AlcoholismALCOBRAINNCT01455207
From Uncomplicated Alcoholism to Korsakoff's Syndrome
A study testing Neuropsychological testing, blood draw and genetic testing in people with Alcoholism and Alcohol Amnestic Disorder, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcoholism, Alcohol Amnestic Disorder
- What is being tested?
- Neuropsychological testing, blood draw and genetic testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completed at least 8 years of education (primary school equivalent)
- Age-normal corrected hearing and visual acuity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14000
François Vabret, MD
About this study
Official title: 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.
- Conditions
- Alcoholism, Alcohol Amnestic Disorder
- Being tested
- Neuropsychological testing, blood draw, genetic testing, Brain imaging examination
- Keywords
- Magnetic Resonance Imaging, Positon Emission Tomography, Behavior
- Medical subject headings
- Alcoholism, Alcohol Amnestic Disorder, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingBehavioural
assessment of memory, executive functions and ataxia
blood drawBiological
hepatic markers, red blood markers and vitamin markers
genetic testingGenetic
genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
Brain imaging examinationOther
MRI, DTI and PET examinations
| Study group | Role | What they receive |
|---|---|---|
| alcoholic patients | Other | Not described Receives: Behavioral: Neuropsychological testing; Biological: blood draw; Genetic: genetic testing; Other: Brain imaging examination |
| korsakoff patients | Other | Not described Receives: Behavioral: Neuropsychological testing; Biological: blood draw; Genetic: genetic testing; Other: Brain imaging examination |
| healthy controls | Other | Not described Receives: Behavioral: Neuropsychological testing; Biological: blood draw; Genetic: genetic testing; Other: Brain imaging examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
Measured: one year
Secondary outcomes (1)
treatment outcomes (sobriety or relapse)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455207
- Sponsor's protocol ID
- 2011-A00495-36
- Other IDs
- 11-050
- Acronym
- ALCOBRAIN
- Status last verified
- Apr 2014
- First submitted
- 18 Oct 2011
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Uncomplicated Alcoholism to Korsakoff's Syndrome: Clinical, Genetic, Neuropsychological and Brain Examinations
- ClinicalTrials.gov ID
- NCT01455207
- Acronym / sponsor ID
- ALCOBRAIN / 2011-A00495-36
- Conditions
- Alcoholism, Alcohol Amnestic Disorder
- Keywords
- Magnetic Resonance Imaging, Positon Emission Tomography, Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alcoholic patients | Other | Behavioral: Neuropsychological testing, Biological: blood draw, Genetic: genetic testing, Other: Brain imaging examination |
| korsakoff patients | Other | Behavioral: Neuropsychological testing, Biological: blood draw, Genetic: genetic testing, Other: Brain imaging examination |
| healthy controls | Other | Behavioral: Neuropsychological testing, Biological: blood draw, Genetic: genetic testing, Other: Brain imaging examination |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completed at least 8 years of education (primary school equivalent)
- Age-normal corrected hearing and visual acuity
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingassessment of memory, executive functions and ataxia | Behavioural | alcoholic patients, healthy controls, korsakoff patients |
| blood drawhepatic markers, red blood markers and vitamin markers | Biological | alcoholic patients, healthy controls, korsakoff patients |
| genetic testinggenes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase) | Genetic | alcoholic patients, healthy controls, korsakoff patients |
| Brain imaging examinationMRI, DTI and PET examinations | Other | alcoholic patients, healthy controls, korsakoff patients |
Primary outcome
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)
Time frame: one year
1 secondary outcome
treatment outcomes (sobriety or relapse)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological testing, blood draw and genetic testing in people with Alcoholism and Alcohol Amnestic Disorder, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Chavant, MA (2 31 06 54 95 ext. +33, memoire-recherche.caen@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.