Study on Risk Factors for Prediction of Conversion to Dementia in Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Rate of conversion to dementia
研究概览
简要总结
Mild cognitive impairment (MCI) is believed to be the early stage of dementia. The investigators assume that some psychological and imaging risks may predict the conversion. In the current longitudinal study, psychological and imaging data of people with MCI will be obtained at baseline, and will be followed at 26 weeks and 52 weeks. The predictors will be found in comparison with controls.
详细描述
MCI increases the risk of later developing dementia. About 10-15% of the amnestic form of mild cognitive impairment will progress to Alzheimer's disease in one year. But some people with MCI never get worse. Others with MCI later have test results that return to normal for their age and education.
To develop a new drug for the prevention of dementia(dementia due to Alzheimer's disease or vascular dementia), investigators need a sensitive and specific tool for recognizing patients who will converse to dementia. The investigators want to establish an operational diagnostic criteria instead of a descriptive criteria for mild cognitive impairment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complaint about cognitive decline compared to previous performance
- •objective cognitive impairment in one or more cognitive domains for age
- •preservation of independence in functional abilities
- •Mini-Mental State Examination(MMSE) scores between 24 and 30
- •a Clinical Dementia Rating(CDR) score of 0.5
排除标准
- •patient with any following disease: Parkinson's disease, multiple system atrophy, normal pressure hydrocephalus, progressive supranuclear palsy, subarachnoid hemorrhage, brain neoplasms, Huntington disease, epilepsy
- •depression(HAMD >7) or psychosis
- •uncontrolled severe medical conditions(i.e., acute heart failure, renal insufficiency)
- •current treatment with benzodiazepines, antidepressants, antipsychotics, or other medications with significant psychotropic or central cholinergic effects
- •abnormal thyroid, low vitamin B12 level or low folic acid level
- •patient with visual and auditory disorders can't cooperate with neuropsychological assessment
- •patient can't cooperate with following up
- •informed consent is not obtained
结局指标
主要结局
Rate of conversion to dementia
时间窗: At baseline, 26 weeks, and 52 weeks.
次要结局
- Mini-Mental State Examination(At baseline, 26 weeks, and 52 weeks)
- Trail Making Test(TMT)(At baseline, 26 weeks, and 52 weeks)
- Immediate and delayed story recall(At baseline, 26 weeks, and 52 weeks)
- Clock Drawing Test(CDT)(At baseline, 26 weeks, and 52 weeks)
- Boston Naming Test(At baseline, 26 weeks, and 52 weeks)
- Verbal Category Fluency Test(animals)(At baseline, 26 weeks, and 52 weeks)
- Hopkins Verbal Learning Test(HVLT)(At baseline, 26 weeks, and 52 weeks)
研究者
Jinzhou Tian
Professor
Dongzhimen Hospital, Beijing