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

Aging Clinical Trial

— MLP  

Official title:

Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566538
• Other study ID #: RC31/12/0400
• Secondary ID: 2012-A00943-40
• Status: Completed
• Start date: May 22, 2013
• Est. completion date: June 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test of memorizing and restitution of words	French version of the Rey auditory verbal learning test	7 years after the first assessment
Secondary	Level of cardiovascular risk	Number of risk factors	7 years after the first assessment
Secondary	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).	10 years after the first assessment
Secondary	WAIS-DSST	Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest	7 years after the first assessment
Secondary	Stroop test		7 years after the first assessment