Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT05516667
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05516667
Study Brief:
Protocol Section:
NCT05516667