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Tests treatment safety and results for Alzheimer's Disease
Official title Study to Evaluate the Efficacy and Safety of ATNC-MDD V1(TMS With Cognitive Training) in Mild Alzheimer's Dementia
ClinicalTrials.gov ID: NCT06088121
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85
You may be able to join if
- Patients who started drug treatment with an acetylcholinesterase inhibitor at least 2 months before participating in the clinical trial and can...
- Male or female age 60-85 years.
- Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
- A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.
- MMSE score 21 to 26.
You likely can't join if
- Patients with central nervous system (CNS) disorders that may affect cognitive function (such as cerebrovascular diseases including vascular...
- Patients who have been unconscious due to brain surgery or concussion, or who have signs or symptoms of cranial pressure elevation on neurologic...
- 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...
- Patients with abnormal vitamin B12, folic acid deficiency, or thyroid stimulating hormone (TSH) test results that were considered by the investigator...
See the full eligibility 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...
- Male or female age 60-85 years.
- Patients diagnosed with mild stage of Alzheimer's Disease, according to the NIA-AA (2011) diagnosis.
- A patient whose dementia was confirmed to be due to Alzheimer's disease by amyloid PET-CT.
- MMSE score 21 to 26.
- CDR 1 or GDS 3. ※ For people who are excluded from screening based on criteria 5 or 6, if the investigator judges that the subject is likely to be eligible, one repeat screening may be performed.
- A patient who is deemed physically eligible for the clinical trial based on medical records and physical examination.
- A patient who is unable to provide voluntary informed consent for the clinical trial due to impaired decision-making capacity, for whom a legally authorized representative provides consent for participation, and who can...
- 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
- Patients with central nervous system (CNS) disorders that may affect cognitive function (such as cerebrovascular diseases including vascular dementia, subdural hematoma, normal pressure hydrocephalus, brain tumors, CNS...
- 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.
- Patients with severe renal or hepatic impairment※, referring to conditions that significantly affect daily living (e.g., stage 4 chronic kidney disease), with the assessment based on the investigator's judgment.
- 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. ※ people who participate in non-treatment studies (such as observational studies) that do not affect the subject's...
- 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. ※ If the test subject is unable to visit according to the research plan due to unavoidable personal...
- 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...
- Patients who need to take medications suggested in concomitantly contraindicated drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, South Korea
- Gwangmyeong, Deokan-ro 110, South Korea
- Jeonju, Deokjin-gu, South Korea
- Gwangju, Dong-gu, South Korea
- Daegu, Hyeonchung-ro, Nam-gu, South Korea
- Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, South Korea
- Gyeonggi-do, Juhwa-ro, Ilsanseo-gu, Goyang-si, South Korea
- Daejeon, Jung-gu, South Korea
- Seoul, Neungdong-ro, Gwangjin-gu, South Korea
- Busan, Seo-gu, South Korea
- Seoul, Seongbuk-gu, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Incheon, Bupyeong 6(yuk)-dong, Bupyeong-gu, South Korea; Gwangmyeong, Deokan-ro 110, South Korea; Jeonju, Deokjin-gu, South Korea; Gwangju, Dong-gu, South Korea; Daegu, Hyeonchung-ro, Nam-gu, South Korea; Gyeonggi-do, Ilsan-ro, Ilsandong-gu, Goyang-si, South Korea and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.