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:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06278818
Eligibility Criteria:
Inclusion criteria for MCI-AD subjects:
* Confirmed clinical diagnosis of MCI due to possible Alzheimer\'s disease with evidence of AD pathophysiological processes, according to National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association criteria (Albert et al., 2011);
* Ability to understand and consciously sign informed consent and adhere to study procedures.
* Educational level ≥ 5 years.
Inclusion criteria for MCI-PD subjects:
* Clinical diagnosis of MCI-PD according to Level II criteria (Litvan et al., 2012). Ability to understand and consciously sign informed consent and adhere to study procedures.
* Educational level ≥ 5 years.
Exclusion criteria:
* Aphasia, visuospatial neglect;
* Atypical and/or secondary parkinsonisms;
* Dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria;
* Alterations of consciousness;
* Sensory disorders that could interfere with the execution of tests and rehabilitative treatment;
* Concurrent psychiatric and/or neurological and/or essential tremor disorders;
* Presence of systemic inflammatory and infectious diseases, autoimmune diseases, malignant tumors at the time of recruitment, deemed clinically significant by the investigator and therefore capable of interfering with the study results;
* Inability or unwillingness to undergo MRI and/or EEG;
* Presence of prostheses or metallic implants incompatible with MRI;
* Deep brain stimulation (DBS) implant.
* Any dropouts will be managed by enrolling new patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT06278818
Study Brief:
Protocol Section:
NCT06278818