Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cognitive improvement
研究概览
简要总结
Alcohol is one of most common harmful substance, and alcohol intake brings great burden on health worldwide. Excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment. Although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies, there is no relevant clinical trial about their efficacy and safety on patients. Since nerve growth factor and one of the antioxidative medication, edaravone, have been used in some neural diseases in clinical trials, we tend to evaluate the efficacy and safety of nerve growth factor, or edaravone on alcohol-induced brain injuries. The study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly: (1) regular treatment (combination of vitamin B1, B6, C, E and mecobalamine) with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months; (2) regular treatment (RT) with edaravone for 2 weeks and subsequently RT for 6 months; (3) RT alone for 6 months. The patients will be followed up for 6 months. Cognitive functions, recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as alcohol dependence according to DSM-IV criteria
- •MRI-proved demyelinating lesions or atrophy in the brain of the patient
- •No definite history of neurological diseases and psychological problems
- •Volunteer to participate the study, cooperate to be followed up
排除标准
- •Acute withdrawal state and CIWA score > 9
- •With other neurological diseases and psychological problems
- •With ever brain trauma and damage
- •With other psychological medications or other substance dependence
研究组 & 干预措施
Regular treatment (RT)
Combination of vitamin B1, B6, C, E and mecobalamine
干预措施: Combination of vitamin B1, B6, C, E and mecobalamine (Drug)
RT with NGF
Nerve growth factor adding to regular treatment
干预措施: Nerve Growth Factor (Drug)
RT with NGF
Nerve growth factor adding to regular treatment
干预措施: Combination of vitamin B1, B6, C, E and mecobalamine (Drug)
RT with EDV
Edaravone adding to regular treatment
干预措施: Edaravone (Drug)
RT with EDV
Edaravone adding to regular treatment
干预措施: Combination of vitamin B1, B6, C, E and mecobalamine (Drug)
结局指标
主要结局
Cognitive improvement
时间窗: 6 months
Executive function by digit symbol substitute test (DSST) ranging from 0 to 90. Higher score indicates better executive function.
Cognitive assessment
时间窗: 6 months
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
次要结局
- Craving for alcohol(2 weeks, 2 months, 3 months, 6 months)
- Psychological assessment - Depression(2 weeks, 2 months, 3 months, 6 months)
- The rate of relapse of alcohol dependence after discharge from hospital(2 months)
- Duration of abstinence(6 months)
- Alcohol intake(2 weeks, 2 months, 3 months, 6 months)
- Psychological assessment - Anxiety(2 weeks, 2 months, 3 months, 6 months)
- Psychological assessment - Sleep(2 weeks, 2 months, 3 months, 6 months)
研究者
Ying Peng
Professor, Director of Department of Neurology
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
