Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia
NCT ID: NCT06088121
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
158 participants
INTERVENTIONAL
2023-05-15
2027-06-30
Brief Summary
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Detailed Description
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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 158 patients will be enrolled in up to 7 clinical sites in the Republic Korea.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ATNC MDD-V1
ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
ATNC MDD-V1 (Real TMS + Real Cog)
Synchronized TMS and cognitive stimulation to 6 brain areas.
ATNC BN-V1
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
ATNC BN-V2
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
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.
ATNC 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.
ATNC BN-V1
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
ATNC BN-V2
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
Interventions
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ATNC MDD-V1 (Real TMS + Real Cog)
Synchronized TMS and cognitive stimulation to 6 brain areas.
ATNC 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.
ATNC BN-V1
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
ATNC BN-V2
The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
60 Years
85 Years
ALL
No
Sponsors
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Chungnam National University Hospital
OTHER
Korea University Anam Hospital
OTHER
Dong-A University Hospital
OTHER
Chonnam National University Hospital
OTHER
Chonbuk National University Hospital
OTHER
Chung-Ang University Gwangmyeong Hospital
OTHER
Yeungnam University Hospital
OTHER
Inje University Ilsan Paik Hospital
OTHER
National Health Insurance Service Ilsan Hospital
OTHER
Konkuk University Medical Center
OTHER
Advanced Technology & Communications
INDUSTRY
Responsible Party
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Principal Investigators
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Ae Young MD LEE, PhD
Role: PRINCIPAL_INVESTIGATOR
Chungnam National University Hospital
Kun Woo MD Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Deye MD Yoon, PhD
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Goun MD Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Su-Hyun MD Jo, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonnam National University Hospital
Mincheol MD Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Gwangmyeong Hospital
Inwook MD Song, PhD
Role: PRINCIPAL_INVESTIGATOR
Incheon St.Mary's Hospital
Miyoung MD Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Yeungnam University Hospital
Younggeon MD Lee, PhD
Role: PRINCIPAL_INVESTIGATOR
Inje University Ilsan Paik Hospital
Sohun MD Yoon, PhD
Role: PRINCIPAL_INVESTIGATOR
National Health Insurance Service Ilsan Hospital
Yeonsil MD Moon, PhD
Role: PRINCIPAL_INVESTIGATOR
Konkuk University Medical Center
Locations
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Catholic university of Korea Incheon St. Mary's Hospital
Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Deokan-ro 110, South Korea
jeonbuk National University Hospital
Jeonju, Deokjin-gu, South Korea
Chonnam National University Hopital
Gwangju, Dong-gu, South Korea
Yeungnam University Medical Center
Daegu, Hyeonchung-ro, Nam-gu, South Korea
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, South Korea
Inje University Ilsan Paik Hospital
Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si, South Korea
Chungnam National University Hospital
Daejeon, Jung-gu, South Korea
Konkuk University Medical Center
Seoul, Neungdong-ro, Gwangjin-gu, South Korea
Dong-A University Hospital
Busan, Seo-gu, South Korea
Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MedlinePlus Genetics related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer disease
Other U.S. FDA Resources
Sponsor's web
Other Identifiers
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CNUH 2023-03-027
Identifier Type: -
Identifier Source: org_study_id
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