- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05441865
Cardiovascular Risk Factors and Cognitive Trajectories
The Influence and Potential Mechanism of Cardiovascular Risk Factors on the Cognitive Trajectories Among Cognitively Intact Older Adults
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Beijing, China, 100191
- Peking University Six Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
For the cognitive trajectory cohort (the data had been collected):
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
Inclusion Criteria:
- Aged 55-80;
- 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.
Exclusion Criteria:
- Severe visual or hearing impairment, difficult to complete cognitive function assessment;
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Regression coefficients
Time Frame: up to 10 years
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the influence of cardiovascular risk factors on cognitive change
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up to 10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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the correlation coefficient
Time Frame: baseline
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the relationship among cognitive function score, value of cerebral blood flow, and functional connectivity strength
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaozhen Lv, Peking University Six Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 82003539
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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