CClinicalTrials.gg
CompletedNCT04111211Memento-PlusUpdated Feb 17, 2025

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

An observational study in Alzheimer Disease, sponsored by University Hospital, Bordeaux. Completed at 26 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,028
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer Disease

Keywords

  • Alzheimer's disease
  • related disorders
  • Mild Cognitive Impairment
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 1,028 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients from French Research Memory Centers and included in Memento cohort

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

Exclusion Criteria:

  • Expressing opposition to participate in Memento-Plus
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,028 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals at high risk of developing Alzheimer's dementia
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Mortality

    Time frame: Each 12 months from baseline for 5 years

  2. Loss of autonomy based on functional activity assessment

    Time frame: Each 12 months from baseline for 5 years

  3. Rate of cognitive decline based on change in cognitive performances

    Time frame: Each 12 months from baseline for 5 years

  4. Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)

    Time frame: Each 12 months from baseline for 5 years

  5. 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)

    Time frame: Each 12 months from baseline for 5 years

  6. Incidence of prodromal AD (Pre-symptomatic dementia)

    Time frame: Each 12 months from baseline for 5 years

  7. Incidence of institutionalization

    Time frame: Each 12 months from baseline for 5 years

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Study locations

26 sites
  • 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, 68000, 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 - Hôpital Purpan
    Toulouse, France
  • CHU de Toulouse
    Toulouse, France
  • CHU de Tours
    Tours, France
  • Hospice Civil de Lyon
    Villeurbanne, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04111211
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Oct 1, 2019
Start date
Dec 3, 2019
Primary completion
Dec 20, 2024
Completion
Dec 20, 2024
Last update
Feb 17, 2025

Study contacts

Geneviève CHENE, Prof
principal investigator · CIC-1401 EC - ISPED - CHU de Bodeaux
Geneviève CHENE, Prof
study chair · CIC-1401 EC - ISPED - CHU de Bodeaux
Carole DUFOUIL, Director
study director · CIC-1401 EC - ISPED - CHU de Bodeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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