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Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor) (MLP)

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ClinicalTrials.gov Identifier: NCT02566538
Recruitment Status : Recruiting
First Posted : October 2, 2015
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief 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. 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.

Condition or disease
Aging

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.


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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging
Actual Study Start Date : May 22, 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018



Primary Outcome Measures :
  1. Test of memorizing and restitution of words [ Time Frame: 7 years after the first assessment ]
    French version of the Rey auditory verbal learning test


Secondary Outcome Measures :
  1. Level of cardiovascular risk [ Time Frame: 7 years after the first assessment ]
    Number of risk factors

  2. Level of cardiovascular risk [ Time Frame: 10 years after the first assessment ]
    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).

  3. WAIS-DSST [ Time Frame: 7 years after the first assessment ]
    Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest

  4. Stroop test [ Time Frame: 7 years after the first assessment ]

Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02566538


Contacts
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Contact: Vanina BONGARD, MD, PhD (0)5 61 14 59 49 ext 33 vanina.bongard@univ-tlse3.fr
Contact: Jean FERRIERES, MD PhD (0)5 61 14 59 49 ext 33 jean.ferrieres@univ-tlse3.fr

Locations
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France
Toulouse University Hospital Recruiting
Toulouse, France, 31400
Contact: Pierre-Jean OUSSET, MD    (0)5 61 77 85 82 ext 33    ousset.pj@chu-toulouse.fr   
Contact: Nathalie SASTRE, MD    (0)5 61 77 78 52 ext 33    sastre.n@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Vanina BONGARD, MD, PhD University Hospital, Toulouse
Study Chair: Jean FERRIERES, MD PhD University Hospital, Toulouse
Study Chair: Bruno VELLAS, MD PhD University Hospital, Toulouse
Study Chair: Jean-Bernard RUIDAVETS, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02566538     History of Changes
Other Study ID Numbers: RC31/12/0400
2012-A00943-40 ( Other Identifier: ANSM, ID-RCB )
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Keywords provided by University Hospital, Toulouse:
Cohort study
psychometric tests
cognitive function
cardiovascular risk
prediction algorithm