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Clinical Trials/NCT03894254
NCT03894254RecruitingNot 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 Lyon9 sites in 1 country5,400 target enrollmentStarted: September 9, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5,400
Locations
9
Primary Endpoint
Functional autonomy level

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Functional autonomy level

Time Frame: from 6 months to 12 months interval

The Lawton Instrumental Activities of Daily Living (IADL)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (9)

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