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Clinical Trials/NCT03894254
NCT03894254
Recruiting
Not Applicable

Predictive Factors Associated With Impairment in Functional Autonomy in a Regional Real-life Cohort of Patients With Alzheimer's Disease or Related Disorders (ADRD)

Hospices Civils de Lyon5 sites in 1 country5,400 target enrollmentSeptember 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Memory Disorders
Sponsor
Hospices Civils de Lyon
Enrollment
5400
Locations
5
Primary Endpoint
Functional autonomy level
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2020
End Date
March 1, 2032
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Functional autonomy level

Time Frame: from 6 months to 12 months interval

The New-AGGIR (French national score for dependency assessment)

Study Sites (5)

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