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

NCT06088121 | Recruiting

• 1 other identifier: CNUH 2023-03-027
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

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

Outcome Measures

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

  Week 24

Secondary Outcomes (6)

• Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)

  Week 7, 12

• Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)

  Week 7, 12, 24

• Clinical Dementia Rating(CDR)(Efficacy)

  Week 7, 12, 24

• Global Deterioration Scale(GDeps)(Efficacy)

  Week 7, 12, 24

• Clinical Global Impression of Change(CGIC)(Efficacy)

  Week 7, 12, 24

Other Outcomes (1)

• Adverse events(AE's)(Safety)

  Week 24

Study Arms (2)

ATNC MDD-V1

ACTIVE COMPARATOR

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 TMS + Real Cog

SHAM COMPARATOR

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

ATNC MDD-V1 (Real TMS + Real Cog) DEVICE

Synchronized TMS and cognitive stimulation to 6 brain areas.

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

ATNC MDD-V1

ATNC MDD-V1 (Sham TMS + Real Cog) DEVICE

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

Sham TMS + Real Cog

ATNC BN-V1 DEVICE

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

ATNC MDD-V1; Sham TMS + Real Cog

ATNC BN-V2 DEVICE

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

ATNC MDD-V1; Sham TMS + Real Cog

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• ※ 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Advanced Technology & Communications: lead
• Chungnam National University Hospital: collaborator
• Dong-A University Hospital: collaborator
• Korea University Anam 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

Study Sites (11)

Catholic university of Korea Incheon St. Mary's Hospital

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

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Deokan-ro 110, 14353, South Korea

RECRUITING

jeonbuk National University Hospital

Jeonju, Deokjin-gu, 54907, South Korea

RECRUITING

Chonnam National University Hopital

Gwangju, Dong-gu, 61469, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, Hyeonchung-ro, Nam-gu, 42415, South Korea

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

RECRUITING

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, Neungdong-ro, Gwangjin-gu, 05030, South Korea

RECRUITING

Dong-A University Hospital

Busan, Seo-gu, 49315, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

RECRUITING

Related Links

• MedlinePlus Genetics related topics: Alzheimer disease
• MedlinePlus related topics: Alzheimer disease
• Other U.S. FDA Resources
• Sponsor's web

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Tauopathies

Study Officials

• Ae Young MD LEE, PhD

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Kun Woo MD Park, PhD

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Deye MD Yoon, PhD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Goun MD Kim, PhD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Su-Hyun MD Jo, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Mincheol MD Park, PhD

  Chung-Ang University Gwangmyeong Hospital

  PRINCIPAL INVESTIGATOR

• Inwook MD Song, PhD

  Incheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Miyoung MD Park, PhD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

• Younggeon MD Lee, PhD

  Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

• Sohun MD Yoon, PhD

  National Health Insurance Service Ilsan Hospital

  PRINCIPAL INVESTIGATOR

• Yeonsil MD Moon, PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Jinwoo

CONTACT

+82314450566; jinwoo.shin@atnci.com

Hyunah Lee

CONTACT

+821079373566; hyunah.lee@atnci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 18, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

KR (11)