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

NCT ID: NCT02566538

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-22

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

42 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanina BONGARD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Jean FERRIERES, MD PhD

Role: STUDY_CHAIR

University Hospital, Toulouse

Bruno VELLAS, MD PhD

Role: STUDY_CHAIR

University Hospital, Toulouse

Jean-Bernard RUIDAVETS, MD

Role: STUDY_CHAIR

University Hospital, Toulouse

Locations

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Toulouse University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00943-40

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/12/0400

Identifier Type: -

Identifier Source: org_study_id

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