Normal CognitionNCT05441865
Cardiovascular Risk Factors and Cognitive Trajectories
An observational study of Normal Cognition and Cardiovascular Risk Factors, run by Peking University Sixth Hospital at 1 site in China.
Trial summary
The cognitive trajectory varies among non-demented older adults. In a 12-year follow-up study, we found approximately 5% participants presented rapid cognitive decline. Cardiovascular diseases increased the risk of cognitive decline. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Cognition, Cardiovascular Risk Factors, Cognitive Change
- How many people
- 3,372 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the cognitive trajectory cohort, the study population was those community-dwelling older adults with normal cognitive function, completed at least one domain information about cardiovascular risk factors at baseline, and completed cognitive function assessment at least twice during 3 waves following-up after baseline. For the neuroimaging sample, the study population was those community-dwelling older adults with normal cognitive function, without severe physical disease and mental disorders, could complete cognitive function assessment and MRI examination.
Who may be able to join
- Aged 65 or over at baseline;
- With normal cognitive function at baseline (score ≥ 18 on the Chinese version of Mini-Mental State Examination, MMSE);
- Had at least one domain information about cardiovascular risk factors (hypertension, diabetes, dyslipidemia, obesity, exercise, diet and smoking) at baseline;
- Completed cognitive function assessment at least twice during 3 waves following-up after baseline;
- Provided informed consent voluntarily.
- Aged 55-80;
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- Right-handed;
- Primary school education or above, with normal communication ability;
- No complaints of cognitive impairment or decline;
- MMSE score ≥ 26;
- Clinical dementia rating (CDR) =0;
- Provided informed consent voluntarily.
Who cannot join
- Aged <65;
- had a history of dementia or MMSE score < 18 at baseline;
- Without more than once cognitive function assessment during the follow-up;
- Refused to participate the survey.
- For the neuroimaging sample, who would be enrolled by this study:
- Severe visual or hearing impairment, difficult to complete cognitive function assessment;
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- Had contraindications to magnetic resonance examination, such as claustrophobia, cardiac pacemaker and artificial heart valve;
- Had cardiovascular diseases (such as myocardial infarction and unstable angina pectoris), severe respiratory diseases, malignant tumors, renal failure and other serious physical diseases;
- Had diseases that could affect cognitive function, such as hypothyroidism, syphilis, vitamin B12 deficiency and anemia;
- Had a history of any mental disease;
- Had a history of cerebrovascular disease, or obvious space occupying lesions in the brain revealed by magnetic resonance examination;
- Refused to participate the survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence and Potential Mechanism of Cardiovascular Risk Factors on the Cognitive Trajectories Among Cognitively Intact Older Adults
The cognitive trajectory varies among non-demented older adults. In a 12-year follow-up study, we found approximately 5% participants presented rapid cognitive decline. Cardiovascular diseases increased the risk of cognitive decline. However, the influence of cardiovascular risk factors on cognitive decline remained inconsistent. Besides, the potential mechanism of the cardiovascular risk factors and cognitive function has not been fully investigated. Therefore, the proposed program will include two sub-studies. The first sub-study will use the longitudinal data from the Chinese Longitudinal Healthy Longevity Survey to evaluate the influence of cardiovascular risk factors on the trajectories of cognitive function. The second sub-study will recruit cognitive intact older adults with different levels of cardiovascular risk factors. The association among cardiovascular risk factors, cerebral blood flow, brain functional connectivity and cognitive function will be investigated with structural equation modeling. The findings of the proposed program will provide novel insight on preventing cognitive decline from the angle of maintaining healthy vascular function, and will provide evidence in elucidating the potential neurovascular mechanism between cardiovascular risk factors and cognitive function.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cognitive trajectory cohort | Th cognitive trajectory cohort, based on CLHLS dataset, will be used to evaluate the influence of cardiovascular risk factors on the cognitive trajectories among cognitively intact older adults | |
| neuroiming sample | The neuroiming sample, including cognitively intact older adults with MRI data, will be used to explore the potential mechanism of the cardiovascular risk factors and cognitive function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression coefficients
the influence of cardiovascular risk factors on cognitive change
Measured: up to 10 years
Secondary outcomes (1)
the correlation coefficient
the relationship among cognitive function score, value of cerebral blood flow, and functional connectivity strength
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start1 Apr 2023
- Primary completion30 Nov 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal CognitionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Sixth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaozhen LV, Peking University Sixth Hospital
- Investigators
- Xiaozhen Lv, Principal investigator, Peking University Six Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441865
- Sponsor's protocol ID
- 82003539
- Status last verified
- Apr 2024
- First submitted
- 27 Jun 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence and Potential Mechanism of Cardiovascular Risk Factors on the Cognitive Trajectories Among Cognitively Intact Older Adults
- ClinicalTrials.gov ID
- NCT05441865
- Acronym / sponsor ID
- 82003539
- Conditions
- Normal Cognition, Cardiovascular Risk Factors, Cognitive Change, Cerebral Blood Flow, FMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,372 participants (actual)
- Lead sponsor
- Peking University Sixth HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 1 Jul 2022 (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.
The cognitive trajectory varies among non-demented older adults. In a 12-year follow-up study, we found approximately 5% participants presented rapid cognitive decline. Cardiovascular diseases increased the risk of cognitive decline. However, the influence of cardiovascular risk factors on cognitive decline remained inconsistent. Besides, the potential mechanism of the cardiovascular risk factors and cognitive function has not been fully investigated. Therefore, the proposed program will include two sub-studies. The first sub-study will use the longitudinal data from the Chinese Longitudinal Healthy Longevity Survey to evaluate the influence of cardiovascular risk factors on the trajectories of cognitive function. The second sub-study will recruit cognitive intact older adults with different levels of cardiovascular risk factors. The association among cardiovascular risk factors, cerebral blood flow, brain functional connectivity and cognitive function will be investigated with structural equation modeling. The findings of the proposed program will provide novel insight on preventing cognitive decline from the angle of maintaining healthy vascular function, and will provide evidence in elucidating the potential neurovascular mechanism between cardiovascular risk factors and cognitive function.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive trajectory cohort | – | –Th cognitive trajectory cohort, based on CLHLS dataset, will be used to evaluate the influence of cardiovascular risk factors on the cognitive trajectories among cognitively intact older adults |
| neuroiming sample | – | –The neuroiming sample, including cognitively intact older adults with MRI data, will be used to explore the potential mechanism of the cardiovascular risk factors and cognitive function. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the cognitive trajectory cohort, the study population was those community-dwelling older adults with normal cognitive function, completed at least one domain information about cardiovascular risk factors at baseline, and completed cognitive function assessment at least twice during 3 waves following-up after baseline. For the neuroimaging sample, the study population was those community-dwelling older adults with normal cognitive function, without severe physical disease and mental disorders, could complete cognitive function assessment and MRI examination.
Key inclusion criteria (12 listed)
- Aged 65 or over at baseline;
- With normal cognitive function at baseline (score ≥ 18 on the Chinese version of Mini-Mental State Examination, MMSE);
- Had at least one domain information about cardiovascular risk factors (hypertension, diabetes, dyslipidemia, obesity, exercise, diet and smoking) at baseline;
- Completed cognitive function assessment at least twice during 3 waves following-up after baseline;
- Provided informed consent voluntarily.
Key exclusion criteria (12 listed)
- Aged <65;
- had a history of dementia or MMSE score < 18 at baseline;
- Without more than once cognitive function assessment during the follow-up;
- Refused to participate the survey.
- Severe visual or hearing impairment, difficult to complete cognitive function assessment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regression coefficients
Time frame: up to 10 years
the influence of cardiovascular risk factors on cognitive change
1 secondary outcome
the correlation coefficient
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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. This study is not recruiting at the moment.
Xiaozhen Lv principal investigator
Peking University Six Hospital
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 Normal Cognition and Cardiovascular Risk Factors, run by Peking University Sixth Hospital 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 27 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression coefficients (time frame: up to 10 years). 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 27 Mar 2025.