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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04111211
Other study ID # CHUBX 2019/16
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 3, 2019
Est. completion date June 2025

Study information

Verified date December 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive. Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial. To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers). This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1025
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants aged over 18 year-old - Being included in Memento cohort - Affiliated person or beneficiary of a social security scheme. - Participants capable of expressing non objection - Non objection expressed by the tutor for participants under tutorship - Non objection expressed by the participant assisted by their guardian for participants under guardianship - Non objection expressed by the trusted person (in accordance with art. L1111-6 of Code de la Santé Publique) for participants without the capacity to express non-objection and who are not under legal protection measure Exclusion Criteria: - Expressing opposition to participate in Memento-Plus

Study Design


Locations

Country Name City State
France CHU d'Amiens Amiens
France AP-HP - CHU Avicenne Bobigny
France CHU de Bordeaux - Pellegrin Bordeaux
France CHU de Clermont-Ferrand Clermont-ferrand
France Hôpitaux Civils de Colmar Colmar
France CHU de Dijon Dijon
France CHU de Grenoble Grenoble
France CHU de Lille Lille
France AP-HM Marseille
France CHU de Montpellier Montpellier
France CHU de Nancy Nancy
France CHU de Nantes Nantes
France CHRU de Nice - Institut Claude Pompidou Nice
France CHU de Nice - Hôpital de Cimiez Nice
France AP-HP - Hôpital BROCA Paris
France Ap-Hp La Pitié-Salpêtrière Paris
France APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal Paris
France CHU de Bordeaux Pessac
France CHU de Poitiers Poitiers
France CHU de Rouen Rouen
France CHU de Saint-Etienne Saint-etienne
France CHU de Strasbourg Strasbourg
France CHU de Toulouse Toulouse
France CHU de Toulouse - Hôpital Purpan Toulouse
France CHU de Tours Tours
France Hospice Civil de Lyon Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease) Each 12 months from baseline for 5 years
Secondary Mortality Each 12 months from baseline for 5 years
Secondary Loss of autonomy based on functional activity assessment Each 12 months from baseline for 5 years
Secondary Rate of cognitive decline based on change in cognitive performances Each 12 months from baseline for 5 years
Secondary Incidence of neurovascular and cardiovascular events (Stroke and Coronary events) Each 12 months from baseline for 5 years
Secondary Quality of life: EQ-5D (EUROQOL) EQ-5D (EUROQOL) questionnaire Subscales: VAS patient's self-rated health (0=worst, 100=best), mobility, self-care, usual activities, pain/discomfort and anxiety/depression (rated as no problems, slight problems, moderate problems, severe problems and extreme problems) Each 12 months from baseline for 5 years
Secondary Incidence of prodromal AD (Pre-symptomatic dementia) Each 12 months from baseline for 5 years
Secondary Incidence of institutionalization Each 12 months from baseline for 5 years
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