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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
France
Hôpitaux Universitaires de Marseille Timone
RECRUITING
France
CMRR Centre de Montpellier
RECRUITING
Montpellier
CMRR Centre de Rouen
RECRUITING
Rouen
CMRR - CRC Centre de Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Sandrine Andrieu, MD PhD
sandrine.andrieu@univ-tlse3.fr
05 61 14 59 63
Backup
Nicola Coley, PhD
coley.n@chu-toulouse.fr
Time Frame
Start Date: 2023-04-06
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 1000
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse
Collaborators: France Alzheimer

This content was sourced from clinicaltrials.gov