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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06826157
Eligibility Criteria:
Inclusion criteria for all study subjects:
* right-handed participants;
* monolingual native Italian speakers;
* age between 50-85 years old;
* normal or corrected-to-normal visual acuity;
* oral and written informed consent to study participation.
* if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.
Inclusion criteria for MCI patients:
* diagnosis of amnestic MCI;
* mini Mental State Examination (MMSE) score ≥ 24;
* if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks;
* available CSF AD biomarkers.
Inclusion criteria for patients with mild dementia:
* diagnosis of AD dementia, FTD or LBD.
* MMSE score ≥ 15;
* if assuming anticholinesterase inhibitors (i.e., galantamine, rivastigmine, donepezil) or memantine, they should be at stable dosage for more than 4 weeks.
Exclusion criteria for patients:
* secondary forms of cognitive impairment on the basis of historical data, neurologic examination, and cerebral neuroimaging findings;
* very rapid cognitive decline that occurs over weeks or months, typically indicative of prion disease, neoplasm or metabolic disorders;
* history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
* alcohol and/or psychotropic drugs abuse;
* enrolment in clinical trials testing disease-modifying drugs for AD during study;
* contraindications to MRI study:
1. Cardiac pacemakers or other types of cardiac catheters;
2. metal splinters or fragments;
3. metal prostheses not compatible with the magnetic field generated during MRI;
4. claustrophobia.
* Women who are pregnant or intending to become pregnant during the study; breastfeeding women.
Exclusion criteria for healthy controls
* History of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic (including epilepsy), psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;
* alcohol and/or psychotropic drugs abuse;
* contraindications to MRI study (see above);
* women who are pregnant or intending to become pregnant during the study; breastfeeding women.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT06826157
Study Brief:
Protocol Section:
NCT06826157