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)

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.

Study Overview

• Status: Recruiting
• Conditions: Memory Disorders
• Intervention / Treatment: Other: no intervention

• Study Type: Interventional
• Enrollment (Anticipated): 5400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre Krolak-Salmon, PhD; Phone Number: 04 72 43 20 50; Email: pierre.krolak-salmon@chu-lyon.fr

Study Locations

• France
  • Caluire-et-Cuire, France, 69300
    • Recruiting
    • Hôpital Dugoujon
    • Contact: Sylvain Gaujard, MD; Phone Number: +33 04 72 00 15 32; Email: sylvain.gaujard@chu-lyon.fr
  • Lyon, France, 69310
    • Recruiting
    • Centre Hospitalier Lyon Sud
    • Contact: Marc Bonnefoy, PhD; Phone Number: 04 78 86 15 81; Email: marc.bonnefoy@chu-lyon.fr
  • Lyon, France
    • Recruiting
    • Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est
    • Contact: Virginie Desestret, PhD; Email: virginie.desestret@chu-lyon.fr
  • Saint-Étienne, France, 42055
    • Recruiting
    • CHU Saint-Etienne
    • Contact: Jean-Claude Getenet, MD; Phone Number: 04 77 12 78 05; Email: j.claude.getenet@chu-st-etienne.fr
  • Villeurbanne, France, 69100
    • Recruiting
    • Centre Mémoire de Ressources et de Recherche de Lyon
    • Contact: Pierre Krolak-Salmon, PhD; Phone Number: 04 72 43 20 50; Email: pierre.krolak-salmon@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients in institution
• Patients under legal protection
• Patients with a hearing or visual impairment, which prevents carrying out examinations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with subjective cognitive complaint or neurocognitive; : 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	Other: no intervention; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pierre Krolak-Salmon, PhD, Centre Mémoire de Ressources et de Recherche

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2032

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: 69HCL18_0613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No