Aribio is accelerating the development of electronic medicine for dementia following its oral dementia drug.
On the 28th, Aribio announced that it received approval from the Ministry of Food and Drug Safety for a clinical trial plan (IDE) of a brain acoustic vibration electronic medicine targeting patients with Alzheimer's disease.
Unlike existing electronic medicines that utilized electric or electromagnetic fields and ultrasound methods, Aribio's brain acoustic vibration electronic medicine adopts an acoustic vibration approach. Through a miniature module, it generates specific wavelengths of sound and vibration that activate brain nerves and improve brain function, delivering them directly to the brain. This non-invasive brain stimulation is expected to slow the progression of Alzheimer's disease, reduce memory and cognitive decline, and improve patients' quality of life. Designed as a headband, it allows for gentle stimulation and can be used comfortably in daily life by elderly patients.
The clinical trial will be conducted with the neurology team led by Professor Kim Sang-yoon of Bundang Seoul National University Hospital, a leading expert in dementia in Korea, to verify the efficacy and safety of the brain acoustic vibration stimulation. The double-blind trial will involve 30 patients with early Alzheimer's disease, including mild cognitive impairment, over six months. The device's practical effects will be demonstrated through cognitive function assessments, magnetic resonance imaging (MRI) analysis, and blood biomarker analysis. Subsequently, an additional six-month open-label extension (OLE) trial will closely monitor participants' brain function improvements, aiming to establish a foundation for applying the treatment to a broader range of other degenerative brain disease patients in the future.
Professor Kim Sang-yoon expressed, "If the clinical trial is successfully completed, it could become one of the non-invasive and safe treatment options," adding, "It may serve as a catalyst for developing new treatments beyond the current drug-only limitations for Alzheimer's disease." Aribio CEO Jung Jae-joon stated, "If electronic medicine that all patients can safely and conveniently use is utilized alongside AR1001, an oral Alzheimer's drug currently undergoing global phase 3 clinical trials, it will create synergy in treatment."
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