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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT04570761
Eligibility Criteria:
Inclusion Criteria common to all participants:
* Age\> 50 years at the inclusion
* Patient with regular sleep patterns
* Patient having given written consent
* Patient affiliated to a social security regimen
Inclusion criteria for subjects with Alzheimer's disease:
* Patient with a beginning Alzheimer's disease defined according to the criteria of the National Institute on Aging-Alzheimer's Association or carriers of a prodromal Alzheimer's disease defined according to the criteria of the International Working Group IWG-2; the diagnosis must be supported by brain imaging and a blood test carried out in routine care
* MMSE score ≥ 24
Inclusion criteria for healthy volunteers:
* Absence of neurodegenerative pathologies
* Matched in age (+/- 5 years) and in sex with a patient
Non-inclusion criteria common to all participants:
* Psychiatric pathologies (except depression or anxiety disorders stabilized for more than 3 months)
* History of pathology which may have consequences on cognitive functioning and / or sleep: brain tumor, constituted stroke, epilepsy, head trauma (with clinical or parenchymal sequelae objectified on brain imagery), brain surgery
* Any significant comorbidity likely to constitute a confounding factor according to the clinician
* Psychotropic treatments introduced or modified \<3 months before inclusion
* Hypnotic and / or sedative treatments
* Chronic consumption of alcohol or drugs
* Legal incapacity and / or other circumstance rendering the patient unable to understand the nature, objective or consequences of the study
* Major under guardianship or curatorship
* Patient not French-speaking by birth or illiterate
Exclusion Criteria common to all participants:
* Sleep disorders defined by a score\> 5 on the Pittsburg sleep quality index (PSQI)
* A score\> 10 on the Epworth sleepiness index
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04570761
Study Brief:
Protocol Section:
NCT04570761