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)
Recruitment rate — 18-months after the first inclusion rate of actual inclusion on anticipated inclusion 9 months and 18-months after the first inclusion. Expressed in percentage
Retention rate — 24 months after the first inclusion rate of remaining participants on actual inclusions 24 months after the first subject was included. Expressed in percentage
Trial sites (4)
Facility
City
Region
Status
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
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.
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