Predictive Factors of Autonomy Loss in Real-life Cohort
ConditionMemory Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients in institution
Patients under legal protection
Patients with a hearing or visual impairment, which prevents carrying out examinations
Trial design
Design model
Single group
Treatments tested in this trial
no intervention
Other interventionThis 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).
Treatment groups
5,400 Participants
are divided into 1 treatment groupGroup A: Patients with subjective cognitive complaint or neurocognitiveExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional autonomy level
The Lawton Instrumental Activities of Daily Living (IADL)
Time frame
from 6 months to 12 months interval2
Functional autonomy level
The Disability Assessment of Dementia (DAD-6)
Time frame
from 6 months to 12 months interval3
Functional autonomy level
The New-AGGIR (French national score for dependency assessment)
Time frame
from 6 months to 12 months intervalSponsors and contacts
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Source ClinicalTrials.gov