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From Uncomplicated Alcoholism to Korsakoff's Syndrome (ALCOBRAIN)

Primary Purpose

Alcoholism, Alcohol Amnestic Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological testing
blood draw
genetic testing
Brain imaging examination
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Magnetic Resonance Imaging, Positon Emission Tomography, Behavior

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

alcoholic patients

korsakoff patients

healthy controls

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

treatment outcomes (sobriety or relapse)

Full Information

First Posted
October 18, 2011
Last Updated
April 8, 2014
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
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1. Study Identification

Unique Protocol Identification Number
NCT01455207
Brief Title
From Uncomplicated Alcoholism to Korsakoff's Syndrome
Acronym
ALCOBRAIN
Official Title
From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Alcohol Amnestic Disorder
Keywords
Magnetic Resonance Imaging, Positon Emission Tomography, Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alcoholic patients
Arm Type
Other
Arm Title
korsakoff patients
Arm Type
Other
Arm Title
healthy controls
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing
Intervention Description
assessment of memory, executive functions and ataxia
Intervention Type
Biological
Intervention Name(s)
blood draw
Intervention Description
hepatic markers, red blood markers and vitamin markers
Intervention Type
Genetic
Intervention Name(s)
genetic testing
Intervention Description
genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
Intervention Type
Other
Intervention Name(s)
Brain imaging examination
Intervention Description
MRI, DTI and PET examinations
Primary Outcome Measure Information:
Title
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
Time Frame
one year
Secondary Outcome Measure Information:
Title
treatment outcomes (sobriety or relapse)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien Chavant, MA
Phone
2 31 06 54 95
Ext
+33
Email
memoire-recherche.caen@inserm.fr
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Vabret, MD

12. IPD Sharing Statement

Learn more about this trial

From Uncomplicated Alcoholism to Korsakoff's Syndrome

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