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NCT Number: NCT04111211

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    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)

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: Memento-Plus

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2019
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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