RecruitingNot ApplicableNCT06088121

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

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


Sponsor

Advanced Technology & Communications

Enrollment

180 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining brain stimulation (TMS) with computer-based cognitive training can slow or improve memory and thinking problems in people with mild Alzheimer's disease. Both tools are non-invasive, and researchers want to see if using them together is more effective than medication alone. **You may be eligible if...** - You are between 60 and 85 years old - You have been diagnosed with mild Alzheimer's disease (CDR 1 or GDS 3) - Your MMSE score is between 21 and 26 (mild impairment range) - You have been on an Alzheimer's medication (acetylcholinesterase inhibitor) for at least 2 months without a dose change - Your diagnosis has been confirmed by amyloid PET scan - A legally authorized representative can consent on your behalf if needed **You may NOT be eligible if...** - You have moderate or severe dementia - You have metal in your head (e.g., cochlear implants, brain stimulators) or a pacemaker - You have a history of seizures - You have another neurological condition causing your cognitive symptoms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEATNC MDD-V1 (Real TMS + Real Cog)

Synchronized TMS and cognitive stimulation to 6 brain areas.

DEVICEATNC 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.

DEVICEATNC BN-V1

The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).

DEVICEATNC BN-V2

The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).


Locations(11)

Catholic university of Korea Incheon St. Mary's Hospital

Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, South Korea

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, Deokan-ro 110, South Korea

jeonbuk National University Hospital

Jeonju, Deokjin-gu, South Korea

Chonnam National University Hopital

Gwangju, Dong-gu, South Korea

Yeungnam University Medical Center

Daegu, Hyeonchung-ro, Nam-gu, South Korea

National Health Insurance Service Ilsan Hospital

Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, South Korea

Inje University Ilsan Paik Hospital

Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si, South Korea

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Konkuk University Medical Center

Seoul, Neungdong-ro, Gwangjin-gu, South Korea

Dong-A University Hospital

Busan, Seo-gu, South Korea

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

View Full Details on ClinicalTrials.gov

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NCT06088121


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