NCT04111211

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,028

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

26 active sites

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

First Submitted

Initial submission to the registry

September 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 3, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

September 27, 2019

Last Update Submit

February 14, 2025

Conditions

Keywords

Alzheimer's diseaserelated disordersMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Mortality

    Each 12 months from baseline for 5 years

  • 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

  • Quality of life: EQ-5D (EUROQOL)

    Each 12 months from baseline for 5 years

  • +2 more secondary outcomes

Study Arms (1)

Individuals at high risk of developing Alzheimer's dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients from French Research Memory Centers and included in Memento cohort

You may qualify if:

  • 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

You may not qualify if:

  • Expressing opposition to participate in Memento-Plus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

CHU d'Amiens

Amiens, France

Location

AP-HP - CHU Avicenne

Bobigny, France

Location

CHU de Bordeaux - Pellegrin

Bordeaux, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

Hôpitaux Civils de Colmar

Colmar, 68000, France

Location

CHU de Dijon

Dijon, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de Lille

Lille, France

Location

AP-HM

Marseille, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

CHRU de Nice - Institut Claude Pompidou

Nice, France

Location

CHU de Nice - Hôpital de Cimiez

Nice, France

Location

AP-HP - Hôpital BROCA

Paris, France

Location

Ap-Hp La Pitié-Salpêtrière

Paris, France

Location

APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal

Paris, France

Location

CHU de Bordeaux

Pessac, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rouen

Rouen, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse - Hôpital Purpan

Toulouse, France

Location

CHU de Toulouse

Toulouse, France

Location

CHU de Tours

Tours, France

Location

Hospice Civil de Lyon

Villeurbanne, France

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Geneviève CHENE, Prof

    CIC-1401 EC - ISPED - CHU de Bodeaux

    PRINCIPAL INVESTIGATOR
  • Geneviève CHENE, Prof

    CIC-1401 EC - ISPED - CHU de Bodeaux

    STUDY CHAIR
  • Carole DUFOUIL, Director

    CIC-1401 EC - ISPED - CHU de Bodeaux

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2019

First Posted

October 1, 2019

Study Start

December 3, 2019

Primary Completion

December 20, 2024

Study Completion

December 20, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations