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 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT04421833
Eligibility Criteria:
Inclusion Criteria:
* Man or woman aged 60 to 106.
* Patient living in one of the USLD or UHR participating in the project.
* Score greater than or equal to 9 for at least one of the following items in the NPI-ES: apathy, agitation, anxiety, depression, aberrant motor behavior.
* Presence of TNC according to the standardization and calibration of the MMSE.
* The patients recruited must have given themselves, or through a trusted person provided for in article L. 1111-6 of the Public Health Code, failing this, by the family, or, failing that, by a person having close and stable ties with the person concerned; for adults under guardianship: the guardian or legal representative, for adults under guardianship: the curator, their informed consent to this study which must be approved by the Personal Protection Committee (PPC) prior to its completion.
Exclusion Criteria:
* Unstable pathology whose nature can interfere with the evaluation variables
* Deafness or blindness which could compromise the patient's assessment or his participation in the animation sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
106 Years
Study:
NCT04421833
Study Brief:
Protocol Section:
NCT04421833