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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT02208193
Eligibility Criteria:
Inclusion Criteria:
* aged 60 to 100 years
* able to walk independently, that is to say without recourse to aid, whether human or technical, except for a simple cane
* have never been in the garden " art, memory and life " of the Paul Spillmann Centre
* gave their written consent after receiving clear and intelligible written and oral information
* with a diagnosis of a probable mild to severe stage of Alzheimer's disease according to NINCDS-ADRDA diagnostic criteria (McKhann et al., 1984) within the last 2 months prior to inclusion
* score less than or equal to 4 on the Hachinski Ischemic Scale (Hachinski et al., 1984) within the last 2 months prior to inclusion
* Folstein MMSE score between 7 and 24 inclusively within the last 2 months prior to inclusion
* score of 4, 5 or 6 on the Reisberg Global Deterioration Scale (Reisberg et al., 1982) within a 2-month delay prior to inclusion
* specific drug treatment for Alzheimer's disease, unchanged since at least 2 months (cholinesterase inhibitor and memantine)
* no change in psychotropic treatment within 48 hours prior to inclusion
Exclusion Criteria:
* lack of insurance coverage
* sensory deficit interfering with the designated tasks in the study
* phasic disorders interfering with the designated tasks in the study
* history of head trauma (with loss of consciousness)
* chronic alcoholism
* refusal or inability to obtain the informed written consent of the subject
* persons subject to a legal protection order
* severe depression: score \> 20 on the GDS (Geriatric Depression Scale) scale at inclusion
* other neurological or psychiatric disorders potentially affecting the assessment
* current or planned participation to other research involving neuropsychological evaluations and/or drug trial, up until the end of the current study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02208193
Study Brief:
Protocol Section:
NCT02208193