Age ProblemBEAMNCT06394817
Beijing Disability Risk and Ageing Monitoring Study
An observational study of Age Problem and Disability, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a community-based prospective cohort study in Beijing, China. The study has been initialized in 2023 and enrolled older residents. This study aims to develop disability risk assessment standards and an early warning model for older adults. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Problem, Disability, Death
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to May 2063
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community residents aged 60 years or older in China
Who may be able to join
- Aged 60 years or older
- Lived in the community for more than 1 year
- 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
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Tang, M.D., Ph.D., 00861083199456, tangyi@xwhosp.org
About this study
This is a community-based prospective cohort study in Beijing, China. The study has been initialized in 2023 and enrolled older residents. This study aims to develop disability risk assessment standards and an early warning model for older adults.
Read the detailed description
This is a community-based prospective cohort study. Individuals who aged 60 years or older, lived in the communities for more than 1 year, and signed the informed consent form were enrolled in the present study. The study has been initialized in 2023 and aimed to develop an early warning model and a series of disability risk assessment methods for older adults. This work consists of three steps as following. First, we will build a community-based cohort and thus set up a database. Second, an intelligence model for disability risk assessment will be developed using the database. Third, a series of procedures will be established according to the risk assessment model.
- Conditions
- Age Problem, Disability, Death
- Being tested
- No intervention
- Keywords
- Disability, Ageing, Cohort
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Total | All subjects Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence and incidence of functional disability using a population-based survey
Functional disability was measured by Activities of Daily Living, cognitive function (Mini-Mental State Examination) and movement disorder（Short Physical Performance Battery) collected by questionnaires.The minimum value of the Activities of Daily Living is 0, and the maximum value is 100, the higher the score, the better the outcome.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.
Measured: An average of 1 to 2 years
The prevalence and incidence of mild cognitive impairment using a population-based survey
Mild cognitive impairment was measured using Mini-Mental State Examination 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 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 diagnosis of death or Clinical Dementia Rating scale. The minimum value of the Clinical Dementia Rating is 0, and the maximum value is 3, the higher the score, the worse the outcome.
Measured: An average of 1 to 2 years
The conversion rate of normal to mild cognitive impairment
Percentage of enrolled population that convert from normal to mild cognitive impairment
Measured: An average of 1 to 2 years
The conversion rate of mild cognitive impairment to dementia
Percentage of enrolled population that convert from mild cognitive impairment to dementia
Measured: An average of 1 to 2 years
The genetic and environmental factors for mild cognitive impairment and dementia at genomic and expression levels
Discover risk factors including genetic susceptibility loci (APOE genes and other risk genes) using gene sequencing, cardiovascular risk factors (blood glucose, cholesterol, homocysteine) using laboratory tests, and unhealthy lifestyle using questionnaire.
Measured: An average of 1 to 2 years
The biomarkers for normal, mild cognitive impairment, and dementia diagnosis
Humoral biomarkers are included Aβ42, Aβ40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine. Imaging biomarkers are included cerebral volume, glucose metabolism, amyloid and tau deposition of whole brain or hippocampus.
Measured: An average of 1 to 2 years
The prevalence and incidence of movement disorder using a population-based survey
Movement disorder was measured using Short Physical Performance Battery collected by questionnaire.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.
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 posted1 May 2024
- Study start20 Feb 2023
- Primary completionMay 2063 (estimated)
- Study completionMay 2063 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age ProblemStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, MD., PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394817
- Sponsor's protocol ID
- 2022234
- Acronym
- BEAM
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Disability Risk and Ageing Monitoring Study
- ClinicalTrials.gov ID
- NCT06394817
- Acronym / sponsor ID
- BEAM / 2022234
- Conditions
- Age Problem, Disability, Death
- Keywords
- Disability, Ageing, Cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- May 2063 (estimated)
- Study completion
- May 2063 (estimated)
- First posted
- 1 May 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 Beijing, China. The study has been initialized in 2023 and enrolled older residents. This study aims to develop disability risk assessment standards and an early warning model for older adults.
Detailed description
This is a community-based prospective cohort study. Individuals who aged 60 years or older, lived in the communities for more than 1 year, and signed the informed consent form were enrolled in the present study. The study has been initialized in 2023 and aimed to develop an early warning model and a series of disability risk assessment methods for older adults. This work consists of three steps as following. First, we will build a community-based cohort and thus set up a database. Second, an intelligence model for disability risk assessment will be developed using the database. Third, a series of procedures will be established according to the risk assessment model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total | – | Other: No interventionAll subjects |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community residents aged 60 years or older in China
Key inclusion criteria (3 listed)
- Aged 60 years or older
- Lived in the community for more than 1 year
- Signed the informed consent form
Key exclusion criteria (1 listed)
- Cannot complete the survey
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 interventionNo intervention | Other | Total |
Primary outcome
The prevalence and incidence of functional disability using a population-based survey
Time frame: An average of 1 to 2 years
Functional disability was measured by Activities of Daily Living, cognitive function (Mini-Mental State Examination) and movement disorder（Short Physical Performance Battery) collected by questionnaires.The minimum value of the Activities of Daily Living is 0, and the maximum value is 100, the higher the score, the better the outcome.The minimum value of the Mini-Mental State Examination is 0, and the maximum value is 30, the higher the score, the better the outcome.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.
The prevalence and incidence of mild cognitive impairment using a population-based survey
Time frame: An average of 1 to 2 years
Mild cognitive impairment was measured using Mini-Mental State Examination 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 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 diagnosis of death or Clinical Dementia Rating scale. The minimum value of the Clinical Dementia Rating is 0, and the maximum value is 3, the higher the score, the worse the outcome.
The conversion rate of normal to mild cognitive impairment
Time frame: An average of 1 to 2 years
Percentage of enrolled population that convert from normal to mild cognitive impairment
The conversion rate of mild cognitive impairment to dementia
Time frame: An average of 1 to 2 years
Percentage of enrolled population that convert from mild cognitive impairment to dementia
The genetic and environmental factors for mild cognitive impairment and dementia at genomic and expression levels
Time frame: An average of 1 to 2 years
Discover risk factors including genetic susceptibility loci (APOE genes and other risk genes) using gene sequencing, cardiovascular risk factors (blood glucose, cholesterol, homocysteine) using laboratory tests, and unhealthy lifestyle using questionnaire.
The biomarkers for normal, mild cognitive impairment, and dementia diagnosis
Time frame: An average of 1 to 2 years
Humoral biomarkers are included Aβ42, Aβ40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine. Imaging biomarkers are included cerebral volume, glucose metabolism, amyloid and tau deposition of whole brain or hippocampus.
The prevalence and incidence of movement disorder using a population-based survey
Time frame: An average of 1 to 2 years
Movement disorder was measured using Short Physical Performance Battery collected by questionnaire.The minimum value of the Short Physical Performance Battery is 0, and the maximum value is 12, the higher the score, the better the outcome.
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 20 Jun 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.
Yi Tang, MD., PhD principal investigator
Xuanwu Hospital, Beijing
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 Age Problem and Disability, run by Xuanwu Hospital, Beijing 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 20 Jun 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 Yi Tang, MD., PhD (00861083199456, tangyi@xwhosp.org), 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 functional disability using a population-based survey (time frame: An average of 1 to 2 years). The study lists 8 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 20 Jun 2024.