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

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ClinicalTrials.gov Identifier: NCT04111211
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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.


Condition or disease
Alzheimer Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Individuals at high risk of developing Alzheimer's dementia


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients from French Research Memory Centers and included in Memento cohort
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111211


Contacts
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Contact: Geneviève CHENE, Prof (0)5 57 57 13 92 ext +33 genevieve.chene@u-bordeaux.fr
Contact: Carole DUFOUIL, Director (0)5 57 57 14 23 ext +33 carole.dufouil@u-bordeaux.fr

Locations
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Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Geneviève CHENE, Prof CIC-1401 EC - ISPED - CHU de Bodeaux
Study Chair: Geneviève CHENE, Prof CIC-1401 EC - ISPED - CHU de Bodeaux
Study Director: Carole DUFOUIL, Director CIC-1401 EC - ISPED - CHU de Bodeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04111211    
Other Study ID Numbers: CHUBX 2019/16
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Alzheimer's disease
related disorders
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Cognition Disorders
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders