From Uncomplicated Alcoholism to Korsakoff's Syndrome

Alcoholism Clinical Trial

— ALCOBRAIN  

Official title:

From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01455207
• Other study ID #: 2011-A00495-36
• Secondary ID: 11-050
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: April 8, 2014
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2014
• Source: University Hospital, Caen
• Contact: Julien Chavant, MA
• Phone: 2 31 06 54 95
• Email: memoire-recherche.caen[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Amnestic Disorder
• Alcoholism
• Wernicke Encephalopathy

Intervention

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 (a-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)

Other:
• Brain imaging examination
MRI, DTI and PET examinations

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Caen	Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)		one year	Yes
Secondary	treatment outcomes (sobriety or relapse)		one year	Yes

External Links

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