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Clinical Trials in France / NCT03894254
Recruiting Not applicable

Predictive Factors of Autonomy Loss in Real-life Cohort

NCT03894254 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Not applicable
Started
2020-09-09
Last updated
2022-05-02

Condition(s) studied

Memory Disorders

Investigational drug(s) / intervention(s)

no intervention

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Functional autonomy level — from 6 months to 12 months interval
    The Lawton Instrumental Activities of Daily Living (IADL)
  • Functional autonomy level — from 6 months to 12 months interval
    The Disability Assessment of Dementia (DAD-6)
  • Functional autonomy level — from 6 months to 12 months interval
    The New-AGGIR (French national score for dependency assessment)

Trial sites (5)

FacilityCityRegionStatus
Hôpital Dugoujon Caluire-et-Cuire France Recruiting
Centre Hospitalier Lyon Sud Lyon France Recruiting
Service de neuro-cognition et neuro-ophtalmologie du Groupement Hospitalier Est Lyon France Recruiting
CHU Saint-Etienne Saint-Etienne France Recruiting
Centre Mémoire de Ressources et de Recherche de Lyon Villeurbanne France Recruiting

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Other trials for the same condition

Development, Standardisation and Standardisation Project for a New Memory Assessment Recruiting
Creation of an Ecological Tool Assessing Episodic Memory in Geriatrics Recruiting
Pilot Study on the Feasibility of Using Smartphone Data as a Diagnostic Marker for Alzheimer's Disease Active, not recruiting
Investigation of AlzHeimer's Predictors in Subjective Memory Complainers - Extension Study Recruiting
Optimization of MRI Sequences Used in the Study of Neurodegenerative Diseases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03894254 on ClinicalTrials.gov ↗ ← All trials in France