Condition: Alzheimer Dementia (AD) · Sponsor: Ruijin Hospital
This study aims to evaluate the efficacy and safety of non-invasive brain-computer interface (BCI) neuromodulation technique combined with 40Hz audio-visual stimulation on cognitive function in patients with Alzheimer's disease (AD). This is a single-center, randomized, double-blind, sham-controlled trial. A total of 90 participants with Aβ-PET positive AD diagnosed according to NIA-AA criteria will be enrolled and randomly assigned to three groups in a 1:1:1 ratio: (1) 40Hz stimulation group (fixed 40Hz audio-visual stimulation, 60 minutes daily for 6 months), (2) individualized stimulation group (closed-loop BCI with real-time EEG feedback to adjust stimulation parameters, 60 minutes daily for 6 months), and (3) sham stimulation group (inactive stimulation, same duration). The primary outcome is the change in MoCA-B score from baseline to 6 months. Secondary outcomes include changes in cognitive domain-specific assessments (AVLT, STT, DST), multimodal brain imaging, EEG parameters, peripheral blood AD biomarkers, safety, tolerability, and comparison of efficacy between open-loop and closed-loop stimulation.
This description comes directly from the study's public registry record.
Chao Gao · +8618217590273 · anshangaochao@163.com
Binyin Li, MD，Ph.D · +8613681884221 · libinyin@126.com
Always discuss trial participation with your own doctor first.
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07618481