Predictive Factors of Autonomy Loss in Real-life Cohort

Not Applicable

Recruiting

• Conditions: Memory Disorders
• Interventions: Other: no intervention

• Registration Number: NCT03894254
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Study Start: 2020-09-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-05-02
• Primary Completion: 2024-03-01
• Study Completion: 2032-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5400

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with subjective cognitive complaint or neurocognitive	no intervention	: 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

Primary Outcome Measures

Name	Time	Method
Functional autonomy level	from 6 months to 12 months interval	The New-AGGIR (French national score for dependency assessment)

Trial Locations

Locations (5)

Centre Hospitalier Lyon Sud; 🇫🇷 Lyon, France

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France

Centre Mémoire de Ressources et de Recherche de Lyon; 🇫🇷 Villeurbanne, France

Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est; 🇫🇷 Lyon, France

Hôpital Dugoujon; 🇫🇷 Caluire-et-Cuire, France