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Predictive Factors of Autonomy Loss in Real-life Cohort (MEM-AURA)

Primary Purpose

Memory Disorders

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
no intervention
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Memory Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital DugoujonRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier EstRecruiting
  • CHU Saint-EtienneRecruiting
  • Centre Mémoire de Ressources et de Recherche de LyonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with subjective cognitive complaint or neurocognitive

Arm Description

: 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

Outcomes

Primary Outcome Measures

Functional autonomy level
The Lawton Instrumental Activities of Daily Living (IADL)
Functional autonomy level
The Disability Assessment of Dementia (DAD-6)
Functional autonomy level
The New-AGGIR (French national score for dependency assessment)

Secondary Outcome Measures

Full Information

First Posted
March 25, 2019
Last Updated
April 25, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03894254
Brief Title
Predictive Factors of Autonomy Loss in Real-life Cohort
Acronym
MEM-AURA
Official Title
Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with subjective cognitive complaint or neurocognitive
Arm Type
Experimental
Arm Description
: 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
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
Functional autonomy level
Description
The Lawton Instrumental Activities of Daily Living (IADL)
Time Frame
from 6 months to 12 months interval
Title
Functional autonomy level
Description
The Disability Assessment of Dementia (DAD-6)
Time Frame
from 6 months to 12 months interval
Title
Functional autonomy level
Description
The New-AGGIR (French national score for dependency assessment)
Time Frame
from 6 months to 12 months interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Krolak-Salmon, PhD
Phone
04 72 43 20 50
Email
pierre.krolak-salmon@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak-Salmon, PhD
Organizational Affiliation
Centre Mémoire de Ressources et de Recherche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Dugoujon
City
Caluire-et-Cuire
ZIP/Postal Code
69300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Gaujard, MD
Phone
04 72 00 15 32
Ext
+33
Email
sylvain.gaujard@chu-lyon.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Bonnefoy, PhD
Phone
04 78 86 15 81
Email
marc.bonnefoy@chu-lyon.fr
Facility Name
Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginie Desestret, PhD
Email
virginie.desestret@chu-lyon.fr
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Claude Getenet, MD
Phone
04 77 12 78 05
Email
j.claude.getenet@chu-st-etienne.fr
Facility Name
Centre Mémoire de Ressources et de Recherche de Lyon
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak-Salmon, PhD
Phone
04 72 43 20 50
Email
pierre.krolak-salmon@chu-lyon.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Predictive Factors of Autonomy Loss in Real-life Cohort

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