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

Completed

• Conditions: Aging

• Registration Number: NCT02566538
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-05-22
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-02
• Primary Completion: 2018-05
• Study Completion: 2018-06
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-29
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test of memorizing and restitution of words	7 years after the first assessment	French version of the Rey auditory verbal learning test

Secondary Outcome Measures

Name	Time	Method
WAIS-DSST	7 years after the first assessment	Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest
Stroop test	7 years after the first assessment
Level of cardiovascular risk	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).

Trial Locations

Locations (1)

Toulouse University Hospital; 🇫🇷 Toulouse, France