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 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06213766
Eligibility Criteria:
Inclusion Criteria:
Cognitively healthy subjects:
* Participants aged between 20 and 85 years old;
* Participant affiliated or entitled to a social security scheme;
* Participants who have been informed and have given written consent.
Patients with Alzheimer's disease:
* Participant aged between 50 to 85 years old;
* Participant undergoing memory clinic consultations for a diagnosed Alzheimer's disease, at the stage of minor neurocognitive impairment or major neurocognitive impairment, according to the NIA-AA 2011 criteria (McKahn et al., 2011, Albert et al., 2011);
* Mild to moderate cognitive impairment, Mini-Mental State Examination (MMSE ≥ 20/30, in the 6 months prior to inclusion);
* Participant affiliated or entitled to a social security scheme;
* Participants who have been informed and have given written consent.
Exclusion Criteria:
For all participants:
* Severe, progressive or unstable pathology whose nature may interfere with the assessment variables (epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection);
* Consumption of toxic substances that may affect cognitive performance;
* Deafness or blindness that could compromise the participant's assessment or participation in tasks and scales;
* Participants under guardianship or legal protection;
* Pregnant women, women in labour or breastfeeding mothers;
* Persons under psychiatric care.
Cognitively healthy subjects:
\- Participants diagnosed with a cognitive disorder.
Specifically for patients with Alzheimer's disease:
* Participants with a diagnosis other than Alzheimer's disease that promotes neurocognitive impairment (with the exception of cerebral microvascular involvement, i.e. mild to moderate microangiopathy);
* Severe cerebral microangiopathy (extensive and severe white matter hypersignals, Fazekas score = 3);
* Severe psycho-behavioral manifestations preventing performance of the task, at the investigator's discretion;
* Current participation in an Alzheimer's disease drug research protocol, in particular testing 'disease-modifying' treatments that may interact with the pathophysiology of the disease (after randomisation).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT06213766
Study Brief:
Protocol Section:
NCT06213766