Clinical trial NCT04111211: Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
Official title: Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
related disorders
Mild Cognitive Impairment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 1028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients from French Research Memory Centers and included in Memento cohort

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)
timeFrame: Each 12 months from baseline for 5 years
Secondary outcomes:
measure: Mortality
timeFrame: Each 12 months from baseline for 5 years
measure: Loss of autonomy based on functional activity assessment
timeFrame: Each 12 months from baseline for 5 years
measure: Rate of cognitive decline based on change in cognitive performances
timeFrame: Each 12 months from baseline for 5 years
measure: Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)
timeFrame: Each 12 months from baseline for 5 years
measure: Quality of life: EQ-5D (EUROQOL)
timeFrame: Each 12 months from baseline for 5 years
measure: Incidence of prodromal AD (Pre-symptomatic dementia)
timeFrame: Each 12 months from baseline for 5 years
measure: Incidence of institutionalization
timeFrame: Each 12 months from baseline for 5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Bobigny
country: France
facility: AP-HP - CHU Avicenne
city: Bordeaux
country: France
facility: CHU de Bordeaux - Pellegrin
city: Clermont-ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de Lille
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHRU de Nice - Institut Claude Pompidou
city: Nice
country: France
facility: CHU de Nice - Hôpital de Cimiez
city: Paris
country: France
facility: AP-HP - Hôpital BROCA
city: Paris
country: France
facility: Ap-Hp La Pitié-Salpêtrière
city: Paris
country: France
facility: APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal
city: Pessac
country: France
facility: CHU de Bordeaux
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Villeurbanne
country: France
facility: Hospice Civil de Lyon
Study officials:
affiliation: CIC-1401 EC - ISPED - CHU de Bodeaux
name: Geneviève CHENE, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: CIC-1401 EC - ISPED - CHU de Bodeaux
name: Geneviève CHENE, Prof
role: STUDY_CHAIR
affiliation: CIC-1401 EC - ISPED - CHU de Bodeaux
name: Carole DUFOUIL, Director
role: STUDY_DIRECTOR
References: