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 |
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Recruitment Status :
Recruiting
First Posted : October 1, 2019
Last Update Posted : February 21, 2021
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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.
| Condition or disease |
|---|
| Alzheimer Disease |
| 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 |
| Group/Cohort |
|---|
| Individuals at high risk of developing Alzheimer's dementia |
- 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 ]
- Mortality [ Time Frame: Each 12 months from baseline for 5 years ]
- Loss of autonomy based on functional activity assessment [ Time Frame: Each 12 months from baseline for 5 years ]
- Rate of cognitive decline based on change in cognitive performances [ Time Frame: Each 12 months from baseline for 5 years ]
- Incidence of neurovascular and cardiovascular events (Stroke and Coronary events) [ Time Frame: Each 12 months from baseline for 5 years ]
- 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)
- Incidence of prodromal AD (Pre-symptomatic dementia) [ Time Frame: Each 12 months from baseline for 5 years ]
- Incidence of institutionalization [ Time Frame: Each 12 months from baseline for 5 years ]
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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 |
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
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
| 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 |
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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 |
| 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: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alzheimer's disease related disorders Mild Cognitive Impairment |
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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 |