NCT06826261 · ACTIVE NOT RECRUITING
Digital Twins for Model-driven Non-invasive Electrical Brain Stimulation
This pilot trial is testing whether daily at-home electrical brain stimulation, called transcranial alternating current stimulation or tACS, can slow cognitive decline in people with mild-to-moderate Alzheimer's disease. Researchers will use personalized, computer-modeled stimulation targeting brain wave activity in the prefrontal cortex over eight weeks. This is a Phase NA feasibility study, meaning the goal right now is mainly to check whether the approach is safe and practical before running a larger trial.
You may qualify if
- 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
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-13