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Alzheimer's DiseaseATC-P001NCT06088121

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

A study testing ATNC MDD-V1 (Real TMS + Real Cog), ATNC BN-V1 and ATNC BN-V2 in people with Alzheimer's Disease and Dementia, run by Advanced Technology & Communications at 11 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease, Dementia, Brain Diseases
What is being tested?
ATNC MDD-V1 (Real TMS + Real Cog), ATNC BN-V1 and ATNC BN-V2
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
11 sitesSouth Korea
Study dates
15 May 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • MMSE score 21 to 26.
  • CDR 1 or GDS 3.
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  • ※ 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.
  • A patient who is deemed physically eligible for the clinical trial based on medical records and physical examination.
  • 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.
  • Patients who agreed to participate in all 24-week clinical trials.
  • Patients with normal ability to see and hear letters.
  • Patients who speak Korean as their mother tongue

Who cannot join

  • 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.
  • Patients with schizophrenia, schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, post-traumatic stress, severe anxiety, mental retardation, DSM-V disorder.
  • 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.
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  • Patients with metal implants in the head, (i.e. cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants.
  • Cardiac pacemakers.
  • Implanted medication pumps.
  • Intracardiac lines.
  • Patients who are currently taking medications that lower the convulsive seizure threshold.
  • Significant heart disease.
  • 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.
  • Contraindication for performing MRI scanning.
  • Contraindication for performing amyloid PET-CT scanning.
  • Patients who do not consent to TMS treatment and participation in this clinical trial.
  • 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.
  • Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial.
  • 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.
  • 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.).
  • Patients who need to take medications suggested in concomitantly contraindicated drugs.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shin Jinwoo contact

+82314450566

jinwoo.shin@atnci.com

Hyunah Lee contact

+821079373566

hyunah.lee@atnci.com

11 sites in 1 country

South Korea11 sites, 11 recruiting

  • Dong-A University Hospital

    Busan, Seo-gu, 49315

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Kyung Won MD Park, PhD

    Recruiting

  • Yeungnam University Medical Center

    Daegu, Hyeonchung-ro, Nam-gu, 42415

    AT&C, +82-31-445-1565, jinwoo.shin@atnci.com

    Miyoung MD Park, Ph.D

    Recruiting

  • Chungnam National University Hospital

    Daejeon, Jung-gu, 35015

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Ae Young MD LEE, PhD

    Recruiting

  • Chonnam National University Hopital

    Gwangju, Dong-gu, 61469

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Goun MD Kim, Ph.D

    Recruiting

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong, Deokan-ro 110, 14353

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Mincheol MD Park, Ph.D

    Recruiting

  • National Health Insurance Service Ilsan Hospital

    Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, 10444

    AT&C, +82-31-445-1565, jinwoo.shin@atnci.com

    Sohun MD Yoon, Ph.D

    Recruiting

  • Inje University Ilsan Paik Hospital

    Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si, 10380

    AT&C, +82-31-445-1565, jinwoo.shin@atnci.com

    Younggeon MD Lee, Ph.D

    Recruiting

  • Catholic university of Korea Incheon St. Mary's Hospital

    Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, 403-720

    AT&C, +82-31-445-1565, jinwoo.shin@atnci.com

    Inwook MD Song, Ph.D

    Recruiting

  • jeonbuk National University Hospital

    Jeonju, Deokjin-gu, 54907

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Su-Hyun MD Jo, Ph.D

    Recruiting

  • Konkuk University Medical Center

    Seoul, Neungdong-ro, Gwangjin-gu, 05030

    AT&C, +82-31-445-1565, jinwoo.shin@atnci.com

    Yeonsil MD Moon, PhD

    Recruiting

  • Korea University Anam Hospital

    Seoul, Seongbuk-gu, 02841

    AT&C, +82-31-445-1565, hyunah.lee@atnci.com

    Kun Woo MD Park, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: Effects of a ATNC MDD-V1 (TMS With Cognitive Training), for the Treatment of Mild Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study

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.

Being tested
ATNC MDD-V1 (Real TMS + Real Cog), ATNC MDD-V1 (Sham TMS + Real Cog), ATNC BN-V1, ATNC BN-V2
Keywords
TMS, Cognitive Stimulation, ATNC MDD-V1, Dementia
Medical subject headings
Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATNC MDD-V1 (Real TMS + Real Cog)Device

    Also called ATNC MDD-V1, Brain Sense & Brain Cog

    Synchronized TMS and cognitive stimulation to 6 brain areas.

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

    Also called sham

    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.

  • ATNC BN-V1Device

    Also called Brain Navigation System V1

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

  • ATNC BN-V2Device

    Also called Brain Navigation System V2

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

Study groups in NCT06088121
Study groupRoleWhat they receive
ATNC MDD-V1Active comparatorATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
Receives: Device: ATNC MDD-V1 (Real TMS + Real Cog); Device: ATNC BN-V1; Device: ATNC BN-V2
Sham TMS + Real CogSham comparatorThe 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.
Receives: Device: ATNC MDD-V1 (Sham TMS + Real Cog); Device: ATNC BN-V1; Device: ATNC BN-V2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 24

Secondary outcomes (6)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Week 7, 12, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start15 May 2023
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088121
Sponsor's protocol ID
CNUH 2023-03-027
Acronym
ATC-P001
Status last verified
Apr 2026
First submitted
19 Sep 2023
Last updated
23 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ATNC MDD-V1 (Real TMS + Real Cog), ATNC BN-V1 and ATNC BN-V2 in people with Alzheimer's Disease and Dementia, run by Advanced Technology & Communications at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shin Jinwoo (+82314450566, jinwoo.shin@atnci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy) (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088121.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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