Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03894254

Predictive Factors of Autonomy Loss in Real-life Cohort

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Dugoujon, Caluire-et-Cuire, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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).

Primary outcomes

  1. Functional autonomy level

    Time frame: from 6 months to 12 months interval

    The Lawton Instrumental Activities of Daily Living (IADL)

  2. Functional autonomy level

    Time frame: from 6 months to 12 months interval

    The Disability Assessment of Dementia (DAD-6)

  3. Functional autonomy level

    Time frame: from 6 months to 12 months interval

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

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre Krolak-Salmon, PhD

CONTACT

[email protected]

04 72 43 20 50

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MEM-AURA

Important dates

Study start
2020
Primary completion
2024
Study completion
2032
First posted
Mar 28, 2019
Registry last updated
May 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.