From Uncomplicated Alcoholism to Korsakoff's Syndrome

NCT ID: NCT01455207

Last Updated: 2014-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholism Alcohol Amnestic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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alcoholic patients

Group Type OTHER

Neuropsychological testing

Intervention Type BEHAVIORAL

assessment of memory, executive functions and ataxia

blood draw

Intervention Type BIOLOGICAL

hepatic markers, red blood markers and vitamin markers

genetic testing

Intervention Type GENETIC

genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)

Brain imaging examination

Intervention Type OTHER

MRI, DTI and PET examinations

korsakoff patients

Group Type OTHER

Neuropsychological testing

Intervention Type BEHAVIORAL

assessment of memory, executive functions and ataxia

blood draw

Intervention Type BIOLOGICAL

hepatic markers, red blood markers and vitamin markers

genetic testing

Intervention Type GENETIC

genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)

Brain imaging examination

Intervention Type OTHER

MRI, DTI and PET examinations

healthy controls

Group Type OTHER

Neuropsychological testing

Intervention Type BEHAVIORAL

assessment of memory, executive functions and ataxia

blood draw

Intervention Type BIOLOGICAL

hepatic markers, red blood markers and vitamin markers

genetic testing

Intervention Type GENETIC

genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)

Brain imaging examination

Intervention Type OTHER

MRI, DTI and PET examinations

Interventions

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Neuropsychological testing

assessment of memory, executive functions and ataxia

Intervention Type BEHAVIORAL

blood draw

hepatic markers, red blood markers and vitamin markers

Intervention Type BIOLOGICAL

genetic testing

genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)

Intervention Type GENETIC

Brain imaging examination

MRI, DTI and PET examinations

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

National Research Agency, France

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caen University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Julien Chavant, MA

Role: CONTACT

2 31 06 54 95 ext. +33

Other Identifiers

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11-050

Identifier Type: -

Identifier Source: secondary_id

2011-A00495-36

Identifier Type: -

Identifier Source: org_study_id

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