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Evaluating a new treatment for cognitive function in mild Alzheimer's dementia

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

Not applicable Interventional Advanced Technology & Communications · NCT06088121

This study is testing a new treatment that combines brain stimulation and cognitive training to see if it can help people with mild Alzheimer's dementia improve their thinking skills.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment180 (estimated)
Ages60 Years to 85 Years
SexAll
SponsorAdvanced Technology & Communications Industry-sponsored
Drugs / interventionschemotherapy
Locations11 sites (Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu and 10 other locations)
Trial IDNCT06088121 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of the ATNC MDD-V1 system, which combines Transcranial Magnetic Stimulation (TMS) with cognitive training, in improving cognitive function in patients with mild Alzheimer's dementia. Participants will undergo screening to confirm eligibility and will be randomly assigned to either a treatment group receiving the active intervention or a sham group. The treatment involves attending the clinic five times a week for six weeks, with follow-up visits scheduled thereafter. The study aims to enroll up to 158 patients across multiple clinical sites in the Republic of Korea.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 60-85 diagnosed with mild Alzheimer's disease and currently on stable acetylcholinesterase inhibitor therapy.

Not a fit: Patients with severe Alzheimer's disease or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance cognitive function in patients with mild Alzheimer's dementia, potentially improving their quality of life.

How similar studies have performed: While the approach of combining TMS with cognitive training is innovative, similar studies have shown promise in enhancing cognitive function in dementia patients.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

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.

Where this trial is running

Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer's DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.