Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The change of incidence of cognitive impairment
研究概览
简要总结
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood, APOE genotype, brain MRI, speech information, AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET were collected and analyzed. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of cognitive impairment.
详细描述
This study is a prospective observational study, which involves a cohort of 2000 all-sex and all-ethnic people aged 60 years and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburban area), Shanghai. Demographic information, neuropsychiatric scale, peripheral blood serum Aβ40, Aβ42, p-tau 181, 217, urine proteomic analysis, APOE genotype analysis, brain MRI, and speech information were collected and analyzed. After initial screening 20% of patients with clinically confirmed MCI and AD were randomly selected for AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, and cholinergic receptor probe (ASEM) PET. Follow-up visits were performed twice a year for 4 visits, and neuropsychiatric scales and biological samples were collected at each follow-up visit to construct a diagnostic model for patients with mild cognitive impairment, or Alzheimer's disease, as well as a predictive model for the progression of 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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
- •Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
- •Agree to participate in this study and sign the informed consent form. And promise to abide by the research procedures, and cooperate with the implementation of the whole process of research
排除标准
- •Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
- •Uncorrectable visual or auditory impairment that hampers the completion of related examination.
结局指标
主要结局
The change of incidence of cognitive impairment
时间窗: baseline, 2 year, 4 year, 6 year, 8 year
Number of participants who covert to AD or mild cognitive impairment (MCI) will be recorded to calculate the incidence.
次要结局
- The change of Mini-Mental State Examination (MMSE)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of Auditory verbal learning test (AVLT)(baseline, 2 year, 4 year, 6 year, 8 year)
- Positron emission tomography (PET)-CT(baseline)
- The change of Montreal cognitive assessment-Basic (MoCA)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of Geriatric Depression Scale (GDS)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of 36-Item Short Form Survey (SF-36)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of MRI neuroimaging(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of Activities of daily living (ADL)(baseline, 2 year, 4 year, 6 year, 8 year)
- The change of speech information(baseline, 2 year, 4 year, 6 year, 8 year)