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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05441865
Other study ID # 82003539
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 30, 2024

Study information

Verified date April 2024
Source Peking University Sixth Hospital
Contact Xiaozhen Lv, Ph.D
Phone 86-10-62723705
Email lxz120300@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 8000
Est. completion date December 30, 2024
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility For the cognitive trajectory cohort (the data had been collected): Inclusion Criteria: 1. Aged 65 or over at baseline; 2. With normal cognitive function at baseline (score = 18 on the Chinese version of Mini-Mental State Examination, MMSE); 3. Had at least one domain information about cardiovascular risk factors (hypertension, diabetes, dyslipidemia, obesity, exercise, diet and smoking) at baseline; 4. Completed cognitive function assessment at least twice during 3 waves following-up after baseline; 5. Provided informed consent voluntarily. Exclusion Criteria: 1. Aged <65; 2. had a history of dementia or MMSE score < 18 at baseline; 3. Without more than once cognitive function assessment during the follow-up; 4. Refused to participate the survey. For the neuroimaging sample, who would be enrolled by this study: Inclusion Criteria: 1. Aged 55-80; 2. Right-handed; 3. Primary school education or above, with normal communication ability; 4. No complaints of cognitive impairment or decline; 5. MMSE score = 26; 6. Clinical dementia rating (CDR) =0; 7. Provided informed consent voluntarily. Exclusion Criteria: 1. Severe visual or hearing impairment, difficult to complete cognitive function assessment; 2. Had contraindications to magnetic resonance examination, such as claustrophobia, cardiac pacemaker and artificial heart valve; 3. Had cardiovascular diseases (such as myocardial infarction and unstable angina pectoris), severe respiratory diseases, malignant tumors, renal failure and other serious physical diseases; 4. Had diseases that could affect cognitive function, such as hypothyroidism, syphilis, vitamin B12 deficiency and anemia; 5. Had a history of any mental disease; 6. Had a history of cerebrovascular disease, or obvious space occupying lesions in the brain revealed by magnetic resonance examination; 7. Refused to participate the survey.

Study Design


Locations

Country Name City State
China Peking University Six Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Regression coefficients the influence of cardiovascular risk factors on cognitive change up to 10 years
Secondary the correlation coefficient the relationship among cognitive function score, value of cerebral blood flow, and functional connectivity strength baseline
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