Effects of a ATNC MDD-V1 (TMS With Cognitive Training), for the Treatment of Mild Alzheimer Disease: a Randomized, Double-blinded, Placebo-controlled Study
概览
- 阶段
- 不适用
- 干预措施
- ATNC MDD-V1 (Real TMS + Real Cog)
- 疾病 / 适应症
- Alzheimer's Disease
- 发起方
- Advanced Technology & Communications
- 入组人数
- 180
- 试验地点
- 22
- 主要终点
- Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)
- 状态
- 招募中
- 最后更新
- 9天前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
- •CDR 1 or GDS
- •※ 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.
排除标准
- •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.
研究组 & 干预措施
ATNC MDD-V1
ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
干预措施: ATNC MDD-V1 (Real TMS + Real Cog)
ATNC MDD-V1
ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
干预措施: ATNC BN-V1
ATNC MDD-V1
ATNC MDD-V1 treatment, synchronized TMS and cognitive training stimulation
干预措施: ATNC BN-V2
Sham TMS + Real Cog
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.
干预措施: ATNC MDD-V1 (Sham TMS + Real Cog)
Sham TMS + Real Cog
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.
干预措施: ATNC BN-V1
Sham TMS + Real Cog
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.
干预措施: ATNC BN-V2
结局指标
主要结局
Alzheimer's Disease Assessment Scale-Cognition Score (Efficacy)
时间窗: Week 24
Change from Baseline to 24 weeks in ADAS-Cog score. ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive
次要结局
- Alzheimer's Disease Assessment Scale-Cognitive(ADAS-cog) Score (Efficacy)(Week 7, 12)
- Clinical Dementia Rating(CDR)(Efficacy)(Week 7, 12, 24)
- Global Deterioration Scale(GDeps)(Efficacy)(Week 7, 12, 24)
- Korean-Instrumental Activities of Daily Living(K-IADL)(Efficacy)(Week 7, 12, 24)
- Korean-Mini Mental State Examination-2nd Edition(K-MMSE-2)(Efficacy)(Week 7, 12, 24)
- Clinical Global Impression of Change(CGIC)(Efficacy)(Week 7, 12, 24)