- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02566538
Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging (MonaLisaPredor) (MLP)
Prospective Population Based Cohort Study on Cognitive and Cardiovascular Aging
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Toulouse, 프랑스, 31400
- Toulouse University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Test of memorizing and restitution of words
기간: 7 years after the first assessment
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French version of the Rey auditory verbal learning test
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7 years after the first assessment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Level of cardiovascular risk
기간: 7 years after the first assessment
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Number of risk factors
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7 years after the first assessment
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Level of cardiovascular risk
기간: 10 years after the first assessment
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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).
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10 years after the first assessment
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WAIS-DSST
기간: 7 years after the first assessment
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Wechsler Adult Intelligence Survey - Digit Symbol Substitution Subtest
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7 years after the first assessment
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Stroop test
기간: 7 years after the first assessment
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7 years after the first assessment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Vanina BONGARD, MD, PhD, University Hospital, Toulouse
- 연구 의자: Jean FERRIERES, MD PhD, University Hospital, Toulouse
- 연구 의자: Bruno VELLAS, MD PhD, University Hospital, Toulouse
- 연구 의자: Jean-Bernard RUIDAVETS, MD, University Hospital, Toulouse
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .