Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Ruijin Hospital
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- The change of incidence of cognitive impairment
- Status
- Not Yet Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The change of incidence of cognitive impairment
Time Frame: 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.
Secondary Outcomes
- 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)