Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-85
SponsorAdvanced Technology & Communications

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • ATNC MDD-V1 (Real TMS + Real Cog)
  • ATNC MDD-V1 (Sham TMS + Real Cog)
  • ATNC BN-V1
  • ATNC BN-V2

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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