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

Alzheimer Disease Clinical Trial

— Memento-Plus  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04111211
• Other study ID #: CHUBX 2019/16
• Status: Active, not recruiting
• Start date: December 3, 2019
• Est. completion date: June 2025

Study information

• Verified date: December 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1025
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Dysfunction

Locations

Country	Name	City	State
France	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
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	Toulouse
France	CHU de Toulouse - Hôpital Purpan	Toulouse
France	CHU de Tours	Tours
France	Hospice Civil de Lyon	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality		Each 12 months from baseline for 5 years
Secondary	Loss of autonomy based on functional activity assessment		Each 12 months from baseline for 5 years
Secondary	Rate of cognitive decline based on change in cognitive performances		Each 12 months from baseline for 5 years
Secondary	Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)		Each 12 months from baseline for 5 years
Secondary	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
Secondary	Incidence of prodromal AD (Pre-symptomatic dementia)		Each 12 months from baseline for 5 years
Secondary	Incidence of institutionalization		Each 12 months from baseline for 5 years