Shanghai At Risk for Alzheimer's Disease: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,418
- 试验地点
- 1
- 主要终点
- Incidence of cognitive impairment at 5 years
研究概览
简要总结
The goal of this cohort study is to estimate the incidence of AD in the first-degree relatives of patients with AD. The main questions it aims to answer are:
- cognitive changes of subjects at high risk of AD as ageing;
- environmental and behavioral factors affecting AD incidence.
详细描述
This study is a prospective cohort study focusing on the first-degree relatives of patients with Alzheimer's disease (AD). Multiple methods including the neuropsychiatric assessment battery, magnetic resonance imaging (MRI) and fluid biomarkers (blood and urine) are used to estimate the longitudinal changes of the participants at high risk of AD. Besides, a structured questionnaire is designed to investigate how environmental, behavioral and other factors influence the incidence of AD. This study is of great significance in establishing novel guidelines for the prevention and treatment of dementia suitable for Chinese population, and for clinicians to predict the risk of AD in first-degree relatives.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the AD diagnostic criteria of probands meet the 2011 National Institute on Aging - Alzheimer's Association framework, and participants are the first-degree relatives (including parents, children and siblings of the same father and mother) of the proband;
- •not patients with dementia;
- •≥ 50 years, males and females;
- •subjects have lived in Shanghai for more than 1 year and have no plan to move out of Shanghai within 5 years;
- •subjects are able to complete investigation, physical examination, imaging examination and biological specimen collection.
- •Exclusion criteria:
- •Individuals will be excluded if they have:
- •other diseases which could cause cognitive decline, e.g. cerebrovascular diseases, Creutzfeldt-Jakob disease and Parkinsons disease;
- •history of psychological disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
- •uncorrectable visual or auditory impairment that hampers the completion of related examination.
- •pre-menopausal women will also be excluded.
排除标准
- 未提供
结局指标
主要结局
Incidence of cognitive impairment at 5 years
时间窗: 5 years
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
次要结局
- Change From Baseline in Boston naming test (BNT) at 5 years(5 years)
- Change From Baseline in Mini-Mental State Examination (MMSE) at 5 years(5 years)
- Change From Baseline in Montreal cognitive assessment-Basic (MoCA) at 5 years(5 years)
- Change From Baseline in the auditory verbal learning test (AVLT) at 5 years(5 years)
- Change From multi-modal MRI neuroimaging at 5 years(5 years)
- Change From Baseline in trail making test (TMT) at 5 years(5 years)
- Change From Baseline in Geriatric Depression Scale (GDS) at 5 years(5 years)