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 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT05468268
Eligibility Criteria:
Inclusion Criteria:
* right-handed
* meet inclusion criteria related to TMS (attached in the protocol)
* to be able to provide information regarding their cognitive and functional skills, or have a caregiver available who is able to provide the patient information necessary for participation in the study and who is present when signing the patient's informed consent.
pAD Patient Inclusion Criteria:
* Clinical Dementia Rating Scale \<2;
* Diagnosis of prodromal Alzheimer's disease (amnesic MCI) according to the diagnostic criteria;
* Neurodegeneration biomarker for AD (FDG-PET or CSF), diagnosis confirmed by clinical follow-up;
* Montreal Cognitive Assessment (MoCA) test overall score within the normal limits (equivalent score of 1);
* Absence of severe vascular distress; Patients will be selected through clinical evaluation (battery of neuropsychological tests at the Neurocognitive Rehabilitation Center - CeRiN)
Exclusion Criteria:
* Patients who are unable to perform the tasks required by the experimental procedure;
* History and/or evidence of any other central nervous system disorder that could be interpreted as a cause of dementia such as structural or developmental abnormality, infectious epilepsy, degenerative or inflammatory/demyelinating diseases of the central nervous system such as Parkinson's disease;
* History of significant psychiatric disease which, in the investigator's judgment, could interfere with study participation.
* History of alcohol or other substance abuse, according to DSM-V criteria, if this could be a contributing factor to dementia;
* Presence of cardiac pacemakers, electronic prostheses, bio-stimulators, metal inserts, or electrodes implanted in the brain or skull, or spine;
* Inability to read and /or understand the written information;
* Dermatitis, eczema, extensive scars on the scalp
Absolute exclusion criteria (criteria for TMS)
* presence of cardiac pacemakers, artificial heart valves and/or bio- stimulators;
* presence of hearing aids located in the middle ear;
* presence of metal inserts on the head and shoulders;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT05468268
Study Brief:
Protocol Section:
NCT05468268