Cohort of Patients with Alzheimer's Disease and Their Families.

NCT ID: NCT05516667

Last Updated: 2024-12-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2027-01-01

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-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.

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 no curative treatment available, but the existence of a long preclinical period, during which biomarker changes are observed, and the identification of modifiable risk factors suggest that AD may be preventable. Data is currently lacking, however, on the trajectories and predictive value of blood-based biomarkers (which are more acceptable and less costly to measure than traditional imaging and Cerebrospinal fluid biomarkers biomarkers). Furthermore, although there has been much research into modifiable AD risk factors, they have often not been studied simultaneously in the same cohort, and there has been relatively little research into newly identified risk factors, such as hearing impairment. First-degree relatives of AD patients would seem an ideal population to study such factors, since they are at increased risk of dementia and cognitive decline, and may be more motivated to participate in dementia research studies than other individuals. Finally, although caregiver burden and quality of life have been previously studied, further data is required on their longitudinal trajectories, particularly taking into account the disease course of the patients they care for. Caregivers' needs and coping and caregiving strategies also need to be better understood. In the pilot phase of the ALFA3 study, 150 familial clusters (each comprised of a patient with Alzheimer's disease, a family caregiver and at least one first-degree relative of the patient) will be recruited and followed-up for 2 years in expert memory centers and via online questionnaires. This pilot phase will be used to study the feasibility of conducting a larger-scale study.

Conditions

Alzheimer Disease

Keywords

dementia; caregivers; risk factors; prognosis; first-degree relatives

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

France Alzheimer

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandrine Andrieu, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Hôpitaux Universitaires de Marseille Timone

France, Marseille, France

Site Status: RECRUITING

CMRR Centre de Montpellier

Montpellier, , France

Site Status: RECRUITING

CMRR Centre de Rouen

Rouen, , France

Site Status: RECRUITING

CMRR - CRC Centre de Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sandrine Andrieu, MD PhD

Role: CONTACT

Phone: 05 61 14 59 63

Email: sandrine.andrieu@univ-tlse3.fr

Nicola Coley, PhD

Role: CONTACT

Email: coley.n@chu-toulouse.fr

Facility Contacts

CECCALDI Mathieu

Role: primary

Karim BENNYS

Role: primary

DAVID WALLON

Role: primary

Pierre-Jean OUSSET

Role: primary

Other Identifiers

RC31/21/0575

Identifier Type: -

Identifier Source: org_study_id