Elderly (People Aged 65 or More)ICADNCT07409506
Assessment of Informal Support Provided by Caregivers at Different Stages of Alzheimer's Disease
An observational study of Elderly (People Aged 65 or More) and Neurocognition, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly (People Aged 65 or More), Neurocognition, Alzheimer s Disease
- What is being tested?
- " Ressources Utilisation in Dementia " (RUD) questionnaire.
- How many people
- 312 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to 9 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital des Charpennes
Villeurbanne, 69100
About this study
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.
- Being tested
- " Ressources Utilisation in Dementia " (RUD) questionnaire.
- Keywords
- informal care, cost of alzheimer's disease, caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
" Ressources Utilisation in Dementia " (RUD) questionnaire.Other
Questionnaire on the use of services available to patients with dementia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: " Ressources Utilisation in Dementia " (RUD) questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At inclusion or 15 days maximum after inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start9 Sep 2025
- Primary completion9 Sep 2026 (estimated)
- Study completion9 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly (People Aged 65 or More)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409506
- Sponsor's protocol ID
- 25-5152
- Other IDs
- 69HCL24_1258
- Acronym
- ICAD
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Informal Support Provided by Caregivers at Different Stages of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07409506
- Acronym / sponsor ID
- ICAD / 25-5152
- Keywords
- informal care, cost of alzheimer's disease, caregiver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 9 Sep 2026 (estimated)
- Study completion
- 9 Sep 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from Charpennes Hospital | – | Other: " Ressources Utilisation in Dementia " (RUD) questionnaire.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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- - 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)
- Patients or caregivers withdrawing their consent to participate during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| " Ressources Utilisation in Dementia " (RUD) questionnaire.Questionnaire on the use of services available to patients with dementia. | Other | Patients from Charpennes Hospital |
Primary outcome
Informal care costs
Time frame: At inclusion or 15 days maximum after inclusion.
Informal care will be collected according to the " Ressources Utilisation in Dementia " (RUD) questionnaire and valued in euros using replacement cost method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly (People Aged 65 or More) and Neurocognition, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GERVAIS F M Frédéric GERVAIS (0033 4 72 43 20 66, frederic.gervais02@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informal care costs (time frame: At inclusion or 15 days maximum after inclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.