Non-Invasive Brain-Computer Interface with 40Hz Audio-Visual Stimulation to Improve Cognitive Function in Alzheimers Disease Patients Aged 50 to 80

What this Trial Is About

Researchers are evaluating a non-invasive brain-computer interface BCI combined with 40Hz audio-visual stimulation to study its effects on cognitive function in patients with Alzheimers disease AD. This randomized, double-blind, sham-controlled trial includes 90 participants diagnosed with AD confirmed by Ab2-PET scans according to NIA-AA criteria. The study aims to assess both safety and effectiveness of this neuromodulation technique. Participants are randomly assigned to one of three groups a fixed 40Hz stimulation group receiving daily 60-minute audio-visual stimulation for six months, an individualized stimulation group receiving similar stimulation adjusted in real-time via EEG feedback, and a sham stimulation group receiving inactive stimulation with low-intensity randomized flashes and sounds for the same duration. The trial compares the effects of fixed versus closed-loop stimulation and a control condition. Participants will undergo cognitive assessments including the Montreal Cognitive Assessment-Basic MoCA-B at baseline and after six months to measure changes in cognition. Additional tests, brain imaging MRI, fMRI, Ab2-PET, tau-PET, EEG monitoring, and blood biomarker analysis will be performed at baseline and follow-ups. Safety and tolerability are monitored throughout the six-month treatment period. The study duration and procedures offer detailed evaluation of cognitive outcomes and brain function in treated individuals.

BCI With 40Hz Stimulation in Alzheimer's Disease