Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years

• Conditions: Risk Factor, Cardiovascular; Cognitive Decline

• Registration Number: NCT03925844
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief Summary

This study assesses whether people's cardiovascular risk influences cognitive performance in later years. To do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2019-03-24
• Study First Submitted QC: 2019-04-21
• Study First Posted: 2019-04-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-07
• Last Update Posted: 2021-02-09
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 965

Inclusion Criteria

• population aged 55 to 74 years from NEDICES 2 study
• to have signed informed consent
• to have done the neuropsicological assessment

Exclusion Criteria

• to have a dementia diagnosis at baseline.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score	Baseline and 5 years	The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening instrument for depression, self-administared, which records depressive symptoms and their different manifestations in the last 7 days and each symptom is classified in four frequency levels. The score ranges from 20 to 80. Higher values are considered a worse outcome.
Change in the Semantic verbal fluency test score	Baseline and 5 years	The Semantic verbal fluency test evaluates semantic memory, executive and verbal planning capabilities. It is used a shorter version that evaluates the number of elements in a category (animals). There is a minimum score of 0, there is not a maximun score. Higher values are considered a better outcome.
Change in the Trail Making Test score	Baseline and 5 years	The Trail Making Test is a visuomotor integration test from which is collected the score, the number of mistakes and the performance time. The score ranges from 1 to 20. Higher values are considered a better outcome. A shorter performance time and fewer mistakes are considered a better outcome.
Change in the 37-item versión of the Mini-Mental State Examination score	Baseline and 5 years	The 37 item Version of the Mini-Mental State Examination is a Spanish adapted version of the original MMSE by Folstein. It contains 37 items. Includes temporal and spatial orientation, memory, attention, calculus, language, object recognition, elementary commands and visuoconstructive capacity. The minimun score is 0 and the maximum score is 37 points. Higher values are considered a better outcome.
Change in the Six-object memory recall test score	Baseline and 5 years	The Six-Object Memory Recall Tests shows six sheets with common objects and explores object recognition, immediate recall and delayed memory after 5 minutes. Both, object recognition, inmediate recall and delayed memory have a scale ranging from 0 to 6.Therefore, the total score has a minimun score of 0 and a maximum score of 18 points. Higher values are considered a better outcome.
Change in the Mental Function Index score	Baseline and 5 years	The Mental Function Index is a questionnaire that evaluates 11 instrumental activities of daily life and competencies in the home and occupational and social functioning that is administered to a family member or caregiver. It explores 11 sections, each one with three levels of functionality. The minimum score is 0 and the maximum score is 33. Higher values are considered a worse outcome.
Change in the Clock-drawing test score	Baseline and 5 years	The Clock-drawing test is a brief test that explores comprehension, concentration, visual memory and abstraction and visuoconstructive praxis. The subject is asked to draw a clock from memory on a blank sheet, including the numbers and hands at a fixed time. The minimum score is 0 and the maximum score is 4. Higher values are considered a better outcome. Performance time is recorded. A shorter time is considered a better outcome.
Change in the Word accentuation test score	Baseline and 5 years	The Word accentuation test is a verbal intelligence test in which the participant reads 30 unusual words that are shown to him without tildes and whose accentuation he has to do correctly. The score ranges from 0 to 30. Higher values are considered a better outcome.

Secondary Outcome Measures

Name	Time	Method
New cases of cancer during the 5-years follow-up	5 years	It will be recorded all new cases of cancer during the 5-years follow-up

Trial Locations

Locations (1)

Gerencia Atencion Primaria; 🇪🇸 Madrid, Spain