Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor) (MLP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02566538|
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : July 31, 2020
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||520 participants|
|Official Title:||Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging|
|Actual Study Start Date :||May 22, 2013|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||June 2018|
- Test of memorizing and restitution of words [ Time Frame: 7 years after the first assessment ]French version of the Rey auditory verbal learning test
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566538
|Toulouse University Hospital|
|Toulouse, France, 31400|
|Principal Investigator:||Vanina BONGARD, MD, PhD||University Hospital, Toulouse|
|Study Chair:||Jean FERRIERES, MD PhD||University Hospital, Toulouse|
|Study Chair:||Bruno VELLAS, MD PhD||University Hospital, Toulouse|
|Study Chair:||Jean-Bernard RUIDAVETS, MD||University Hospital, Toulouse|