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临床试验/NCT05441865
NCT05441865已完成不适用

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

Peking University Sixth Hospital1 个研究点 分布在 1 个国家目标入组 3,372 人开始时间: 2023年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,372
试验地点
1
主要终点
Regression coefficients

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Regression coefficients

时间窗: up to 10 years

the influence of cardiovascular risk factors on cognitive change

次要结局

  • the correlation coefficient(baseline)

研究者

发起方
Peking University Sixth Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaozhen LV

Associate Researcher

Peking University Sixth Hospital

研究点 (1)

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