Cardiovascular Risk Factors and Cognitive Trajectories

March 24, 2025 updated by: Xiaozhen LV, Peking University Sixth Hospital

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

3372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China, 100191
        • Peking University Six Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regression coefficients
Time Frame: up to 10 years
the influence of cardiovascular risk factors on cognitive change
up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the correlation coefficient
Time Frame: baseline
the relationship among cognitive function score, value of cerebral blood flow, and functional connectivity strength
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xiaozhen Lv, Peking University Six Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

April 1, 2024

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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