Clinical trial NCT02566538: Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor)
Official title: Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Keywords: Cohort study
psychometric tests
cognitive function
cardiovascular risk
prediction algorithm
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-10-02
Enrollment: 520
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Test of memorizing and restitution of words
timeFrame: 7 years after the first assessment
Secondary outcomes:
measure: Level of cardiovascular risk
timeFrame: 7 years after the first assessment
measure: Level of cardiovascular risk
timeFrame: 10 years after the first assessment
measure: WAIS-DSST
timeFrame: 7 years after the first assessment
measure: Stroop test
timeFrame: 7 years after the first assessment
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Vanina BONGARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Toulouse
name: Jean FERRIERES, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital, Toulouse
name: Bruno VELLAS, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital, Toulouse
name: Jean-Bernard RUIDAVETS, MD
role: STUDY_CHAIR
References: