Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT04111211
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2019-12-03
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1028

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	Each 12 months from baseline for 5 years
Quality of life: EQ-5D (EUROQOL)	Each 12 months from baseline for 5 years	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)
Loss of autonomy based on functional activity assessment	Each 12 months from baseline for 5 years
Rate of cognitive decline based on change in cognitive performances	Each 12 months from baseline for 5 years
Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)	Each 12 months from baseline for 5 years
Incidence of prodromal AD (Pre-symptomatic dementia)	Each 12 months from baseline for 5 years
Incidence of institutionalization	Each 12 months from baseline for 5 years

Trial Locations

Locations (26)

CHU de Dijon; 🇫🇷 Dijon, France

AP-HP - Hôpital BROCA; 🇫🇷 Paris, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Lille; 🇫🇷 Lille, France

CHU de Bordeaux - Pellegrin; 🇫🇷 Bordeaux, France

AP-HP - CHU Avicenne; 🇫🇷 Bobigny, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Hôpitaux Civils de Colmar; 🇫🇷 Colmar, France

CHU de Montpellier; 🇫🇷 Montpellier, France

AP-HM; 🇫🇷 Marseille, France

CHU de Nancy; 🇫🇷 Nancy, France

CHRU de Nice - Institut Claude Pompidou; 🇫🇷 Nice, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Nice - Hôpital de Cimiez; 🇫🇷 Nice, France

Ap-Hp La Pitié-Salpêtrière; 🇫🇷 Paris, France

CHU de Bordeaux; 🇫🇷 Pessac, France

APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal; 🇫🇷 Paris, France

CHU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse, 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

Hospice Civil de Lyon; 🇫🇷 Villeurbanne, France

CHU de Tours; 🇫🇷 Tours, France

CHU d'Amiens; 🇫🇷 Amiens, France