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CompletedNCT02566538MLPUpdated Jul 31, 2020

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

An observational study in Aging, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 42 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-31.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
520
Ages
42 Years to 89 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Aging

Keywords

  • Cohort study
  • psychometric tests
  • cognitive function
  • cardiovascular risk
  • prediction algorithm
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In context

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
42 Years to 89 Years
Sexes eligible
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
520 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Test of memorizing and restitution of words

    French version of the Rey auditory verbal learning test

    Time frame: 7 years after the first assessment

Secondary outcomes

  1. Level of cardiovascular risk

    Number of risk factors

    Time frame: 7 years after the first assessment

  2. 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).

    Time frame: 10 years after the first assessment

  3. WAIS-DSST

    Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest

    Time frame: 7 years after the first assessment

  4. Stroop test

    Time frame: 7 years after the first assessment

07

Study locations

1 site
  • Toulouse University Hospital
    Toulouse, 31400, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02566538
Lead sponsor
University Hospital, Toulouse
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Oct 2, 2015
Start date
May 22, 2013
Primary completion
May 2018
Completion
Jun 2018
Last update
Jul 31, 2020

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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