Assessment of cognitive functions in patients with alcohol-use disorder: Psycho Biochemical Evidences
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- It has been expected that relative to healthy controls, alcohol dependence patients may have poor cognitive scores evaluated by cognitive function tests ie MMSE and MoCA scores (as a primary outcome)
研究概览
简要总结
Introduction
Alcohol consumption is associated with poor cognitive performance particularly executive functions, visuospatial skills, and episodic and working memory, though understanding the association has proved difficult. This variation is due to the methodological limitations in terms of study design ie population selection, age criteria, and a variety of neuropsychological tests measured. Also, little is known about the biological basis of these differences and the prognostic predictors for alcohol consumption. Further, the assessment of how rapidly cognitive impairment is progressing has important clinical implications, since the rate of disease progression may be the most important factor in determining prognosis. A biological marker for rapid cognitive decline would be of importance because at-risk patients can be targeted early for non-pharmacological, medical, and psychosocial interventions to slow deterioration. Thiamine, also known as vitamin B1, exerts neuroprotective effects by maintaining blood-brain barrier integrity, and is particularly, studied as a biological marker for cognitive decline.
LACUNAE
To date, no published literature is available to show the association of alcohol intake and rate of cognitive decline in alcohol-dependent patients among the Indian middle-aged population by evaluating mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), and a specific cognitive biomarker i.e., blood levels of thiamine (vitamin B1).
Aim and Objectives
AIM The present study was designed to understand the effect of harmful alcohol use on neuro-cognitive functions among the middle-aged (36-55years) Indian population.
Objectives
Primary Objective
a. To assess the cognitive functions in middle-aged (36-55years) alcohol-dependent patients:
· by evaluating mini-mental state examination (MMSE) and Montreal cognitive
assessment (MoCA).
· by evaluating the blood levels of cognitive biomarker i.e., plasma Thiamine (vitamin B1).
Secondary Objective
· To compare the above objectives with age and sex-matched healthy controls.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 36.00 Year(s) 至 55.00 Year(s)（—）
入选标准
- •Patients with alcohol dependence will be recruited from the OPD of the Department of Psychiatry, AIIMS, Bathinda.
- •Gender: male.
- •Age group 36 to 55 years.
- •Patients who have undergone alcohol use disorder identification test (AUDIT) criteria for the diagnosis of alcohol dependence.
排除标准
- •Patients with serious medical conditions, seriously sick, non-ambulatory, and non-cooperative patients.
- •Patient of significant liver disease (cirrhosis of liver).
- •History of drug dependence other than nicotine or caffeine.
- •Clinical evidence of Wernicke-Korsakoff syndrome.
- •Significant history of head trauma or brain surgery.
- •Patient with organic brain syndrome, psychotic disorder, major depressive disorder, and bipolar disorder.
结局指标
主要结局
It has been expected that relative to healthy controls, alcohol dependence patients may have poor cognitive scores evaluated by cognitive function tests ie MMSE and MoCA scores (as a primary outcome)
时间窗: all parameters will be recorded at single time point when they will come to Psychiatric OPD
Also reducing the rate of cognitive decline assessed by blood levels of thiamine (as a secondary outcome) among Indian population with alcohol dependence patients.
时间窗: all parameters will be recorded at single time point when they will come to Psychiatric OPD
次要结局
- It has been expected that relative to healthy controls, alcohol dependence patients may have poor cognitive scores evaluated by cognitive function tests ie MMSE and MoCA scores (as a primary outcome)(Also reducing the rate of cognitive decline assessed by blood levels of thiamine (as a secondary outcome) among Indian population with alcohol dependence patients.)