Observational cohort of Alzheimer's patients and their families

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot phase of a longitudinal observational cohort study focuses on family clusters that include Alzheimer's disease patients, their informal caregivers, and first-degree relatives. The study aims to follow these groups in expert memory centers and online to investigate risk and prognostic factors, including blood-based biomarkers, as well as the health and needs of caregivers. By studying first-degree relatives, who are at increased risk for dementia, the research seeks to identify modifiable risk factors and understand caregiver burden over time. This pilot will assess the feasibility of a larger-scale study.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Hôpitaux Universitaires de Marseille Timone
  France, Marseille, France Recruiting
• CMRR Centre de Montpellier
  Montpellier, France Recruiting
• CMRR Centre de Rouen
  Rouen, France Recruiting
• CMRR - CRC Centre de Toulouse
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Sandrine Andrieu, MD — University Hospital, Toulouse
• Study coordinator: Sandrine Andrieu, MD PhD
• Email: sandrine.andrieu@univ-tlse3.fr
• Phone: 05 61 14 59 63

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.