Cohort of Patients with Alzheimer's Disease and Their Families.
- Conditions
- Alzheimer Disease
- Registration Number
- NCT05516667
- Lead Sponsor
- University Hospital, Toulouse
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recruitment rate 18-months after the first inclusion rate of actual inclusion on anticipated inclusion 9 months and 18-months after the first inclusion. Expressed in percentage
Retention rate 24 months after the first inclusion rate of remaining participants on actual inclusions 24 months after the first subject was included. Expressed in percentage
- Secondary Outcome Measures
Name Time Method Cognitive function 60 months after Baseline Evolution of the Mini Mental State Examination score : from Baseline to the end of follow-up.
The scores can vary from 0 to 30; 0 being the lowest cognitive function and 30 representing "non pathological" functioning.
Trial Locations
- Locations (4)
Hôpitaux Universitaires de Marseille Timone
🇫🇷France, Marseille, France
CMRR Centre de Montpellier
🇫🇷Montpellier, France
CMRR Centre de Rouen
🇫🇷Rouen, France
CMRR - CRC Centre de Toulouse
🇫🇷Toulouse, France