Observational cohort of Alzheimer's patients and their families
Pilot Phase of a Prospective Cohort of Patients with Alzheimer's Disease and Their Families
This study looks at families with Alzheimer's patients to see how the disease affects them and their caregivers, while also trying to find factors that might help prevent dementia in relatives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 4 sites (France, Marseille and 3 other locations) |
| Trial ID | NCT05516667 on ClinicalTrials.gov |
What this trial studies
This pilot phase of a longitudinal observational cohort study focuses on family clusters that include Alzheimer's disease patients, their informal caregivers, and first-degree relatives. The study aims to follow these groups in expert memory centers and online to investigate risk and prognostic factors, including blood-based biomarkers, as well as the health and needs of caregivers. By studying first-degree relatives, who are at increased risk for dementia, the research seeks to identify modifiable risk factors and understand caregiver burden over time. This pilot will assess the feasibility of a larger-scale study.
Who should consider this trial
Good fit: Ideal candidates include patients with mild to moderate Alzheimer's disease, their caregivers, and first-degree relatives fluent in French.
Not a fit: Patients with severe Alzheimer's disease or those not fluent in French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the prevention and management of Alzheimer's disease and improve support for caregivers.
How similar studies have performed: While similar studies have explored Alzheimer's risk factors, this approach of integrating caregiver and familial perspectives in a longitudinal cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
o Inclusion criteria: AD patients: * Probable Alzheimer's disease (clinical and biological NINCDS-ADRDA 2011 criteria) * Mild-moderate AD (MMSE ≥15) * Sufficiently fluent in French in order to answer study questionnaires * Agrees to undergo medical examinations at baseline, 12 and 24 months, as outlined in the protocol * Affiliated to French social security * Written informed consent Caregivers: * Caregiver (defined as assisting the patient in activities of daily living for at least 6 hours per week during the last 6 months) to an AD patient having agreed to participate in the study * Age ≥18 years. * Sufficiently fluent in French in order to answer study questionnaires * Agrees to answer regular questionnaires about their own or the AD patient's health (during visits at study centres or via a secure internet website/postal questionnaires) * Affiliated to French social security * Written informed consent First-degree relatives: * First degree relative of an AD patient having agreed to participate in the study * Age ≥18 years. * Sufficiently fluent in French in order to answer study questionnaires * Agrees to undergo medical examinations at baseline, 12 and 24 months, as outlined in the protocol * Agrees to answer regular questionnaires about their own health (via a secure internet website or via postal questionnaires) * Affiliated to French social security * Written informed consent In order to be included in the study, a familial cluster must be comprised of 2 to 5 people, as follows: * Familial cluster of 2 people: 1 AD patient and 1 first-degree relative who also meets the caregiver inclusion criteria, OR * Familial cluster of 3 to 5 people: 1 AD patient, 1 caregiver (does not need to be a relative of the patient), 1 to 3 first-degree relatives of the patient * Exclusion criteria: AD patients: * Other brain disorders * Autosomal dominant form of AD * Under legal protection measure (guardianship, curators, safeguard of justice…) * Institutionalized * Life expectancy \<2 years Caregivers: * Under legal protection measure (guardianship, curators, safeguard of justice…) * Diagnosed with a major neurocognitive disorder First-degree relatives: * Related to a patient with an autosomal dominant form of dementia * Carrier of an autosomal dominant dementia mutation * Under legal protection measure (guardianship, curators, safeguard of justice…) * Diagnosed with a major neurocognitive disorder
Where this trial is running
France, Marseille and 3 other locations
- Hôpitaux Universitaires de Marseille Timone — France, Marseille, France (Recruiting)
- CMRR Centre de Montpellier — Montpellier, France (Recruiting)
- CMRR Centre de Rouen — Rouen, France (Recruiting)
- CMRR - CRC Centre de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Sandrine Andrieu, MD — University Hospital, Toulouse
- Study coordinator: Sandrine Andrieu, MD PhD
- Email: sandrine.andrieu@univ-tlse3.fr
- Phone: 05 61 14 59 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.