Cognitive Impairment Cohort Study of the Elderly Population in YuGarden

March 15, 2024 updated by: Ruijin Hospital

Shanghai Cognitive Impairment Study of the Elderly Population: YuGarden Cohort

The goal of this prospective observational research with an 8-year follow-up is to study the cognitive changes in the elderly in YuGarden community, Shanghai, China.

The main questions it aims to answer are:

  • incidence of cognitive impairment in community (converting to mild cognitive impairment or Alzheimer's disease)
  • to build a predictive model for the progression of cognitive impairment

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a prospective observational study which involves a large sample cohort of the elderly aged 60 to 85 years in YuGarden community, Shanghai, China, with an 8-year follow-up. Demographic information, peripheral organs evaluation (facial expression, hearing, OCT angiography), cognitive tests (MMSE, ADL), biospecimen (peripheral blood, urine, feces, gingival crevicular fluid), speech information, neuroimaging (MRI, PET) and electroencephalogram (EEG) will be collected and analyzed. Follow-up visits will be conducted twice a year for 4 visits and each visit includes cognitive tests, biospecimen collection, speech test, MRI and EEG. The primary outcome is the incidence of cognitive impairment indicating people who convert to mild cognitive impairment (MCI) or Alzheimer's disease (AD). Furthermore, a predictive model for the progression of cognitive impairment will be constructed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1872

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Gang Wang
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The population in this study includes permanent residence in YuGarden community in Shanghai with all genders and all ethnic groups aged between 60 and 85.

Description

Inclusion Criteria:

  1. The participants are community-dwelling elderly people living in Yuyuan community, Shanghai, aged 60-85 years old, with no gender restriction.
  2. Non-AD patients.
  3. The participants can complete the cognitive tests, biological sample collection, speech tests, neuroimaging examinations, and cooperate with the implementation of the whole process of research.
  4. The participants agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

  1. Participants who are suffering from severe mental illness, tumor cachexia, severe liver and kidney dysfunction and other serious physical diseases and unable to cooperate with the examination.
  2. Participants who have visual or auditory impairment that hampers the completion of related examination.
  3. Situations when magnetic resonance imaging or other examinations are contraindicated.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of cognitive impairment
Time Frame: 8 years
Number of participants who covert to mild cognitive impairment (MCI) or AD will be recorded to calculate the incidence.
8 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 30-point questionnaire used to measure cognitive function (orientation, registration, attention, calculation, recall, language, repetition, complex commands). 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 Barthel Index for Activities of Daily Living (ADL)
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
The Barthel Index for Activities of Daily Living is an ordinal scale which measures a person's ability to complete activities of daily living (ADL). The Barthel Index measures the degree of assistance required by an individual on ten mobility and self-care ADL items. The ten items are scored with a number of points, and then a final score is calculated by summing the points awarded to each functional skill.
baseline, 2 year, 4 year, 6 year, 8 year
The change of blood biomarkers
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
p-tau 181, p-tau 217, pE-Aβ3-42, Aβ40, Aβ42, GFAP and NFL will be detected.
baseline, 2 year, 4 year, 6 year, 8 year
The change of urine biomarkers
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
The metabolomic markers in urine will be detected by mass spectrum analysis.
baseline, 2 year, 4 year, 6 year, 8 year
The change of feces biomarkers
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
The metabolomic markers in feces will be detected by mass spectrum analysis.
baseline, 2 year, 4 year, 6 year, 8 year
The change of gingival crevicular fluid biomarkers
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
The metabolomic profiles of gingival crevicular fluid will be detected by mass spectrum analysis.
baseline, 2 year, 4 year, 6 year, 8 year
The change of electroencephalogram (EEG)
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
Electroencephalogram (EEG) is used to measure electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. Recorded frequencies include alpha, beta, delta and theta band power. The EEG signatures of people with cognitive impairment will be further analyzed, and its longitudinal changes will be observed.
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 the self-developed ASR speech analysis software (China software copyright number: 2016RS164680) will be used for speech analysis.
baseline, 2 year, 4 year, 6 year, 8 year
The change of structural MRI
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
Structural MRI data will be acquired and analyzed through high-resolution T1-weighted MRI and diffusion tensor imaging (DTI).
baseline, 2 year, 4 year, 6 year, 8 year
The change of functional MRI
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
Functional MRI data will be acquired and analyzed through blood oxygenation level dependent (BOLD) imaging.
baseline, 2 year, 4 year, 6 year, 8 year
The change of magnetic susceptibility
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
Magnetic susceptibility data will be acquired and analyzed through quantitative susceptibility mapping (QSM).
baseline, 2 year, 4 year, 6 year, 8 year
The change of perfusion MR imaging
Time Frame: baseline, 2 year, 4 year, 6 year, 8 year
Perfusion imaging data will be acquired and analyzed through arterial spin labeling (ASL).
baseline, 2 year, 4 year, 6 year, 8 year
Positron emission tomography (PET)
Time Frame: baseline
PET including FDG-PET, Aβ-PET, Tau-PET will be used to detect brain β-amyloid and tau burden.
baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gang Wang, MD, PhD, 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YuGarden-01

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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