NCT06686186

Brief Summary

This is a community-based prospective cohort study in Hainan Province, China. The study was initialized in 2023 and included older residents for longitudinal follow-up. The research aims to identify risk factors as well as health and social outcomes that are associated with cognitive impairment in elderly populations, and independently develop AI-assisted software and applications for cognitive enhancement and physical rehabilitation training.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
337mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Dec 2022Dec 2053

Study Start

First participant enrolled

December 16, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
29.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2053

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2053

Last Updated

November 13, 2024

Status Verified

September 1, 2024

Enrollment Period

31.1 years

First QC Date

October 23, 2024

Last Update Submit

November 11, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • The prevalence and incidence of cognitive impairment base on the communities

    Mild cognitive impairment was measured using a Chinese version Mini-Mental State Examination, which was collected by questionnaire. The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the cognition outcome.

    An average of 1 to 2 years

  • The prevalence and incidence of dementia using a population-based survey

    Dementia was determined by diagnosis of hospitalization or Clinical Dementia Rating Scale (Montreal Cognitive Assessment, MoCA). The minimum value of the MoCA is 0, and the maximum value is 30, the higher the score, the better the outcome. In addition, subtypes of dementia will be based on the specific clinical diagnosis.

    An average of 1 to 2 years

  • The conversion rate of normal to cognitive impairment

    Percentage of enrolled population that convert from normal to cognitive impairment

    An average of 1 to 2 years

  • The conversion rate of cognitive impairment to dementia

    Percentage of enrolled population that convert from cognitive impairment to dementia

    An average of 1 to 2 years

Interventions

There were no interventions in our cohort. The subjects of our cohort were and will be followed up at the regular intervals.

Eligibility Criteria

Age60 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community residents aged 60 years or older in Hainan Province, China

You may qualify if:

  • Age 60 years and above
  • Lived in the community for more than 6 months
  • Signed the informed consent form

You may not qualify if:

  • Cannot complete the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan Medical University

Haikou, Hainan, 571199, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plan to collect blood samples from some participants

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Jindong Ding Petersen, PHD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2024

First Posted

November 13, 2024

Study Start

December 16, 2022

Primary Completion (Estimated)

December 31, 2053

Study Completion (Estimated)

December 31, 2053

Last Updated

November 13, 2024

Record last verified: 2024-09

Locations