NCT07409506

Brief Summary

In France, approximately 1,200,000 people aged 65 and over suffer from Alzheimer's disease or related disorders, of which Alzheimer's disease (AD) accounts for 70% of cases. This prevalence could double by 2050. The cognitive decline and progression to functional dependence that accompany AD are associated with a decline in quality of life, an increased risk of comorbidities, institutionalization, and mortality, as well as high care costs, placing a burden on the patient, their family and friends, and the healthcare system. Informal care, i.e., care provided by a family member or caregiver, plays an important role in the overall management of major neurocognitive disorders (NCDs) associated with AD at home. In France, the annual cost of informal care for AD was estimated in 2008 at around €14 billion per year, or approximately 50% of the total annual cost of AD. The economic valuation of informal care serves to inform public decision-makers not only about the cost of this resource, but also about its usefulness. The issue of resource allocation (particularly the daily allowance for family caregivers - AJPA in French) at the societal level and the sharing of private (role of caregivers) and public (role of the state and local authorities) responsibilities leads us to question the determinants of this usefulness, particularly the clinical determinants in AD patients at different stages of the disease. The main hypothesis is that informal care varies according to cognitive decline and loss of autonomy, independently or in interaction with the number and type of the patient's comorbidities, their behavioral disorders, and the caregiver's burden.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Sep 2025Sep 2027

Study Start

First participant enrolled

September 9, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2027

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

December 16, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

informal carecost of alzheimer's diseasecaregiver

Outcome Measures

Primary Outcomes (1)

  • Informal care costs

    Informal care will be collected according to the " Ressources Utilisation in Dementia " (RUD) questionnaire and valued in euros using replacement cost method.

    At inclusion or 15 days maximum after inclusion.

Study Arms (1)

Patients from Charpennes Hospital

Patients from Charpennes Hospital included in the MEM-AURA cohort, accompanied by a caregiver and aged 60 years and older at inclusion with NCD due to clinically probable Alzheimer's disease and a Mini-Mental State Evaluation (MMSE) score ≤ 26 at inclusion.

Other: " Ressources Utilisation in Dementia " (RUD) questionnaire.

Interventions

Questionnaire on the use of services available to patients with dementia.

Patients from Charpennes Hospital

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients attending memory consultations at Charpennes Hospital (HCL) for cognitive complaints. Patients from Charpennes Hospital included in the MEM-AURA cohort, accompanied by a caregiver and aged 60 years and older at inclusion with NCD due to clinically probable Alzheimer's disease and a Mini-Mental State Evaluation (MMSE) score ≤ 26 at inclusion.

You may qualify if:

  • Patients from Charpennes Hospital included in the MEM-AURA cohort
  • Patients with dementia due to clinically probable Alzheimer's disease, regardless of stage

You may not qualify if:

  • \- Patients or caregivers who have expressed their opposition to the study
  • Patients living in institutions or nursing homes
  • Patients protected by law (under legal protection, guardianship, or conservatorship)
  • Early termination Criteria :
  • \- Patients or caregivers withdrawing their consent to participate during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Charpennes

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

GERVAIS F M Frédéric GERVAIS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2025

First Posted

February 13, 2026

Study Start

September 9, 2025

Primary Completion (Estimated)

September 9, 2026

Study Completion (Estimated)

September 9, 2027

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations