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.
Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can participate in the clinical trial without changing the dose during the trial period.
Male or female age 60-85 years.
Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.
Patients with central nervous system (CNS) disorders that may affect cognitive function (such as cerebrovascular diseases including vascular dementia, subdural hematoma, normal pressure hydrocephalus, brain tumors, CNS infections like HIV or syphilis, head trauma, Huntington's disease, Parkinson's disease, etc.) where cognitive decline may be explained by other causes, or in whom dementia types other than Alzheimer's disease are suspected.
Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.
History of Epileptic Seizures or Epilepsy.
Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.
Parallel
ATNC MDD-V1 (Real TMS + Real Cog)
DeviceSynchronized TMS and cognitive stimulation to 6 brain areas.
ATNC MDD-V1 (Sham TMS + Real Cog)
DeviceSham 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.
ATNC BN-V1
DeviceThe navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
ATNC BN-V2
DeviceThe navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
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
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
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
Clinical Dementia Rating(CDR)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating
Global Deterioration Scale(GDeps)(Efficacy)
Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale
Adverse events(AE's)(Safety)
Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up.
Click on the lead sponsor to view all of their trials.
Advanced Technology & Communications
Lead sponsor
Chungnam National University Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Dong-A University Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Chonbuk National University Hospital
Collaborator
Chung-Ang University Gwangmyeong Hospital
Collaborator
Yeungnam University Hospital
Collaborator
Inje University Ilsan Paik Hospital
Collaborator
National Health Insurance Service Ilsan Hospital
Collaborator
Konkuk University Medical Center
Collaborator
