Cohort of Patients with Alzheimer's Disease and Their Families.
Recruiting · NCT05516667 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Hospital, Toulouse
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
4 locations listed.
- CMRR Centre de Montpellier - Montpellier, France
- CMRR Centre de Rouen - Rouen, France
- CMRR - CRC Centre de Toulouse - Toulouse, France
- Hôpitaux Universitaires de Marseille Timone - France, Marseille, France