Cognitive ImpairmentDECRIVAMNCT01327196
Cognitive Impairment and Cardiovascular Risk in Older
An observational study of Cognitive Impairment and Cardiovascular Risk Factor, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
The objective of this project is to study cognitive yields in people of the town of Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive impairment in order to detect mild cognitive impairment and study the relationship between the clinical situation and cardiovascular… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Cardiovascular Risk Factor
- How many people
- 327 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Dec 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca
Who may be able to join
- lives in the municipality of Salamanca
- over 65 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Mild Cognitive Impairment in People Older Than 65 Years of Age and Its Relationship to Cardiovascular Risk Factors (DECRIVAM)
The objective of this project is to study cognitive yields in people of the town of Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive impairment in order to detect mild cognitive impairment and study the relationship between the clinical situation and cardiovascular risk factors. It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca which took part in a survey prior to partner health needs of the elderly of 65 years in the municipality of Salamanca. This was a stratified sampling as stratum considering the area of health. The results of this study are expected to evidence the extent of the problem of cognitive decline in the population over 65 years. It is also expected to determine the relationship between the co-morbidity in this problem and specific factors of cardiovascular risk in this group of population.
Read the detailed description
A random sample population, the information obtained has a validity superior to other studies in which the sample has not followed very strict criteria of selection.
Protocol for measurement:
- variable demographic partner
- vascular risk factors
- co-morbidity
- functional level for the activities of daily life
- cognitive performance in attention, memory, language, praxias, gnosias (abbreviated neuropsychological battery)
Through a battery short neuropsychological specially adapted for the study of older people will carry out a study of the cognitive performance in people older than 65 years of age and will try to establish how much influence the controlled variables of cardiovascular risk.
- Conditions
- Cognitive Impairment, Cardiovascular Risk Factor
- Keywords
- dementia, cardiovascular risk, elderly, aging, older 65-100 years
- Medical subject headings
- Cognitive Dysfunction, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of risk factors cardiovascular
Measured: Prevalence of risk factors cardiovascular
Secondary outcomes (1)
neuropsychological assessment
Measured: neuropsychological assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo de Investigación de Atención Primaria de Castilla y León
- Responsible party
- Sponsor
- Investigators
- MºVictoria Perea-Bartolome, MD, Principal investigator, Fundacion INFOSALUDEmiliano Rodriguez-Sanchez, MD, Study director, Fundacion INFOSALUD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327196
- Sponsor's protocol ID
- BIO39/SA04/10
- Acronym
- DECRIVAM
- Status last verified
- Sep 2014
- First submitted
- 30 Mar 2011
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Perea-Bartolome MV, Garcia-Garcia R, Ladera-Fernandez V, Mora-Simon S, Patino-Alonso MC, Almanza-Guerra TJ, Agudo-Conde C, Muriel-Diez MP, Rodriguez-Sanchez E. Detection of mild cognitive impairment in people older than 65 years of age and its relationship to cardiovascular risk factors (DECRIVAM). BMC Public Health. 2011 Jun 27;11:504. doi: 10.1186/1471-2458-11-504.
PubMed 21708036
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Mild Cognitive Impairment in People Older Than 65 Years of Age and Its Relationship to Cardiovascular Risk Factors (DECRIVAM)
- ClinicalTrials.gov ID
- NCT01327196
- Acronym / sponsor ID
- DECRIVAM / BIO39/SA04/10
- Conditions
- Cognitive Impairment, Cardiovascular Risk Factor
- Keywords
- dementia, cardiovascular risk, elderly, aging, older 65-100 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Grupo de Investigación de Atención Primaria de Castilla y León
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 2011 (estimated)
- 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.
The objective of this project is to study cognitive yields in people of the town of Salamanca over 65, with particular emphasis on the acquisition of the initial symptoms of cognitive impairment in order to detect mild cognitive impairment and study the relationship between the clinical situation and cardiovascular risk factors. It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca which took part in a survey prior to partner health needs of the elderly of 65 years in the municipality of Salamanca. This was a stratified sampling as stratum considering the area of health. The results of this study are expected to evidence the extent of the problem of cognitive decline in the population over 65 years. It is also expected to determine the relationship between the co-morbidity in this problem and specific factors of cardiovascular risk in this group of population.
Detailed description
A random sample population, the information obtained has a validity superior to other studies in which the sample has not followed very strict criteria of selection.
Protocol for measurement:
- variable demographic partner
- vascular risk factors
- co-morbidity
- functional level for the activities of daily life
- cognitive performance in attention, memory, language, praxias, gnosias (abbreviated neuropsychological battery)
Through a battery short neuropsychological specially adapted for the study of older people will carry out a study of the cognitive performance in people older than 65 years of age and will try to establish how much influence the controlled variables of cardiovascular risk.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- It will depart from a reference population of 420 people older than 65 years living in the municipality of Salamanca
Key inclusion criteria (2 listed)
- lives in the municipality of Salamanca
- over 65 years of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of risk factors cardiovascular
Time frame: Prevalence of risk factors cardiovascular
1 secondary outcome
neuropsychological assessment
Time frame: neuropsychological assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 21708036Perea-Bartolome MV, Garcia-Garcia R, Ladera-Fernandez V, Mora-Simon S, Patino-Alonso MC, Almanza-Guerra TJ, Agudo-Conde C, Muriel-Diez MP, Rodriguez-Sanchez E. Detection of mild cognitive impairment in people older than 65 years of age and its relationship to cardiovascular risk factors (DECRIVAM). BMC Public Health. 2011 Jun 27;11:504. doi: 10.1186/1471-2458-11-504.
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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.
MºVictoria Perea-Bartolome, MD principal investigator
Fundacion INFOSALUD
Emiliano Rodriguez-Sanchez, MD study director
Fundacion INFOSALUD
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 Cognitive Impairment and Cardiovascular Risk Factor, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 24 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of risk factors cardiovascular (time frame: Prevalence of risk factors cardiovascular). 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 NCT01327196, which also lists 1 linked publication.
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 24 Feb 2020.