Status:
RECRUITING
Cohort of Patients with Alzheimer's Disease and Their Families.
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
France Alzheimer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
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-d...
Detailed Description
Alzheimer's disease (AD) is a progressive neurodegenerative disease and the primary cause of dementia. It brings about a huge burden for patients, families and society as a whole. There is currently n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05516667
Start Date
April 6 2023
End Date
January 1 2027
Last Update
December 19 2024
Active Locations (4)
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1
Hôpitaux Universitaires de Marseille Timone
France, Marseille, France, 13005
2
CMRR Centre de Montpellier
Montpellier, France
3
CMRR Centre de Rouen
Rouen, France
4
CMRR - CRC Centre de Toulouse
Toulouse, France