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From Uncomplicated Alcoholism to Korsakoff's Syndrome (ALCOBRAIN)

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ClinicalTrials.gov Identifier: NCT01455207
Recruitment Status : Unknown
Verified April 2014 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : October 19, 2011
Last Update Posted : April 9, 2014
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Alcoholism Alcohol Amnestic Disorder Behavioral: Neuropsychological testing Biological: blood draw Genetic: genetic testing Other: Brain imaging examination Not Applicable

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
Study Start Date : January 2012
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET) [ Time Frame: one year ]

Secondary Outcome Measures :
  1. treatment outcomes (sobriety or relapse) [ Time Frame: one year ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT01455207     History of Changes
Other Study ID Numbers: 2011-A00495-36
11-050
First Posted: October 19, 2011    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

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

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