Predictive Factors of Autonomy Loss in Real-life Cohort
MEM-AURA
Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
1 other identifier
interventional
5,400
1 country
5
Brief Summary
The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments. The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France. The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedStudy Start
First participant enrolled
September 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2032
ExpectedMay 2, 2022
April 1, 2022
3.5 years
March 25, 2019
April 25, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Functional autonomy level
The Lawton Instrumental Activities of Daily Living (IADL)
from 6 months to 12 months interval
Functional autonomy level
The Disability Assessment of Dementia (DAD-6)
from 6 months to 12 months interval
Functional autonomy level
The New-AGGIR (French national score for dependency assessment)
from 6 months to 12 months interval
Study Arms (1)
Patients with subjective cognitive complaint or neurocognitive
EXPERIMENTAL: Real-life cohort patients with subjective cognitive complaint or neurocognitive disorders undergoing medical examination in memory centers, and for whom extensive evaluations will be performed for the study
Interventions
This is study carried out in current practice. Patients are undergoing a medical examination in a memory center, with extensive and systematic evaluations for the study involving the following tests: IADL, DAD6, New AGGIR, NPI, and mini-Zarit) assessing the functions (autonomy, behavior and caregiver burden).
Eligibility Criteria
You may qualify if:
- Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
- Patients living at home or in housing
- Patients with memory impairment, at all stage of the disease
You may not qualify if:
- Patients in institution
- Patients under legal protection
- Patients with a hearing or visual impairment, which prevents carrying out examinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hôpital Dugoujon
Caluire-et-Cuire, 69300, France
Centre Hospitalier Lyon Sud
Lyon, 69310, France
Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est
Lyon, France
CHU Saint-Etienne
Saint-Etienne, 42055, France
Centre Mémoire de Ressources et de Recherche de Lyon
Villeurbanne, 69100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Krolak-Salmon, PhD
Centre Mémoire de Ressources et de Recherche
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2019
First Posted
March 28, 2019
Study Start
September 9, 2020
Primary Completion
March 1, 2024
Study Completion (Estimated)
March 1, 2032
Last Updated
May 2, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share