PhD, Principal Investigator
Additional Information

Starting date: December 2013
Last updated: May 20, 2014

Page last updated: August 23, 2015

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