NCT07409506 Assessment of Informal Support Provided by Caregivers at Different Stages of Alzheimer's Disease
| NCT ID | NCT07409506 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Elderly (People Aged 65 or More) |
| Study Type | OBSERVATIONAL |
| Enrollment | 312 participants |
| Start Date | 2025-09-09 |
| Primary Completion | 2026-09-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 312 participants in total. It began in 2025-09-09 with a primary completion date of 2026-09-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients from Charpennes Hospital included in the MEM-AURA cohort * Patients aged 60 years and older at inclusion * Patients with dementia due to clinically probable Alzheimer's disease, regardless of stage * Patients with a Mini-Mental State Evaluation (MMSE) score ≤ 26 at inclusion * Patients accompanied by a caregiver at inclusion Exclusion Criteria: * \- 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 & Investigator
Frequently Asked Questions
Who can join the NCT07409506 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Elderly (People Aged 65 or More). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07409506 currently recruiting?
Yes, NCT07409506 is actively recruiting participants. Contact the research team at frederic.gervais02@chu-lyon.fr for enrollment information.
Where is the NCT07409506 trial being conducted?
This trial is being conducted at Villeurbanne, France.
Who is sponsoring the NCT07409506 clinical trial?
NCT07409506 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 312 participants.