NCT05516667 Cohort of Patients with Alzheimer's Disease and Their Families.
| NCT ID | NCT05516667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-04-06 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 1,000 participants in total. It began in 2023-04-06 with a primary completion date of 2026-06-01.
⚠ 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
This is the pilot phase of a longitudinal observational cohort study. The study includes family clusters comprised of a patient with Alzheimer's disease, an informal caregiver and at least one first-degree relative of the patient. The family clusters will be followed-up in expert memory centers and online in order to study risk and prognostic factors (including blood-based biomarkers) in the first-degree relatives and patients, respectively, as well as caregiver health, difficulties and needs. This pilot study is performed to assess the feasibility of conducting a larger-scale study.
Eligibility 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
Contact & Investigator
Sandrine Andrieu, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT05516667 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05516667 currently recruiting?
Yes, NCT05516667 is actively recruiting participants. Contact the research team at sandrine.andrieu@univ-tlse3.fr for enrollment information.
Where is the NCT05516667 trial being conducted?
This trial is being conducted at France, France, Montpellier, France, Rouen, France, Toulouse, France.
Who is sponsoring the NCT05516667 clinical trial?
NCT05516667 is sponsored by University Hospital, Toulouse. The principal investigator is Sandrine Andrieu, MD at University Hospital, Toulouse. The trial plans to enroll 1,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.