Cohort of Patients With Alzheimer's Disease and Their Families. — ALFA3pilot  

Alzheimer Disease Clinical Trial

Official title: Pilot Phase of a Prospective Cohort of Patients With Alzheimer's Disease and Their Families

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alzheimer Disease

• NCT number: NCT05516667
• Study type: Observational
• Source: University Hospital, Toulouse
• Contact: Sandrine Andrieu, MD PhD
• Phone: 05 61 14 59 63
• Email: sandrine.andrieu@univ-tlse3.fr
• Status: Recruiting
• Start date: April 6, 2023
• Completion date: January 1, 2027