RecruitingNCT05516667

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

Pilot Phase of a Prospective Cohort of Patients with Alzheimer's Disease and Their Families

Sponsor

University Hospital, Toulouse

Enrollment

1,000 participants

Start Date

Apr 6, 2023

Study Type

OBSERVATIONAL

Conditions

Alzheimer Disease

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

Min Age: 18 Years

Inclusion Criteria24

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 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