Ybrain Receives IND Approval for Confirmatory Clinical Trial of Electronic Medicine for Mild Cognitive Impairment

Ybrain, a mental health digital therapeutics platform company, announced on the 14th that it has received approval for an Investigational New Drug (IND) application from the Ministry of Food and Drug Safety (MFDS) for a confirmatory clinical trial of a transcranial direct current stimulator for patients with mild cognitive impairment (MCI). This is the first time the MFDS has approved a confirmatory clinical trial for MCI using electrical stimulation.

This clinical trial targets patients with Alzheimer's-type MCI who are undergoing drug treatment. The purpose is to evaluate the efficacy and safety of temporary cognitive improvement using the transcranial direct current stimulator (YMS-201B+). The trial will be conducted as a multicenter, randomized, double-blind, sham stimulation-controlled, sponsor-initiated clinical study. The participating clinical institutions include Incheon St. Mary's Hospital of The Catholic University of Korea College of Medicine, Soonchunhyang Cheonan Hospital of Soonchunhyang University College of Medicine, and Anam Hospital of Korea University College of Medicine.

MCI refers to a condition where cognitive functions such as memory and language ability are impaired compared to normal individuals of the same age, education level, and gender, although it cannot yet be classified as dementia. According to a report by the Korean Dementia Association last year, the number of MCI patients in South Korea is approximately 2.54 million. Additionally, 10-15% of patients diagnosed with MCI progress to dementia each year, placing them in a high-risk pre-dementia stage. Therefore, MCI is considered the earliest stage detectable through hospital examinations and is clinically very important as it allows for maximizing treatment effectiveness.

Professor Yang Young-soon of Soonchunhyang University College of Medicine stated, “Although the importance of early detection and treatment of MCI related to dementia has recently emerged, there are still few treatments available for MCI. It is very good news for patients that Ybrain can now begin confirmatory clinical trials for MCI digital therapeutics.” Lee Ki-won, CEO of Ybrain, also expressed gratitude to the MFDS for enabling the start of confirmatory clinical trials for Ybrain’s prescription digital therapeutics new treatment line, saying, “Since MCI is a dangerous condition that can lead to dementia, we will prove its efficacy and safety through clinical trials and bring good news to the treatment market.”

This content was produced with the assistance of AI translation services.