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Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years (NEDICES2RISK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925844
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ester Tapias Merino, Gerencia de Atención Primaria, Madrid

Study Description
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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 Intervention/treatment
Risk Factor, Cardiovascular Cognitive Decline Other: Classification according to the cardiovascular risk

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 965 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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
Groups and Cohorts
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Intervention Details:
  • Other: Classification according to the cardiovascular risk
    All patients are cognitively assessed at the beginning of the study and their cardiovascular risk is calculated. After 5 years of follow-up, patients are re-evaluated cognitively and their cardiovascular risk is recalculated.

Outcome Measures
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925844


Locations
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Spain
Gerencia Atencion Primaria
Madrid, Spain, 28033
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Investigators
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Principal Investigator: Ester Tapias-Merino, MD Gerencia de Atención Primaria, Madrid
  Study Documents (Full-Text)

Documents provided by Ester Tapias Merino, Gerencia de Atención Primaria, Madrid:
Informed Consent Form  [PDF] February 12, 2019
Study Protocol and Statistical Analysis Plan  [PDF] February 7, 2019

More Information
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Publications:

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Responsible Party: Ester Tapias Merino, Clinical researcher, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT03925844    
Other Study ID Numbers: PI18/00522
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Beginning 3 months and ending 5 years following article publication
Access Criteria: Researchers who provide a methodologically sound proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ester Tapias Merino, Gerencia de Atención Primaria, Madrid:
Cardiovascular risk prediction models
Framingham risk function
FRESCO risk function
 risk function
cognitive aging
prevention
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders