AgingMLPNCT02566538
Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor)
An observational study of Aging, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Aging is a long term process, starting early in life, and progressively affecting various functions and organs. Cardiovascular diseases and cognitive impairment are two conditions related to advancing age and sharing common risk factors. Read more about this study
- Who is it for?
- Ages 42 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2013to Jun 2018
- 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 42 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The design is a prospective cohort study carried out among 1500 men and women from the general population, aged 42-89 years,and living in South-western France. Except for participants aged 80-89 years, all participants have been previously assessed in 2005-2007, as regard to their psychometric and cognitive performances and level of cardiovascular risk, as part of the Mona Lisa study.
Who may be able to join
- Men and women aged 42-79 years, living in South-western France, who participated in the Mona Lisa Study (2005-2007) (in the Mona Lisa study, participants were selected by drawing on polling lists)
- Men and women aged 80-89 years, living in South-western France, selected by drawing on polling lists.
Who cannot join
- Subject who refuses to participate (who refuses to sign the inform consent)
- Subject not affiliated to a health assurance system
- Subject with altered cognitive functioning compromising the understanding of the information on the study, and not accompanied by a trusted third party.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging
Aging is a long term process, starting early in life, and progressively affecting various functions and organs. Cardiovascular diseases and cognitive impairment are two conditions related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a population-based prospective cohort study carried out to develop risk prediction algorithms aimed at identifying people who are the most likely to develop impaired psychometric and cognitive functioning and impaired cardiovascular risk, in the coming years.
Read the detailed description
The study is aimed at identifying predictors of impaired changes in psychometric and cognitive performances and level of cardiovascular risk, over a seven-year period, and to develop risk prediction algorithms. Main secondary objectives are to study response to psychometric and cognitive tests according to age, and to estimate the prevalence of the frailty syndrome according to age.
The design is a prospective cohort study carried out among 1500 men and women from the general population, aged 42-89 years, and living in South-western France. Except for participants aged 80-89 years, all participants have been previously assessed in 2005-2007, as regard to their psychometric and cognitive performances and level of cardiovascular risk, as part of the Mona Lisa study.
Data collection includes a detailed questionnaire on previous medical history, drug intake, education level, and life habits; a standardised clinical examination; psychometric tests (word list learning test, digit symbol substitution test, word fluency test and Stroop test), and a fasting blood sample. Level of cardiovascular risk and frailty syndrome were assessed.
- Conditions
- Aging
- Keywords
- Cohort study, psychometric tests, cognitive function, cardiovascular risk, prediction algorithm
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of memorizing and restitution of words
French version of the Rey auditory verbal learning test
Measured: 7 years after the first assessment
Secondary outcomes (4)
Level of cardiovascular risk
Number of risk factors
Measured: 7 years after the first assessment
Level of cardiovascular risk
10-years risk of cardiovascular event. A first assessment was performed in 2005-2007. A second one will be performed as part of the current study (2013-2016).
Measured: 10 years after the first assessment
WAIS-DSST
Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest
Measured: 7 years after the first assessment
Stroop test
Measured: 7 years after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start22 May 2013
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanina BONGARD, MD, PhD, Principal investigator, University Hospital, ToulouseJean FERRIERES, MD PhD, Study chair, University Hospital, ToulouseBruno VELLAS, MD PhD, Study chair, University Hospital, ToulouseJean-Bernard RUIDAVETS, MD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566538
- Sponsor's protocol ID
- RC31/12/0400
- Other IDs
- 2012-A00943-40
- Acronym
- MLP
- Status last verified
- Jul 2020
- First submitted
- 24 May 2013
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging
- ClinicalTrials.gov ID
- NCT02566538
- Acronym / sponsor ID
- MLP / RC31/12/0400
- Conditions
- Aging
- Keywords
- Cohort study, psychometric tests, cognitive function, cardiovascular risk, prediction algorithm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 22 May 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Oct 2015 (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.
Aging is a long term process, starting early in life, and progressively affecting various functions and organs. Cardiovascular diseases and cognitive impairment are two conditions related to advancing age and sharing common risk factors. The Mona Lisa- PREDOR study is a population-based prospective cohort study carried out to develop risk prediction algorithms aimed at identifying people who are the most likely to develop impaired psychometric and cognitive functioning and impaired cardiovascular risk, in the coming years.
Detailed description
The study is aimed at identifying predictors of impaired changes in psychometric and cognitive performances and level of cardiovascular risk, over a seven-year period, and to develop risk prediction algorithms. Main secondary objectives are to study response to psychometric and cognitive tests according to age, and to estimate the prevalence of the frailty syndrome according to age.
The design is a prospective cohort study carried out among 1500 men and women from the general population, aged 42-89 years, and living in South-western France. Except for participants aged 80-89 years, all participants have been previously assessed in 2005-2007, as regard to their psychometric and cognitive performances and level of cardiovascular risk, as part of the Mona Lisa study.
Data collection includes a detailed questionnaire on previous medical history, drug intake, education level, and life habits; a standardised clinical examination; psychometric tests (word list learning test, digit symbol substitution test, word fluency test and Stroop test), and a fasting blood sample. Level of cardiovascular risk and frailty syndrome were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 42 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The design is a prospective cohort study carried out among 1500 men and women from the general population, aged 42-89 years,and living in South-western France. Except for participants aged 80-89 years, all participants have been previously assessed in 2005-2007, as regard to their psychometric and cognitive performances and level of cardiovascular risk, as part of the Mona Lisa study.
Key inclusion criteria (2 listed)
- Men and women aged 42-79 years, living in South-western France, who participated in the Mona Lisa Study (2005-2007) (in the Mona Lisa study, participants were selected by drawing on polling lists)
- Men and women aged 80-89 years, living in South-western France, selected by drawing on polling lists.
Key exclusion criteria (3 listed)
- Subject who refuses to participate (who refuses to sign the inform consent)
- Subject not affiliated to a health assurance system
- Subject with altered cognitive functioning compromising the understanding of the information on the study, and not accompanied by a trusted third party.
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
Test of memorizing and restitution of words
Time frame: 7 years after the first assessment
French version of the Rey auditory verbal learning test
4 secondary outcomes
Level of cardiovascular risk
Time frame: 7 years after the first assessment
Level of cardiovascular risk
Time frame: 10 years after the first assessment
WAIS-DSST
Time frame: 7 years after the first assessment
Stroop test
Time frame: 7 years after the first 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 31 Jul 2020.
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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.
Vanina BONGARD, MD, PhD principal investigator
University Hospital, Toulouse
Jean FERRIERES, MD PhD study chair
University Hospital, Toulouse
Bruno VELLAS, MD PhD study chair
University Hospital, Toulouse
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 Aging, run by University Hospital, Toulouse at 1 site in France.
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 3 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 31 Jul 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 France. 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?
Test of memorizing and restitution of words (time frame: 7 years after the first assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2020; AzTrials last refreshed its copy on 2 Nov 2026.