Cognitive Impairment Cohort Study of the Elderly Population in SheMountain (SheMountain)

December 28, 2022 updated by: Ruijin Hospital

Shanghai Cognitive Impairment Study of the Elderly Population: SheMountain Cohort

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Gang Wang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population in this study includes permanent residence in SheMountain Town, Songjiang District (suburbs), Shanghai with all genders and all ethnic groups aged 60 and above.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 2 year, 4 year, 6 year, 8 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Mini-Mental State Examination (MMSE)
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
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
MoCA is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity.
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
AVLT is a screening instrument used to assess the function of memory. The score in long-term memory (N5) ranges from 0 to 12, with lower scores indicating greater disease severity.
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
GDS is a neuropsychological scale used to assess the level of depression. The total score ranges from 0 to 30, with higher scores indicating greater disease severity.
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 Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. And it consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
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
Evaluation of brain MRI by high-resolution structural T1 imaging, diffusion tensor imaging, and blood oxygenation level dependent (BOLD) imaging.
baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)-CT
Time Frame: baseline
Including AV45-PET, FDG-PET, Tau-PET, GLP-1R PET, Cholinergic receptor probe (ASEM) PET will be used to detect the amyloid, Tau burden and AD related GLP-1R as well as Cholinergic receptor change.
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
Blood serum p-tau 181, p-tau 217, Aβ40 and Aβ42at baseline will be tested. The higher blood p-tau is a strong predictor for AD.
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
ADL is a scale used in healthcare to refer to people's daily self-care activities. Eight factors are rated to produce an overall score on a point scale of 0 to 100. The lower the score the more independence in living.
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
Voice data collection, use a voice recorder to collect the patient's description of "stealing biscuit map" language, and save it in SWV format. And use self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis.
baseline, 2 year, 4 year, 6 year, 8 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 26, 2022

Primary Completion (Anticipated)

December 31, 2030

Study Completion (Anticipated)

January 31, 2031

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Estimate)

December 29, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SheMountain-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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