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

Официальное название

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

Обзор

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.

Подробное описание

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 180 patients will be enrolled in up to 11 clinical sites in the Republic Korea.

Вмешательства

• Устройство ATNC MDD-V1 (Real TMS + Real Cog)
  Synchronized TMS and cognitive stimulation to 6 brain areas.
• Устройство 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.
• Устройство ATNC BN-V1
  The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).
• Устройство ATNC BN-V2
  The navigation system is used to determine the exact brain location to be stimulated (coordinates for the stimulation point).

Первичные конечные точки

• Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy) [Срок оценки: Week 24]

Вторичные конечные точки (6)

• Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy) [Срок оценки: Week 7, 12]
• Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy) [Срок оценки: Week 7, 12, 24]
• Clinical Dementia Rating(CDR)(Efficacy) [Срок оценки: Week 7, 12, 24]
• Global Deterioration Scale(GDeps)(Efficacy) [Срок оценки: Week 7, 12, 24]
• Clinical Global Impression of Change(CGIC)(Efficacy) [Срок оценки: Week 7, 12, 24]
• Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy) [Срок оценки: Week 7, 12, 24]

Критерии участия

Критерии включения

• 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.
• 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 subjects 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 attend follow-up visits with a caregiver.
• 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

Критерии исключения

• 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 infections like HIV or syphilis, head trauma, Huntington's disease, Parkinson's disease, etc.) where cognitive decline may be explained by other causes, or in whom dementia types other than Alzheimer's disease are 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.
• 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.

※ 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.

• 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 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.

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

South Korea · 11 центров

• Catholic university of Korea Incheon St. Mary's Hospital — Incheon
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong
• jeonbuk National University Hospital — Jeonju
• Chonnam National University Hopital — Gwangju
• Yeungnam University Medical Center — Daegu
• National Health Insurance Service Ilsan Hospital — Gyeonggi-do
• Inje University Ilsan Paik Hospital — Gyeonggi-do
• Chungnam National University Hospital — Daejeon
• … и ещё 3 центра

Идентификаторы

NCT: NCT06088121 · CNUH 2023-03-027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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