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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT04820127
Eligibility Criteria:
Inclusion Criteria:
For the patient :
* Diagnosed with major neuro-cognitive disorders (DSM V) at all severity stages.
* Leaving at home
* Assisted by a caregiver, from patient's family or personal environment, assuming most of patient care (spending at least 6 hours per week with the patient)
* caregiver available to come with the patient to study visits as planned per protocol
* existing agitation since at least one month (according to International Psychogeriatric Association (IPA) criteria)
* agitation severity ≥ 2 , based on Clinician Global Impression of Severity (CGI-S) (at least mild severity)
* the patient, his/her family member/trusted person , or his /her legal responsible has provided written informed consent to participate in the study
* referring physician's oral approval obtained for patient participation in the study
* Affiliated to French Healthcare System
For the caregiver:
* Has provided his/her written informed consent to participate in the study
* Ability to understand and speak French properly, ability to complete the questionnaires and assess the patient.
* Affiliated to French Healthcare System
Exclusion Criteria:
For the patient:
* Agitation symptoms attributable either to other concomitant prescriptions, or to other psychiatric or evolving somatic diseases.
* Patient living in a residential care facility or having an institutionalization project within 6 months
* Patient with clinically significant or unstable disease that could affect he/her ability to come for the study visit or complete the evaluations planned as per protocol
* Concomitant participation to any other interventional research study
* Patient under legal protection.
For the caregiver:
* Caregiver under legal protection.
* Limited internet access or caregiver feeling unable to use it
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04820127
Study Brief:
Protocol Section:
NCT04820127