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

Overview

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.

Full Title of Study: “Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2018

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Level of cardiovascular risk
    • Time Frame: 7 years after the first assessment
    • Number of risk factors
  • 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).
  • WAIS-DSST
    • Time Frame: 7 years after the first assessment
    • Wechsler Adult Intelligence Survey – Digit Symbol Substitution Subtest
  • Stroop test
    • Time Frame: 7 years after the first assessment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 42 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Toulouse
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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
    • Jean-Bernard RUIDAVETS, MD, Study Chair, University Hospital, Toulouse

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