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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04493957
Eligibility Criteria:
Inclusion Criteria:
* aged between 50 and 95 years-old
* hold a driving license,
* drive at least twice a week,
* to have given free and informed consent,
* present a diagnosis of major or minor CNS according to DSM V, whose clinically probable or definite etiology is Alzheimer's or related or vascular disease,
* have a result in the Mini Mental State Examination (MMSE) greater than 18,
* have the ability to speak orally enough or write enough to perform clinical evaluations and workshops, be accompanied by a family member present at least 4 hours a week.
Criteria for inclusion of carers:
* to be a caregiver helping the patient for activities of daily living,
* to have given their free and informed consent,
* have the ability to speak orally and write enough to perform clinical assessments.
Exclusion Criteria:
* have a major psychiatric history, history of alcoholism, anti-depressant
* have sensory problems preventing participation in workshops,
* be affected by any debilitating pathology compromising the health of the patient in the short and medium term,
* be unable to express consent. Criteria for non-inclusion of caregivers: have sensory disturbances preventing participation in workshops.
Recruited patients and caregivers should have been informed and signed a consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
95 Years
Study:
NCT04493957
Study Brief:
Protocol Section:
NCT04493957