💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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