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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

Tracking Information
First Submitted Date September 27, 2019
First Posted Date October 1, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date December 3, 2019
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 27, 2019)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2019)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: September 27, 2019)
  • 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 ]
  • Neurovascular and cardiovascular events (Stroke and Coronary events) [ Time Frame: Each 12 months from baseline for 5 years ]
  • Quality of life [ Time Frame: Each 12 months from baseline for 5 years ]
    EQ-5D (EUROQOL) questionnaire
  • Prodromal AD (Pre-symptomatic dementia) [ Time Frame: Each 12 months from baseline for 5 years ]
  • Institutionalization [ Time Frame: Each 12 months from baseline for 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Outpatients from French Research Memory Centers and included in Memento cohort
Condition Alzheimer Disease
Intervention Not Provided
Study Groups/Cohorts Individuals at high risk of developing Alzheimer's dementia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 27, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04111211
Other Study ID Numbers CHUBX 2019/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Not Provided
Investigators
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
PRS Account University Hospital, Bordeaux
Verification Date December 2019