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

Cognitive Decline Clinical Trial

— NEDICES2RISK  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03925844
• Other study ID #: PI18/00522
• Status: Active, not recruiting
• Start date: January 2014
• Est. completion date: June 2022

Study information

• Verified date: February 2021
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 965
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Risk Factor, Cardiovascular

Intervention

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.

Locations

Country	Name	City	State
Spain	Gerencia Atencion Primaria	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Hernández-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodríguez-Sánchez E, Boycheva E, Serrano JI, Gil-García JF, Trincado R, Sánchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, García García-Patino R, Benito-León J. Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study. JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the 37-item versión of the Mini-Mental State Examination score	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.	Baseline and 5 years
Primary	Change in the Clock-drawing test score	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.	Baseline and 5 years
Primary	Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score	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.	Baseline and 5 years
Primary	Change in the Semantic verbal fluency test score	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.	Baseline and 5 years
Primary	Change in the Six-object memory recall test score	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.	Baseline and 5 years
Primary	Change in the Mental Function Index score	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.	Baseline and 5 years
Primary	Change in the Trail Making Test score	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.	Baseline and 5 years
Primary	Change in the Word accentuation test score	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.	Baseline and 5 years
Secondary	New cases of cancer during the 5-years follow-up	It will be recorded all new cases of cancer during the 5-years follow-up	5 years