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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03925844

Recruitment Status Active, not recruiting

First Posted April 24, 2019

Last update posted August 9, 2019

Study Description

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.

  • Condition or Disease:Risk Factor, Cardiovascular
    Cognitive Decline
  • Intervention/Treatment: Other: Classification according to the cardiovascular risk
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 965 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years: an Estimation Model Based on Spanish Population. NEDICES-2-RISK Study.
  • Actual Study Start Date: January 2014
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: June 2022
Outcome Measures
  • Primary Outcome Measures: 1. Change in the 37-item versión of the Mini-Mental State Examination score [ Time Frame: 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.
  • 2. Change in the Clock-drawing test score [ Time Frame: 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.
  • 3. Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score [ Time Frame: 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.
  • 4. Change in the Semantic verbal fluency test score [ Time Frame: 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.
  • 5. Change in the Six-object memory recall test score [ Time Frame: 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.
  • 6. Change in the Mental Function Index score [ Time Frame: 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.
  • 7. Change in the Trail Making Test score [ Time Frame: 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.
  • 8. Change in the Word accentuation test score [ Time Frame: 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: 1. New cases of cancer during the 5-years follow-up [ Time Frame: 5 years ]
    It will be recorded all new cases of cancer during the 5-years follow-up
Eligibility Criteria
  • Ages Eligible for Study: 55 to 74 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.
Criteria

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.

Contacts and Locations
Contacts
Locations

Spain
Gerencia Atencion Primaria
Madrid

Sponsors and Collaborators

Gerencia de Atención Primaria, Madrid

Investigators

Principal Investigator: Ester Tapias-Merino, MD Gerencia de Atención Primaria, Madrid

More Information