From Uncomplicated Alcoholism to Korsakoff’s Syndrome

Overview

This research project aims to identify factors that contribute to the heterogeneity observed in neuroradiological and neuropsychological signs of chronic alcoholism. The investigators overarching hypothesis is that the heterogeneity of alcoholic consequences on brain structure and metabolism, and cognition is mainly related to individual differences in pattern of alcohol use, gene pool, nutritional status and history of withdrawal symptoms.

Full Title of Study: “From Uncomplicated Alcoholism to Korsakoff’s Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2015

Interventions

  • Behavioral: Neuropsychological testing
    • assessment of memory, executive functions and ataxia
  • Biological: blood draw
    • hepatic markers, red blood markers and vitamin markers
  • Genetic: genetic testing
    • genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
  • Other: Brain imaging examination
    • MRI, DTI and PET examinations

Arms, Groups and Cohorts

  • Other: alcoholic patients
  • Other: korsakoff patients
  • Other: healthy controls

Clinical Trial Outcome Measures

Primary Measures

  • Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
    • Time Frame: one year

Secondary Measures

  • treatment outcomes (sobriety or relapse)
    • Time Frame: one year

Participating in This Clinical Trial

Inclusion Criteria

  • Completed at least 8 years of education (primary school equivalent) – Age-normal corrected hearing and visual acuity Exclusion Criteria:
  • documented loss of consciousness of over 30 minutes, documented compound skull fracture, or clear neurological sequelae of head trauma – history of medical or neurological illness or trauma potentially affecting the CNS, e.g., stroke, multiple sclerosis, epilepsy, psychosurgery, insulin coma. – active tuberculosis or history of or any malignancy requiring chemotherapy – history of schizophrenia or bipolar disorder – metal implantation (e.g., pacemakers) or other factors that preclude MRI scanning for subjects selected for the neuroimaging examination – meet DSM-IV criteria for current (past 3 months) other Substance Abuse – met DSM-IV criteria for other Substance Dependence – Have used other substances more than 5 times in the past month
  • Gender Eligibility: All

    Minimum Age: 21 Years

    Maximum Age: 70 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • University Hospital, Caen
    • Collaborator
      • Institut National de la Santé Et de la Recherche Médicale, France
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Contact(s)
      • Julien Chavant, MA, 2 31 06 54 95, memoire-recherche.caen@inserm.fr

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