Cardiovascular Risk Factors and Cognitive Trajectories

• Sponsor: Peking University Sixth Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05441865
• Collaborator: (none)
• Enrollment: 8,000
• Location: 1
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 222.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Normal Cognition; Cardiovascular Risk Factors; Cognitive Change; Cerebral Blood Flow; fMRI

Study Design

• Study Type: Observational
• Anticipated Enrollment: 8000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The Influence and Potential Mechanism of Cardiovascular Risk Factors on the Cognitive Trajectories Among Cognitively Intact Older Adults
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 30, 2023
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Regression coefficients [up to 10 years]

   the influence of cardiovascular risk factors on cognitive change

Secondary Outcome Measures

1. the correlation coefficient [baseline]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Six Hospital	Beijing		China	100191

Sponsors and Collaborators

• Peking University Sixth Hospital

Investigators

• Principal Investigator: Xiaozhen Lv, Peking University Six Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaozhen LV, Associate Researcher, Peking University Sixth Hospital
• ClinicalTrials.gov Identifier: NCT05441865
• Other Study ID Numbers: 82003539
• First Posted: Jul 1, 2022
• Last Update Posted: Jul 1, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 1, 2022