The study tests the effect of the ATNC MDD-V1 on Alzheimer patients' cognitive function. The ATNC MDD-V1 uses non-invasive stimulation of both magnetic and cognitive training.
The ATNC MDD-V1 system is a combined system of Transcranial Magnetic Stimulation and cognitive training and is a non-invasive therapeutic system for the improvement of Alzheimer patients' cognitive function. A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment or sham (placebo) Patient will attend the clinic 5 times a week for 6 weeks, approximately an hour every day for treatment/sham. The patient will be required to return to the clinic for follow-up. Up to 180 patients will be enrolled in up to 11 clinical sites in the Republic Korea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Synchronized TMS and cognitive stimulation to 6 brain areas.
Sham device, has the same appearance and sound as the real device, combined with real cognitive exercises. Patients come for the same number of sessions, delivers no real stimulation or cognitive training.
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
Catholic university of Korea Incheon St. Mary's Hospital
Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, South Korea
RECRUITINGChung-Ang University Gwangmyeong Hospital
Gwangmyeong, Deokan-ro 110, South Korea
RECRUITINGjeonbuk National University Hospital
Jeonju, Deokjin-gu, South Korea
RECRUITINGChonnam National University Hopital
Gwangju, Dong-gu, South Korea
RECRUITINGYeungnam University Medical Center
Daegu, Hyeonchung-ro, Nam-gu, South Korea
RECRUITINGNational Health Insurance Service Ilsan Hospital
Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, South Korea
RECRUITINGInje University Ilsan Paik Hospital
Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si, South Korea
RECRUITINGChungnam National University Hospital
Daejeon, Jung-gu, South Korea
RECRUITINGKonkuk University Medical Center
Seoul, Neungdong-ro, Gwangjin-gu, South Korea
RECRUITINGDong-A University Hospital
Busan, Seo-gu, South Korea
RECRUITING...and 1 more locations
Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)
Change from Baseline to 24 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time frame: Week 24
Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)
Change from Baseline to 7,12 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time frame: Week 7, 12
Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in K-MMSE-2. K-MMSE-2: Korean-Mini Mental State Examination-2nd Edition
Time frame: Week 7, 12, 24
Clinical Dementia Rating(CDR)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating
Time frame: Week 7, 12, 24
Global Deterioration Scale(GDeps)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale
Time frame: Week 7, 12, 24
Clinical Global Impression of Change(CGIC)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in CGIC CGIC: Clinical Global Impression of Change
Time frame: Week 7, 12, 24
Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in K-IADL. K-IADL: Korean-Instrumental Activities of Daily Living
Time frame: Week 7, 12, 24
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