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Clinical Trials in France / NCT05516667
Recruiting Observational

Cohort of Patients with Alzheimer's Disease and Their Families.

NCT05516667 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-04-06
Last updated
2024-12-19

Condition(s) studied

Alzheimer Disease

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Hôpitaux Universitaires de Marseille Timone France Marseille Recruiting
CMRR Centre de Montpellier Montpellier France Recruiting
CMRR Centre de Rouen Rouen France Recruiting
CMRR - CRC Centre de Toulouse Toulouse France Recruiting

More University Hospital, Toulouse trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05516667 on ClinicalTrials.gov ↗ ← All trials in France