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:
University Hospital, Caen
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
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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:
MedlinePlus related topics:
Alcoholism and Alcohol Abuse
Genetic and Rare Diseases Information Center resources:
Beriberi
Neurotoxicity Syndromes
Wernicke-Korsakoff Syndrome
U.S. FDA Resources
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
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:
|
Alcohol Amnestic Disorder Alcoholism Korsakoff Syndrome Wernicke Encephalopathy Alcohol-Induced Disorders Alcohol-Induced Disorders, Nervous System Alcohol-Related Disorders Amnesia Avitaminosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Chemically-Induced Disorders Deficiency Diseases Delirium, Dementia, Amnestic, Cognitive Disorders |
Malnutrition Memory Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neurotoxicity Syndromes Nutrition Disorders Poisoning Signs and Symptoms Substance-Related Disorders Thiamine Deficiency Vitamin B Deficiency |
ClinicalTrials.gov processed this record on February 25, 2015