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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT03052712
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form (ICF)
2. Male or female, aged 20 to 80 years inclusive at the time of signing ICF
3. French-speaking
4. reliable informant
Controls:
5. derived from the general population and consenting to participate in the study
Patients:
6. MMS\>18
7. Patients followed for mild or major neurocognitive disorder related to :
* Alzheimer's disease
* Frontotemporal lobar degeneration
* Lewy bodies disease
* Parkinson's disease
* Huntington's disease
* Progressive supranuclear palsy
* traumatic brain injury
* stroke or cerebral anoxia
* mixed diseases
* focal cerebral diseases
Exclusion Criteria:
1. Illiteracy
2. mental retardation
3. visual or motor deficit preventing reading, drawing or writing (scores on the reading, drawing or sentence writing subtests of the MMSE = 0)
4. hearing impairment interfering with understanding of instructions,
5. history of brain disease, including head injury with loss of consciousness lasting \> 15 minutes, stroke, coma or loss of consciousness lasting \> 15 minutes, followed for sclerosis or other brain disease, brain radiation therapy, epilepsy currently requiring treatment
6. history of psychiatric illness (schizophrenia or other psychosis) or ongoing psychiatric illness (major depressive disorder or other condition) currently requiring treatment or requiring a stay \> 2 days in a psychiatry unit or anxiety requiring more than one medication at the present time
7. alcoholism (mean alcohol consumption \> 3 standard drinks/day or history of alcohol withdrawal)
8. use of opiates or other illicit drugs during the previous 3 months or causing withdrawal syndrome
9. ongoing antidepressant or antiepileptic treatment
10. anxiolytic or hypnotic treatment initiated or increased during the previous month
11. general anaesthesia during the previous 3 months
12. history of heart surgery with cardiopulmonary bypass
13. comorbidities affecting cognition (respiratory, renal, liver, heart failure…)
14. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile)
15. persons placed under judicial protection
Patients :
16. contraindication to MRI
Controls:
17. deficit on MMSE \<27
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT03052712
Study Brief:
Protocol Section:
NCT03052712