Cardiovascular Risk Factors and Cognitive Trajectories

NCT05441865 | Completed

• 1 other identifier: 82003539
• Study Type: observational
• Target: 3,372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Normal Cognition; Cardiovascular Risk Factors; Cognitive Change; Cerebral Blood Flow; FMRI

Outcome Measures

Primary Outcomes (1)

• Regression coefficients

  the influence of cardiovascular risk factors on cognitive change

  up to 10 years

Secondary Outcomes (1)

• the correlation coefficient

  baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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;

Sponsors & Collaborators

• Peking University Sixth Hospital: lead

Study Sites (1)

Peking University Six Hospital

Beijing, 100191, China

Location

Study Officials

• Xiaozhen Lv

  Peking University Six Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: April 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 27, 2025

Record last verified: 2024-04

Locations

CN (1)