From Uncomplicated Alcoholism to Korsakoff's Syndrome (ALCOBRAIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Caen
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
National Research Agency, France
Information provided by (Responsible Party):
University Hospital, Caen
ClinicalTrials.gov Identifier:
NCT01455207
First received: October 18, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Alcoholism
Alcohol Amnestic Disorder
Behavioral: Neuropsychological testing
Biological: blood draw
Genetic: genetic testing
Other: Brain imaging examination

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations

Resource links provided by NLM:


Further study details as provided by University Hospital, Caen:

Primary Outcome Measures:
  • Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • treatment outcomes (sobriety or relapse) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
alcoholic patients 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
korsakoff patients 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
healthy controls 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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455207

Contacts
Contact: Julien Chavant, MA 2 31 06 54 95 ext +33 memoire-recherche.caen@inserm.fr

Locations
France
Caen University Hospital Recruiting
Caen, France, 14000
Principal Investigator: François Vabret, MD         
Sponsors and Collaborators
University Hospital, Caen
Institut National de la Santé Et de la Recherche Médicale, France
National Research Agency, France
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01455207     History of Changes
Other Study ID Numbers: 2011-A00495-36, 11-050
Study First Received: October 18, 2011
Last Updated: April 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Caen:
Magnetic Resonance Imaging
Positon Emission Tomography
Behavior

Additional relevant MeSH terms:
Amnesia
Alcohol Amnestic Disorder
Alcoholism
Korsakoff Syndrome
Wernicke Encephalopathy
Alcohol-Induced Disorders, Nervous System
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Metabolic Diseases
Thiamine Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 21, 2014