Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia (ATC-P001)

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Alzheimer's Disease; Mental Disorder
• Intervention / Treatment: Device: ATNC MDD-V1 (Real TMS + Real Cog); Device: ATNC MDD-V1 (Sham TMS + Real Cog)

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 158 patients will be enrolled in up to 3 clinical sites in the Republic Korea.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shin Jinwoo; Phone Number: +82314450566; Email: jinwoo.shin@atnci.com
• Study Contact Backup: Name: Chun Woong Park; Phone Number: +821050439405; Email: chunwoong.park@atnci.com

Study Locations

• Korea, Republic of
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Recruiting
      • Chungnam National University Hospital
      • Contact: AT&C; Phone Number: +82-31-445-0566; Email: chunwoong.park@atnci.com
      • Principal Investigator: Ae Young MD LEE, PhD
  • Seo-gu
    • Busan, Seo-gu, Korea, Republic of, 49315
      • Recruiting
      • Dong-A University Hospital
      • Contact: AT&C; Phone Number: +82-31-445-0566; Email: chunwoong.park@atnci.com
      • Principal Investigator: Kyung Won MD Park, PhD
  • Seongbuk-gu
    • Seoul, Seongbuk-gu, Korea, Republic of, 02841
      • Recruiting
      • Korea University Anam Hospital
      • Contact: AT&C; Phone Number: +82-31-445-0566; Email: chunwoong.park@atnci.com
      • Principal Investigator: Kun Woo MD Park, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. MMSE score 21 to 26.
5. CDR 1 or GDS 3.
6. Patients with a positive amyloid PET-CT.
7. Patients who are judged physically capable of clinical trials based on medical records and examinations.
8. Patient whose legal representative agrees to participate in a clinical trial and who can visit for the next observation with a guardian.
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 a central nervous system disease that can affect cognitive function and is likely to be another cause of cognitive decline, or a type of dementia other than Alzheimer's, is 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. Significant renal disease, Significant hepatic disease.
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.
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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ATNC MDD-V1; ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation	Device: ATNC MDD-V1 (Real TMS + Real Cog); Synchronized TMS and cognitive stimulation to 6 brain areas.; Other Names: ATNC MDD-V1; Brain Sense & Brain Cog
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); 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.; Other Names: sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Week 7, 12
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	Week 7, 12, 24
Clinical Dementia Rating(CDR)(Efficacy)	Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating	Week 7, 12, 24
Global Deterioration Scale(GDeps)(Efficacy)	Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale	Week 7, 12, 24
Clinical Global Impression of Change(CGIC)(Efficacy)	Change from Baseline to 7, 12 and 24 weeks in CGIC CGIC: Clinical Global Impression of Change	Week 7, 12, 24
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	Week 7, 12, 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events(AE's)(Safety)	Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up.	Week 24

Collaborators and Investigators

• Sponsor: Advanced Technology & Communications
• Collaborators: Korea University Anam Hospital; Dong-A University Hospital; Chungnam National University Hospital
• Investigators: Principal Investigator: Ae Young MD LEE, PhD, Chungnam National University Hospital; Principal Investigator: Kun Woo MD Park, PhD, Korea University Anam Hospital; Principal Investigator: Kyung Won MD Park, PhD, Dong-A University Hospital

Publications and helpful links

Helpful Links

• MedlinePlus Genetics related topics: Alzheimer disease
• MedlinePlus related topics: Alzheimer disease
• Genetic and Rare Diseases Information Center resources: Familial Alzheimer disease
• Other U.S. FDA Resources
• Sponsor's web

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dementia; TMS; Cognitive Stimulation; ATNC MDD-V1
• Additional Relevant MeSH Terms: Tauopathies; Mental Disorders; Dementia; Nervous System Diseases; Alzheimer Disease; Brain Diseases; Neurodegenerative Diseases; Central Nervous System Diseases; Neurocognitive Disorders
• Other Study ID Numbers: CNUH 2023-03-027

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No