NCT02566538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

4.9 years

First QC Date

May 24, 2013

Last Update Submit

July 29, 2020

Conditions

Keywords

Cohort studypsychometric testscognitive functioncardiovascular riskprediction algorithm

Outcome Measures

Primary Outcomes (1)

  • Test of memorizing and restitution of words

    French version of the Rey auditory verbal learning test

    7 years after the first assessment

Secondary Outcomes (4)

  • Level of cardiovascular risk

    7 years after the first assessment

  • Level of cardiovascular risk

    10 years after the first assessment

  • WAIS-DSST

    7 years after the first assessment

  • Stroop test

    7 years after the first assessment

Eligibility Criteria

Age42 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toulouse University Hospital

Toulouse, 31400, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Vanina BONGARD, MD, PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

October 2, 2015

Study Start

May 22, 2013

Primary Completion

May 1, 2018

Study Completion

June 1, 2018

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations