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

Primary Purpose

Alzheimer's Disease, Dementia, Brain Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ATNC MDD-V1 (Real TMS + Real Cog)
ATNC MDD-V1 (Sham TMS + Real Cog)
Sponsored by
Advanced Technology & Communications
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring TMS, Cognitive Stimulation, ATNC MDD-V1, Dementia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. MMSE score 21 to 26. CDR 1 or GDS 3. Patients with a positive amyloid PET-CT. Patients who are judged physically capable of clinical trials based on medical records and examinations. Patient whose legal representative agrees to participate in a clinical trial and who can visit for the next observation with a guardian. 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 Exclusion Criteria: 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. 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. Significant renal disease, Significant hepatic disease. Contraindication for performing MRI scanning. Contraindication for performing amyloid PET-CT scanning. Patients who do not consent to TMS treatment and participation in this clinical trial. Patients who participated in other clinical trials 3 months before participating in this clinical trial. Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial. Patients judged by the investigator to be unsuitable for participation in clinical trials for other reasons. 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.). Patients who need to take medications suggested in concomitantly contraindicated drugs.

Sites / Locations

  • Chungnam National University HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Korea University Anam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ATNC MDD-V1

Sham TMS + Real Cog

Arm Description

ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2023
Last Updated
October 11, 2023
Sponsor
Advanced Technology & Communications
Collaborators
Chungnam National University Hospital, Korea University Anam Hospital, Dong-A University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06088121
Brief Title
Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Technology & Communications
Collaborators
Chungnam National University Hospital, Korea University Anam Hospital, Dong-A University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 3 clinical sites in the Republic Korea.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ATNC MDD-V1
Arm Type
Active Comparator
Arm Description
ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
Arm Title
Sham TMS + Real Cog
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ATNC MDD-V1 (Real TMS + Real Cog)
Other Intervention Name(s)
ATNC MDD-V1, Brain Sense & Brain Cog
Intervention Description
Synchronized TMS and cognitive stimulation to 6 brain areas.
Intervention Type
Device
Intervention Name(s)
ATNC MDD-V1 (Sham TMS + Real Cog)
Other Intervention Name(s)
sham
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)
Description
Change from Baseline to 24 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)
Description
Change from Baseline to 7,12 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
Time Frame
Week 7, 12
Title
Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)
Description
Change from Baseline to 7, 12 and 24 weeks in K-MMSE-2. K-MMSE-2: Korean-Mini Mental State Examination-2nd Edition
Time Frame
Week 7, 12, 24
Title
Clinical Dementia Rating(CDR)(Efficacy)
Description
Change from Baseline to 7, 12 and 24 weeks in CDR. CDR: Clinical Dementia Rating
Time Frame
Week 7, 12, 24
Title
Global Deterioration Scale(GDeps)(Efficacy)
Description
Change from Baseline to 7, 12 and 24 weeks in GDeps. GDeps: Global Deterioration Scale
Time Frame
Week 7, 12, 24
Title
Clinical Global Impression of Change(CGIC)(Efficacy)
Description
Change from Baseline to 7, 12 and 24 weeks in CGIC CGIC: Clinical Global Impression of Change
Time Frame
Week 7, 12, 24
Title
Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy)
Description
Change from Baseline to 7, 12 and 24 weeks in K-IADL. K-IADL: Korean-Instrumental Activities of Daily Living
Time Frame
Week 7, 12, 24
Other Pre-specified Outcome Measures:
Title
Adverse events(AE's)(Safety)
Description
Adverse events (AE's), including serious adverse events (SAEs) occurring at any time during the trial and follow-up.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. MMSE score 21 to 26. CDR 1 or GDS 3. Patients with a positive amyloid PET-CT. Patients who are judged physically capable of clinical trials based on medical records and examinations. Patient whose legal representative agrees to participate in a clinical trial and who can visit for the next observation with a guardian. 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 Exclusion Criteria: 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. 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. Significant renal disease, Significant hepatic disease. Contraindication for performing MRI scanning. Contraindication for performing amyloid PET-CT scanning. Patients who do not consent to TMS treatment and participation in this clinical trial. Patients who participated in other clinical trials 3 months before participating in this clinical trial. Patients with a history of TMS treatment within the last 2 years before participating in this clinical trial. Patients judged by the investigator to be unsuitable for participation in clinical trials for other reasons. 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.). Patients who need to take medications suggested in concomitantly contraindicated drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shin Jinwoo
Phone
+82314450566
Email
jinwoo.shin@atnci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Woong Park
Phone
+821050439405
Email
chunwoong.park@atnci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ae Young MD LEE, PhD
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kun Woo MD Park, PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyung Won MD Park, PhD
Organizational Affiliation
Dong-A University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Jung-gu
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AT&C
Phone
+82-31-445-0566
Email
chunwoong.park@atnci.com
First Name & Middle Initial & Last Name & Degree
Ae Young MD LEE, PhD
Facility Name
Dong-A University Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
49315
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AT&C
Phone
+82-31-445-0566
Email
chunwoong.park@atnci.com
First Name & Middle Initial & Last Name & Degree
Kyung Won MD Park, PhD
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AT&C
Phone
+82-31-445-0566
Email
chunwoong.park@atnci.com
First Name & Middle Initial & Last Name & Degree
Kun Woo MD Park, PhD

12. IPD Sharing Statement

Links:
URL
https://medlineplus.gov/genetics/condition/alzheimer-disease
Description
MedlinePlus Genetics related topics: Alzheimer disease
URL
https://medlineplus.gov/alzheimersdisease.html
Description
MedlinePlus related topics: Alzheimer disease
URL
https://rarediseases.info.nih.gov/diseases/632/familial-alzheimer-disease
Description
Genetic and Rare Diseases Information Center resources: Familial Alzheimer disease
URL
https://classic.clinicaltrials.gov/ct2/info/fdalinks
Description
Other U.S. FDA Resources
URL
https://atnci.com
Description
Sponsor's web

Learn more about this trial

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

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