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Recruiting NCT05516667

NCT05516667 Cohort of Patients with Alzheimer's Disease and Their Families.

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Clinical Trial Summary
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

Trial Parameters

Condition Alzheimer Disease
Sponsor University Hospital, Toulouse
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-06
Completion 2026-06-01

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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

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