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

Dementia Clinical Trial

— ATC-P001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088121
• Other study ID #: CNUH 2023-03-027
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: October 2023
• Source: Advanced Technology & Communications
• Contact: Shin Jinwoo
• Phone: +82314450566
• Email: jinwoo.shin[@]atnci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: June 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Brain Diseases
• Central Nervous System Diseases
• Dementia
• Mental Disorder
• Mental Disorders
• Nervous System Diseases
• Neurocognitive Disorders
• Neurodegenerative Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan	Seo-gu
Korea, Republic of	Chungnam National University Hospital	Daejeon	Jung-gu
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbuk-gu

Sponsors (4)

Lead Sponsor	Collaborator
Advanced Technology & Communications	Chungnam National University Hospital, Dong-A University Hospital, Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	Clinical Dementia Rating(CDR)(Efficacy)	Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating	Week 7, 12, 24
Secondary	Global Deterioration Scale(GDeps)(Efficacy)	Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale	Week 7, 12, 24
Secondary	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
Secondary	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

External Links

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