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

Not Applicable

Recruiting

• Conditions: Alzheimer's Disease; Neurodegenerative Diseases; Dementia; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Brain Diseases; Mental Disorder
• Interventions: Device: ATNC MDD-V1 (Real TMS + Real Cog); Device: ATNC MDD-V1 (Sham TMS + Real Cog); Device: ATNC BN-V1; Device: ATNC BN-V2

• Registration Number: NCT06088121
• Lead Sponsor: Advanced Technology & Communications

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.

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 7 clinical sites in the Republic Korea.

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 158

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.

   ※ Applicants who have not passed the screening according to inclusion criteria 5 or 6 may be re-examined once if the examiner determines that they are likely to be suitable.

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

Read More

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.

    ※ 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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TMS + Real Cog	ATNC BN-V1	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.
Sham TMS + Real Cog	ATNC BN-V2	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	ATNC BN-V1	ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
ATNC MDD-V1	ATNC BN-V2	ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
ATNC MDD-V1	ATNC MDD-V1 (Real TMS + Real Cog)	ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
Sham TMS + Real Cog	ATNC MDD-V1 (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.

Primary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)	Week 24	Change from Baseline to 24 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)	Week 7, 12	Change from Baseline to 7,12 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Clinical Dementia Rating(CDR)(Efficacy)	Week 7, 12, 24	Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating
Global Deterioration Scale(GDeps)(Efficacy)	Week 7, 12, 24	Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale
Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy)	Week 7, 12, 24	Change from Baseline to 7, 12 and 24 weeks in K-IADL. K-IADL: Korean-Instrumental Activities of Daily Living
Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)	Week 7, 12, 24	Change from Baseline to 7, 12 and 24 weeks in K-MMSE-2. K-MMSE-2: Korean-Mini Mental State Examination-2nd Edition
Clinical Global Impression of Change(CGIC)(Efficacy)	Week 7, 12, 24	Change from Baseline to 7, 12 and 24 weeks in CGIC CGIC: Clinical Global Impression of Change

Trial Locations

Locations (7)

Chonnam National University Hopital; 🇰🇷 Gwangju, Dong-gu, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Seongbuk-gu, Korea, Republic of

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, Deokan-ro 110, Korea, Republic of

jeonbuk National University Hospital; 🇰🇷 Jeonju, Deokjin-gu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Jung-gu, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Busan, Seo-gu, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Seongdong-gu, Korea, Republic of