NCT05516667Recruiting
Cohort of Patients with Alzheimer's Disease and Their Families.
Pilot Phase of a Prospective Cohort of Patients with Alzheimer's Disease and Their Families
Source: ClinicalTrials.gov · Last updated 19 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 6 Apr 2023
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Alzheimer disease
- NCT number
- NCT05516667
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 6 Apr 2023 to the primary completion date, 1 Jun 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpitaux Universitaires de Marseille Timone Coordinator of this site? Confirm its status | France | France | Recruiting |
| CMRR Centre de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CMRR Centre de Rouen Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| CMRR - CRC Centre de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.