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Completed

NCT Number: NCT02566538

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

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.

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Key information

Conditions

Age range

42 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toulouse University Hospital

Toulouse, 31400, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging

Acronym: MLP

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2015
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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