Risk Factor, CardiovascularNEDICES2RISKNCT03925844
Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years
An observational study of Risk Factor, Cardiovascular and Cognitive Decline, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 55 to 74 years
- Conditions the study is for
- Risk Factor, Cardiovascular, Cognitive Decline
- What is being tested?
- Classification according to the cardiovascular risk
- How many people
- 965 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jun 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Adult, Older adult
Study population: The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.
Who may be able to join
- population aged 55 to 74 years from NEDICES 2 study
- to have signed informed consent
- to have done the neuropsicological assessment
Who cannot join
- to have a dementia diagnosis at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Risk Factor, Cardiovascular, Cognitive Decline
- Being tested
- Classification according to the cardiovascular risk
- Keywords
- Cardiovascular risk prediction models, Framingham risk function, FRESCO risk function, risk function, cognitive aging, prevention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classification according to the cardiovascular riskOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
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.
Measured: Baseline and 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study startJan 2014
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Risk Factor, CardiovascularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 965 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ester Tapias Merino, Gerencia de Atención Primaria, Madrid
- Investigators
- Ester Tapias-Merino, MD, Principal investigator, Gerencia de Atención Primaria, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925844
- Sponsor's protocol ID
- PI18/00522
- Acronym
- NEDICES2RISK
- Status last verified
- Feb 2021
- First submitted
- 24 Mar 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon 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.
PubMed 30632964Tapias-Merino E, De Hoyos-Alonso MDC, Contador-Castillo I, Rodriguez-Sanchez E, Sanz-Cuesta T, Becerro-Munoz CM, Hernandez-Gallego J, Vega-Quiroga S, Bermejo-Pareja F; NEDICES2-RISK Group. Cardiovascular risk in subjects over 55 years of age and cognitive performance after five years. NEDICES2-RISK study. Study protocol. PLoS One. 2022 Nov 28;17(11):e0274589. doi: 10.1371/journal.pone.0274589. eCollection 2022.
PubMed 36441718
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03925844
- Acronym / sponsor ID
- NEDICES2RISK / PI18/00522
- Conditions
- Risk Factor, Cardiovascular, Cognitive Decline
- Keywords
- Cardiovascular risk prediction models, Framingham risk function, FRESCO risk function, risk function, cognitive aging, prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 965 participants (estimated)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.
Key inclusion criteria (3 listed)
- population aged 55 to 74 years from NEDICES 2 study
- to have signed informed consent
- to have done the neuropsicological assessment
Key exclusion criteria (1 listed)
- to have a dementia diagnosis at baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Classification according to the cardiovascular riskAll 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. | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
New cases of cancer during the 5-years follow-up
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Background: PubMed 30632964Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon 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.
- Derived from this study: PubMed 36441718Tapias-Merino E, De Hoyos-Alonso MDC, Contador-Castillo I, Rodriguez-Sanchez E, Sanz-Cuesta T, Becerro-Munoz CM, Hernandez-Gallego J, Vega-Quiroga S, Bermejo-Pareja F; NEDICES2-RISK Group. Cardiovascular risk in subjects over 55 years of age and cognitive performance after five years. NEDICES2-RISK study. Study protocol. PLoS One. 2022 Nov 28;17(11):e0274589. doi: 10.1371/journal.pone.0274589. eCollection 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ester Tapias-Merino, MD principal investigator
Gerencia de Atención Primaria, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factor, Cardiovascular and Cognitive Decline, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 37-item versión of the Mini-Mental State Examination score (time frame: Baseline and 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03925844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.