Predictive Factors of Autonomy Loss in Real-life Cohort

Memory Disorders Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894254
• Other study ID #: 69HCL18_0613
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: March 1, 2032

Study information

• Verified date: April 2022
• Source: Hospices Civils de Lyon
• Contact: Pierre Krolak-Salmon, PhD
• Phone: 04 72 43 20 50
• Email: pierre.krolak-salmon[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: March 1, 2032
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Memory Disorders

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Dugoujon	Caluire-et-Cuire
France	Centre Hospitalier Lyon Sud	Lyon
France	Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est	Lyon
France	CHU Saint-Etienne	Saint-Étienne
France	Centre Mémoire de Ressources et de Recherche de Lyon	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional autonomy level	The Lawton Instrumental Activities of Daily Living (IADL)	from 6 months to 12 months interval
Primary	Functional autonomy level	The Disability Assessment of Dementia (DAD-6)	from 6 months to 12 months interval
Primary	Functional autonomy level	The New-AGGIR (French national score for dependency assessment)	from 6 months to 12 months interval