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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals at high risk of developing Alzheimer's dementia<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) |  | Each 12 months from baseline for 5 years | 
| Incidence of institutionalization |  | Each 12 months from baseline for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, related disorders, Mild Cognitive Impairment