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Completed

NCT Number: NCT05441865

Cardiovascular Risk Factors and Cognitive Trajectories

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Six Hospital

Beijing, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Regression coefficients

    Time frame: up to 10 years

    the influence of cardiovascular risk factors on cognitive change

Secondary outcomes

  1. the correlation coefficient

    Time frame: baseline

    the relationship among cognitive function score, value of cerebral blood flow, and functional connectivity strength

Sponsors and collaborators

Lead sponsor

Peking University Sixth Hospital

Other

Registry information

Official study title

The Influence and Potential Mechanism of Cardiovascular Risk Factors on the Cognitive Trajectories Among Cognitively Intact Older Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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