
Welcome to SaMD Lab!














SaMD Lab: Software as a Medical Device
At SaMD Lab, we are dedicated to leveraging technology to address the challenges of Alzheimer’s disease and mild cognitive disorders.
“Software as a Medical Device” (SaMD) represents our commitment to developing innovative,
AI-powered tools that serve as medical devices, aimed at improving the diagnosis, treatment, and management of cognitive impairments.
Our research is focused on enhancing the understanding of these conditions and advancing digital healthcare solutions.
Our research is driven by a passion for:
– Uncovering psychiatric conditions through brain imaging, bio-signals, and voice and facial analysis
– Advancing cognitive function evaluation with cutting-edge multimodal approaches, including brain imaging, facial expressions, voice, and fluid tests
– Harnessing artificial intelligence to diagnose dementia and enhance memory training through AI speakers and tablets
– Innovating AI-based digital healthcare systems and therapeutics, integrating real-time biofeedback analysis and intuitive, user-friendly interfaces
– Designing and experimenting with large language models (LLMs) to create automated medical systems for clinical decision support, patient interaction, and medical documentation
Research Topics
CogtheraAI
Developing personalized software that incorporates gamification and metamemory-based training to enhance cognitive function and support cognitive health.
VoxGnosis
The early diagnosis and subtype classification of Alzheimer’s disease based on digitalized speech signal
OldDigitalPlatform
Development and clinical application of digital therapeutic devices UX, untact clinical cloud platforms and RWE technologies based on the brain and body of the elderly
BloodBioMarker
Discovery of effective bacterial strains regulating the inflammatory response of microglia and identification of underlying mechanism through intestinal microbiome analysis of Alzheimer’s disease patients
Microbiota
Study of dementia specific Microbiome, lipidome and microRNA profile
OldDigitalPlatform
Development and clinical application of digital therapeutic devices UX, untact clinical cloud platforms and RWE technologies based on the brain and body of the elderly
Mediforum
To evaluate the safety and efficacy of PM012 tablets for Alzheimer’s disease, dose-finding study will be performed on phase 2b, and the established dose will be used for the non-inferiority phase 3 trial to evaluate the investigational product’s safety and efficacy: Double blind, randomized, active drug comparative, multi-center, parallel-group clinical trial
KBASE
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer’s disease (K-BASE)
KBASE2
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer’s disease 2 (K-BASE2)
ESCALADE
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With degenerative Mild Cognitive Impairment
BAN2401
A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease
E2609
A Placebo-Controlled, Double-Blind, Parallel-Group, 24-Month Study to Evaluate the Efficacy and Safety of E2609 in Subjects with Early Alzheimer’s Disease
KREATE
Korean Registry for Activating Trial on Dementia (KReAT-D)
Neurofolio
Post-market surveillance study of the Neurofolio
COVID-19
The Effects of COVID-19 Quarantine on the Cognitive and Behavioral Symptoms of Dementia
MRIRisk
대기오염과 알츠하이머병의 관계 규명 연구
EmoRobot
Developing mirroring expression based interactive robot technique by non-contact sensing and recognizing human intrinsic parameter for emotion healing through heart-body feedback
ARETE
20년 AI 음성 선별 모델 개발을 위한 음성기반 조기 치매선별 연구
FaceOff
Emotional recovery of patients with patients using facial emotional feedback program using camera
MCIExam
Standardization of neuropsychological test for dementia classification
DIGITAL BIOMARKER
Famenity
Verification of the Effects of Intervention Program on Improving Mental Health of patients with Post-traumatic Stress Disorder
CLINICAL TRIALS
Crenezumab-CREAD
A phase III, multicenter, randomized, double blind, placebo controlled, parallel group, efficacy and safety study of crenezumab in patients with prodromal to mild alzheimer’s disease