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临床试验/NCT01455207
NCT01455207Unknown不适用

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

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
220
试验地点
1
主要终点
Evidence of brain dysfunctioning measured by neuropsychological testing and brain examination(MRI and PET)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

alcoholic patients

Other

干预措施: Neuropsychological testing (Behavioral)

alcoholic patients

Other

干预措施: blood draw (Biological)

alcoholic patients

Other

干预措施: genetic testing (Genetic)

alcoholic patients

Other

干预措施: Brain imaging examination (Other)

korsakoff patients

Other

干预措施: Neuropsychological testing (Behavioral)

korsakoff patients

Other

干预措施: blood draw (Biological)

korsakoff patients

Other

干预措施: genetic testing (Genetic)

korsakoff patients

Other

干预措施: Brain imaging examination (Other)

healthy controls

Other

干预措施: Neuropsychological testing (Behavioral)

healthy controls

Other

干预措施: blood draw (Biological)

healthy controls

Other

干预措施: genetic testing (Genetic)

healthy controls

Other

干预措施: Brain imaging examination (Other)

结局指标

主要结局

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

时间窗: one year

次要结局

  • treatment outcomes (sobriety or relapse)(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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