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
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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 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 |

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
|
- Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET) [ Time Frame: one year ]
- treatment outcomes (sobriety or relapse) [ Time Frame: one year ]

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Ages Eligible for Study: | 21 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
Contact: Julien Chavant, MA | 2 31 06 54 95 ext +33 | memoire-recherche.caen@inserm.fr |
France | |
Caen University Hospital | Recruiting |
Caen, France, 14000 | |
Principal Investigator: François Vabret, MD |
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 |