Cognitive Impairment Cohort Study of the Elderly Population in SheMountain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-26

Study Completion Date

2031-01-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Dementia Neurodegenerative Diseases Cognitive Impairment Mild Cognitive Impairment

Keywords

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Alzheimer disease Mild cognitive impairment cohort Disease Progression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. All genders and all ethnic groups aged 60 and above with permanent residence in Tianma area, SheMountain Town, Songjiang District (suburbs), Shanghai.
2. Agree to collect neuropsychiatric scales, biological samples, imaging and other examination information.
3. 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

1. Suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate
2. Uncorrectable visual or auditory impairment that hampers the completion of related examination.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Gang Wang, MD, PhD

Role: CONTACT

Phone: 086-021-64370045

Email: [email protected]

Facility Contacts

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Jintao Wang

Role: primary

Other Identifiers

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SheMountain-01

Identifier Type: -

Identifier Source: org_study_id