NCT01455207

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

3 years

First QC Date

October 18, 2011

Last Update Submit

April 8, 2014

Conditions

AlcoholismAlcohol Amnestic Disorder

Keywords

Magnetic Resonance ImagingPositon Emission TomographyBehavior

Outcome Measures

Primary Outcomes (1)

  • Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)

    one year

Secondary Outcomes (1)

  • treatment outcomes (sobriety or relapse)

    one year

Study Arms (3)

alcoholic patients

OTHER
Behavioral: Neuropsychological testingBiological: blood drawGenetic: genetic testingOther: Brain imaging examination

korsakoff patients

OTHER
Behavioral: Neuropsychological testingBiological: blood drawGenetic: genetic testingOther: Brain imaging examination

healthy controls

OTHER
Behavioral: Neuropsychological testingBiological: blood drawGenetic: genetic testingOther: Brain imaging examination

Interventions

Neuropsychological testingBEHAVIORAL

assessment of memory, executive functions and ataxia

alcoholic patientshealthy controlskorsakoff patients
blood drawBIOLOGICAL

hepatic markers, red blood markers and vitamin markers

alcoholic patientshealthy controlskorsakoff patients
genetic testingGENETIC

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

alcoholic patientshealthy controlskorsakoff patients
Brain imaging examinationOTHER

MRI, DTI and PET examinations

alcoholic patientshealthy controlskorsakoff patients

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed at least 8 years of education (primary school equivalent)
  • Age-normal corrected hearing and visual acuity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

AlcoholismAlcohol Amnestic DisorderBehavior

Interventions

Neuropsychological TestsBlood Specimen CollectionGenetic Testing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Induced Disorders, Nervous SystemNeurotoxicity SyndromesNervous System DiseasesPoisoningAlcohol-Induced Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Central Study Contacts

Julien Chavant, MA

CONTACT

2 31 06 54 95memoire-recherche.caen@inserm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 19, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

FR(1)