Cognitive ImpairmentNCT06686186
Hainan Community Cognition Cohort
An observational study of Cognitive Impairment and Dementia, run by Hainan Medical College at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Dementia, Age Problems
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2022to 31 Dec 2053
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community residents aged 60 years or older in Hainan Province, China
Who may be able to join
- Age 60 years and above
- Lived in the community for more than 6 months
- Signed the informed consent form
Who cannot join
- Cannot complete the survey
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hainan Medical University
Haikou, Hainan, 571199
Jindong Ding Petersen, PHD, +8613256406001, dingjindong@muhn.edu.cn
About this study
Official title: A Prospective Cohort of Hainan Community Elderly Population with Cognitive Impairment
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.
Read the detailed description
This is a community-based prospective cohort study in Hainan Province, China. Subjects are individuals aged 60 years and above who have lived in the communities for more than six months and have signed informed consent. The research have been initialed in 2023 and aims to identify the risk factors associated with cognitive impairment, to develop software for cognitive enhancement and physical rehabilitation training. The study includes three steps: first, to conduct cognitive function screening in 16 communities in four districts (Xiuying, Meilan, Longhua, and Qiongshan) of Haikou City and establish a database for the elderly in tropical regions; second, to identify risk factors associated with cognitive impairment in the elderly population; finally, to independently develop a software for cognitive function enhancement and physical rehabilitation training.
- Conditions
- Cognitive Impairment, Dementia, Age Problems
- Being tested
- No Intervention: Observational Cohort
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
There were no interventions in our cohort. The subjects of our cohort were and will be followed up at the regular intervals.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: An average of 1 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start16 Dec 2022
- Primary completion31 Dec 2053 (estimated)
- Study completion31 Dec 2053 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Hainan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University, Xuanwu Hospital, Beijing, Fudan University
- Responsible party
- Principal investigator, Jindong Ding Petersen, Hainan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686186
- Sponsor's protocol ID
- Hainan Medical University
- Other IDs
- ZDYF2024SHFZ064, 82360673, XRC2022005
- Status last verified
- Sep 2024
- First submitted
- 23 Oct 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort of Hainan Community Elderly Population with Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06686186
- Acronym / sponsor ID
- Hainan Medical University
- Conditions
- Cognitive Impairment, Dementia, Age Problems
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hainan Medical CollegeUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Hainan Medical University, Xuanwu Hospital, Beijing, Fudan University
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 31 Dec 2053 (estimated)
- Study completion
- 31 Dec 2053 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a community-based prospective cohort study in Hainan Province, China. Subjects are individuals aged 60 years and above who have lived in the communities for more than six months and have signed informed consent. The research have been initialed in 2023 and aims to identify the risk factors associated with cognitive impairment, to develop software for cognitive enhancement and physical rehabilitation training. The study includes three steps: first, to conduct cognitive function screening in 16 communities in four districts (Xiuying, Meilan, Longhua, and Qiongshan) of Haikou City and establish a database for the elderly in tropical regions; second, to identify risk factors associated with cognitive impairment in the elderly population; finally, to independently develop a software for cognitive function enhancement and physical rehabilitation training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community residents aged 60 years or older in Hainan Province, China
Key inclusion criteria (3 listed)
Key exclusion criteria (1 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThere were no interventions in our cohort. The subjects of our cohort were and will be followed up at the regular intervals. | Other | – |
Primary outcome
The prevalence and incidence of cognitive impairment base on the communities
Time frame: An average of 1 to 2 years
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.
The prevalence and incidence of dementia using a population-based survey
Time frame: An average of 1 to 2 years
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.
The conversion rate of normal to cognitive impairment
Time frame: An average of 1 to 2 years
Percentage of enrolled population that convert from normal to cognitive impairment
The conversion rate of cognitive impairment to dementia
Time frame: An average of 1 to 2 years
Percentage of enrolled population that convert from cognitive impairment to dementia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Dementia, run by Hainan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jindong Ding Petersen, PHD. (089866893772, dingjindong@muhn.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence and incidence of cognitive impairment base on the communities (time frame: An average of 1 to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.