Clinical trial NCT06088121: Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Advanced Technology & Communications
Sponsor class: INDUSTRY
Collaborators: name: Chungnam National University Hospital
name: Korea University Anam Hospital
name: Dong-A University Hospital
name: Chonnam National University Hospital
name: Chonbuk National University Hospital
name: Chung-Ang University Gwangmyeong Hospital
name: Hanyang University
First posted: 2023-10-18
Enrollment: 158
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)
timeFrame: Week 24
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)
timeFrame: Week 7, 12
measure: Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)
timeFrame: Week 7, 12, 24
measure: Clinical Dementia Rating(CDR)(Efficacy)
timeFrame: Week 7, 12, 24
measure: Global Deterioration Scale(GDeps)(Efficacy)
timeFrame: Week 7, 12, 24
measure: Clinical Global Impression of Change(CGIC)(Efficacy)
timeFrame: Week 7, 12, 24
measure: Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy)
timeFrame: Week 7, 12, 24
Other outcomes:
measure: Adverse events(AE's)(Safety)
timeFrame: Week 24
Locations:
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
state: Deokan-ro 110
city: Jeonju
country: Korea, Republic of
facility: jeonbuk National University Hospital
state: Deokjin-gu
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hopital
state: Dong-gu
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
state: Seo-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
state: Seongdong-gu
Study officials:
affiliation: Chungnam National University Hospital
name: Ae Young MD LEE, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Kun Woo MD Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Kyung Won MD Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Goun MD Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Su-Hyun MD Jo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Gwangmyeong Hospital
name: Mincheol MD Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Heejin MD Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: