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 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT06826261
Eligibility Criteria:
Inclusion Criteria:
* aged between 50 and 85.
* Clinical Dementia Rating score (CDR) of 0.5-1.
* Mini-Mental State Examination (MMSE) score of 18-26.
* treated with acetylcholinesterase inhibitor for at least one month.
* evidence of low β-amyloid and/or elevated phosphorylated Tau protein as detected by lumbar puncture for cerebrospinal fluid biomarkers analysis for diagnostic purposes or PET.
* have a Caregiver
* have access to wireless internet (wifi) connection in the location where study treatments will be applied
Exclusion Criteria:
* significant neurodegenerative disorder of the central nervous system other than AD.
* significant intracranial focal or vascular pathology verified by an MRI scan.
* history of seizures (except febrile seizures in childhood).
* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following (within the specified period): Major depressive disorder (current), Schizophrenia (lifetime), Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years).
* contraindications to MRI (this includes metal implants in the head, pacemaker, cochlear implants, or any other non-removable items if they are contraindications to MR imaging).
* treatment currently or within 3 months before Baseline with any of the following medications: typical and atypical antipsychotics (i.e., Clozapine, Olanzapine); antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin).
* skin lesions on the scalp at the proposed electrode sites.
* previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
* any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT06826261
Study Brief:
Protocol Section:
NCT06826261