Cognitive Impairment Cohort Study of the Elderly Population in SheMountain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia, Neurodegenerative Diseases, Cognitive Impairment. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort
Overview
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.
Primary outcome measures
- The change of incidence of cognitive impairment [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
Secondary outcome measures (10)
- The change of Mini-Mental State Examination (MMSE) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Montreal cognitive assessment-Basic (MoCA) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Auditory verbal learning test (AVLT) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Geriatric Depression Scale (GDS) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of 36-Item Short Form Survey (SF-36) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of MRI neuroimaging [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- Positron emission tomography (PET)-CT [Time frame: baseline]
- The change of blood concentration of Phosphorylated Tau, Concentration of Amyloid β (Aβ) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of Activities of daily living (ADL) [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
- The change of speech information [Time frame: baseline, 2 year, 4 year, 6 year, 8 year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT05667935 · SheMountain-01