Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,872
- 试验地点
- 1
- 主要终点
- Incidence of cognitive impairment
研究概览
简要总结
The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.
The main questions it aims to answer are:
- incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
- to build a predictive model for the progression of cognitive impairment
详细描述
This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
- •Non-AD patients.
- •The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
- •The participants agree to participate in this study and sign the informed consent form.
排除标准
- •Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
- •Participants who have visual or auditory impairment that hampers the completion of related examination.
- •Situations when magnetic resonance imaging or other examinations are contraindicated.
结局指标
主要结局
Incidence of cognitive impairment
时间窗: 8 years
Number of participants who covert to mild cognitive impairment (MCI) or AD will be recorded to calculate the incidence.
次要结局
- The change of Barthel Index for Activities of Daily Living (ADL)(baseline, 2 year, 4 year, 6 year, 8 year)
- Positron emission tomography (PET)(baseline)
- The change of feces biomarkers(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of blood biomarkers(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of gingival crevicular fluid biomarkers(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of structural MRI(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of magnetic susceptibility(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of Mini-Mental State Examination (MMSE)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of functional MRI(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of urine biomarkers(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of electroencephalogram (EEG)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of speech information(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of perfusion MR imaging(baseline, 2 year, 4 year, 6 year, 8 year)