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RecruitingNCT06088121ATC-P001Updated Apr 23, 2026

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

An interventional study of ATNC MDD-V1 (Real TMS + Real Cog) and ATNC MDD-V1 (Sham TMS + Real Cog) in Alzheimer's Disease, Dementia and Brain Diseases, sponsored by Advanced Technology & Communications. Recruiting at 11 sites in South Korea. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Advanced Technology & Communications · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2023, registered Sep 2023).
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Alzheimer's Disease
  • Dementia
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Neurodegenerative Diseases
  • Neurocognitive Disorders
  • Mental Disorder

Keywords

  • TMS
  • Cognitive Stimulation
  • ATNC MDD-V1
  • Dementia
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 180 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

This is the only study on the registry with Advanced Technology & Communications as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Male or female age 60-85 years.
  3. Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
  4. A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.
  5. MMSE score 21 to 26.
  6. CDR 1 or GDS 3.

    ※ For subjects who are excluded from screening based on criteria 5 or 6, if the investigator judges that the subject is likely to be eligible, one repeat screening may be performed.

  7. A patient who is deemed physically eligible for the clinical trial based on medical records and physical examination.
  8. A patient who is unable to provide voluntary informed consent for the clinical trial due to impaired decision-making capacity, for whom a legally authorized representative provides consent for participation, and who can attend follow-up visits with a caregiver.
  9. Patients who agreed to participate in all 24-week clinical trials.
  10. Patients with normal ability to see and hear letters.
  11. Patients who speak Korean as their mother tongue

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic examination.
  3. History of Epileptic Seizures or Epilepsy.
  4. Patients with a history of drug abuse, including alcohol, in the past 5 years from the time of screening.
  5. Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress, severe anxiety, mental retardation, DSM-V disorder.
  6. Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator to affect or are caused by the severity of dementia.
  7. Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.
  8. Cardiac pacemakers.
  9. Implanted medication pumps.
  10. Intracardiac lines.
  11. Patients who are currently taking medications that lower the convulsive seizure threshold.
  12. Significant heart disease.
  13. Patients with severe renal or hepatic impairment※, referring to conditions that significantly affect daily living (e.g., stage 4 chronic kidney disease), with the assessment based on the investigator's judgment.
  14. Contraindication for performing MRI scanning.
  15. Contraindication for performing amyloid PET-CT scanning.
  16. Patients who do not consent to TMS treatment and participation in this clinical trial.
  17. Patients who participated in other clinical trials 3 months before participating in this clinical trial.

    ※ Subjects who participate in non-interventional studies (such as observational studies) that do not affect the subject's disease or symptoms may be enrolled in the study.

  18. Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial.
  19. Patients judged by the investigator to be unsuitable for participation in clinical trials for other reasons.

    ※ If the test subject is unable to visit according to the research plan due to unavoidable personal circumstances during the screening period, it will be treated as a screening dropout, and the patient can participate in the study after re-agreeing according to the future schedule.

  20. Patients with a history of malignant tumors within the last 5 years.

    - Participation is possible if more than 5 years have elapsed without recurrence after the decision to be cured (The point of complete removal of the tumor through surgery or the end of chemotherapy, etc.).

  21. Patients who need to take medications suggested in concomitantly contraindicated drugs.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    ATNC MDD-V1

    ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation

    Device: ATNC MDD-V1 (Real TMS + Real Cog) · Device: ATNC BN-V1 · Device: ATNC BN-V2

  • Sham comparator
    Sham TMS + Real Cog

    The Control arm subjects will receive daily treatments five days a week for 6 consecutive weeks of Sham treatment of TMS and real cognitive training which is similar to the real treatment in visit frequency and procedure.

    Device: ATNC MDD-V1 (Sham TMS + Real Cog) · Device: ATNC BN-V1 · Device: ATNC BN-V2

Interventions

  • DeviceATNC MDD-V1 (Real TMS + Real Cog)

    Synchronized TMS and cognitive stimulation to 6 brain areas.

    Also known as: ATNC MDD-V1, Brain Sense & Brain Cog

  • DeviceATNC MDD-V1 (Sham TMS + Real Cog)

    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.

    Also known as: sham

  • DeviceATNC BN-V1

    The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).

    Also known as: Brain Navigation System V1

  • DeviceATNC BN-V2

    The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).

    Also known as: Brain Navigation System V2

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. Adverse events(AE's)(Safety)

    Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up.

    Time frame: Week 24

07

Study locations

11 of 11 sites recruiting
  • Catholic university of Korea Incheon St. Mary's Hospital
    Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu 403-720, South Korea
    • AT&C · Contact · jinwoo.shin@atnci.com · +82-31-445-1565
    • Inwook MD Song, Ph.D · Principal investigator
    Recruiting
  • Chung-Ang University Gwangmyeong Hospital
    Gwangmyeong, Deokan-ro 110 14353, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Mincheol MD Park, Ph.D · Principal investigator
    Recruiting
  • jeonbuk National University Hospital
    Jeonju, Deokjin-gu 54907, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Su-Hyun MD Jo, Ph.D · Principal investigator
    Recruiting
  • Chonnam National University Hopital
    Gwangju, Dong-gu 61469, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Goun MD Kim, Ph.D · Principal investigator
    Recruiting
  • Yeungnam University Medical Center
    Daegu, Hyeonchung-ro, Nam-gu 42415, South Korea
    • AT&C · Contact · jinwoo.shin@atnci.com · +82-31-445-1565
    • Miyoung MD Park, Ph.D · Principal investigator
    Recruiting
  • National Health Insurance Service Ilsan Hospital
    Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si 10444, South Korea
    Recruiting
  • Inje University Ilsan Paik Hospital
    Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si 10380, South Korea
    • AT&C · Contact · jinwoo.shin@atnci.com · +82-31-445-1565
    • Younggeon MD Lee, Ph.D · Principal investigator
    Recruiting
  • Chungnam National University Hospital
    Daejeon, Jung-gu 35015, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Ae Young MD LEE, PhD · Principal investigator
    Recruiting
  • Konkuk University Medical Center
    Seoul, Neungdong-ro, Gwangjin-gu 05030, South Korea
    • AT&C · Contact · jinwoo.shin@atnci.com · +82-31-445-1565
    • Yeonsil MD Moon, PhD · Principal investigator
    Recruiting
  • Dong-A University Hospital
    Busan, Seo-gu 49315, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Kyung Won MD Park, PhD · Principal investigator
    Recruiting
  • Korea University Anam Hospital
    Seoul, Seongbuk-gu 02841, South Korea
    • AT&C · Contact · hyunah.lee@atnci.com · +82-31-445-1565
    • Kun Woo MD Park, PhD · Principal investigator
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06088121
Lead sponsor
Advanced Technology & Communications
Collaborators
Chungnam National University Hospital, Korea University Anam Hospital, Dong-A University Hospital, Chonnam National University Hospital, Chonbuk National University Hospital, Chung-Ang University Gwangmyeong Hospital, Yeungnam University Hospital, Inje University Ilsan Paik Hospital, National Health Insurance Service Ilsan Hospital, Konkuk University Medical Center
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
May 15, 2023
Primary completion
Jan 15, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Shin Jinwoo
Contact
jinwoo.shin@atnci.com
+82314450566
Hyunah Lee
Contact
hyunah.lee@atnci.com
+821079373566
Ae Young MD LEE, PhD
principal investigator · Chungnam National University Hospital
Kun Woo MD Park, PhD
principal investigator · Korea University Anam Hospital
Deye MD Yoon, PhD
principal investigator · Dong-A University Hospital
Goun MD Kim, PhD
principal investigator · Chonbuk National University Hospital
Su-Hyun MD Jo, PhD
principal investigator · Chonnam National University Hospital
Mincheol MD Park, PhD
principal investigator · Chung-Ang University Gwangmyeong Hospital
Inwook MD Song, PhD
principal investigator · Incheon St.Mary's Hospital
Miyoung MD Park, PhD
principal investigator · Yeungnam University Hospital
Younggeon MD Lee, PhD
principal investigator · Inje University Ilsan Paik Hospital
Sohun MD Yoon, PhD
principal investigator · National Health Insurance Service Ilsan Hospital
Yeonsil MD Moon, PhD
principal investigator · Konkuk University Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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