- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455207
From Uncomplicated Alcoholism to Korsakoff's Syndrome (ALCOBRAIN)
April 8, 2014 updated by: University Hospital, Caen
From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julien Chavant, MA
- Phone Number: +33 2 31 06 54 95
- Email: memoire-recherche.caen@inserm.fr
Study Locations
-
-
-
Caen, France, 14000
- Recruiting
- CAEN University Hospital
-
Principal Investigator:
- François Vabret, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: healthy controls
|
assessment of memory, executive functions and ataxia
hepatic markers, red blood markers and vitamin markers
genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
MRI, DTI and PET examinations
|
Other: alcoholic patients
|
assessment of memory, executive functions and ataxia
hepatic markers, red blood markers and vitamin markers
genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
MRI, DTI and PET examinations
|
Other: korsakoff patients
|
assessment of memory, executive functions and ataxia
hepatic markers, red blood markers and vitamin markers
genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
MRI, DTI and PET examinations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
treatment outcomes (sobriety or relapse)
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
January 1, 2015
Study Completion (Anticipated)
January 1, 2015
Study Registration Dates
First Submitted
October 18, 2011
First Submitted That Met QC Criteria
October 18, 2011
First Posted (Estimate)
October 19, 2011
Study Record Updates
Last Update Posted (Estimate)
April 9, 2014
Last Update Submitted That Met QC Criteria
April 8, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Alcohol-Related Disorders
- Substance-Related Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Brain Diseases, Metabolic
- Vitamin B Deficiency
- Poisoning
- Alcohol-Induced Disorders
- Neurotoxicity Syndromes
- Memory Disorders
- Thiamine Deficiency
- Alcohol-Induced Disorders, Nervous System
- Amnesia
- Alcoholism
- Wernicke Encephalopathy
- Korsakoff Syndrome
- Alcohol Amnestic Disorder
- Alcoholic Korsakoff Syndrome
Other Study ID Numbers
- 2011-A00495-36
- 11-050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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