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

February 14, 2025 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Alzheimer Disease

Study Type

Observational

Enrollment (Actual)

1028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Amiens, France
    - CHU d'Amiens
  - Bobigny, France
    - AP-HP - CHU Avicenne
  - Bordeaux, France
    - CHU de Bordeaux - Pellegrin
  - Clermont-ferrand, France
    - CHU de Clermont-Ferrand
  - Colmar, France, 68000
    - Hôpitaux Civils de Colmar
  - Dijon, France
    - CHU de Dijon
  - Grenoble, France
    - CHU de Grenoble
  - Lille, France
    - CHU de Lille
  - Marseille, France
    - AP-HM
  - Montpellier, France
    - CHU de Montpellier
  - Nancy, France
    - CHU de Nancy
  - Nantes, France
    - CHU de Nantes
  - Nice, France
    - CHRU de Nice - Institut Claude Pompidou
  - Nice, France
    - CHU de Nice - Hopital de Cimiez
  - Paris, France
    - AP-HP - Hôpital BROCA
  - Paris, France
    - AP-HP La Pitié-Salpétrière
  - Paris, France
    - APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal
  - Pessac, France
    - CHU de Bordeaux
  - Poitiers, France
    - Chu de Poitiers
  - Rouen, France
    - CHU de Rouen
  - Saint-etienne, France
    - CHU de Saint-Étienne
  - Strasbourg, France
    - CHU de Strasbourg
  - Toulouse, France
    - CHU de Toulouse
  - Toulouse, France
    - CHU de Toulouse - Hôpital Purpan
  - Tours, France
    - Chu De Tours
  - Villeurbanne, France
    - Hospice Civil de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Outpatients from French Research Memory Centers and included in Memento cohort

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Individuals at high risk of developing Alzheimer's dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease) Time Frame: Each 12 months from baseline for 5 years	Each 12 months from baseline for 5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

Principal Investigator: Geneviève CHENE, Prof, CIC-1401 EC - ISPED - CHU de Bodeaux
Study Chair: Geneviève CHENE, Prof, CIC-1401 EC - ISPED - CHU de Bodeaux
Study Director: Carole DUFOUIL, Director, CIC-1401 EC - ISPED - CHU de Bodeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CHUBX 2019/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.