KCT0008918招募中Unknown
A multi-center, Randomized, Double-blind, Prospective, Pilot study to evaluate the safety and efficacy of optimized transcranial direct current stimulation for the transitory cognitive improvement in patients with mild cognitive impairment due to Alzheimer’s disease on medication
europhet0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 60(Year) 至 85(Year)（—）
- 性别
- All
入选标准
- •1. Men and women between 60 and 85 years old
- •2. According to the diagnosis guidelines of the National Institute on Aging and the Alzheimer's Association (NIA-AA), the following items 1) and 2) must be satisfied
- •1) Fulfills all key clinical criteria for mild cognitive impairment due to Alzheimer's disease
- •2) Corresponds to the medium or high standard for mild cognitive impairment research containing biomarkers
- •3. Patients with mild cognitive impairment with a K-MMSE (Mini-Mental State Examination) score of 23 or higher
- •4. CDR (Clinical Dementia Rating) global score below 0.5 or GDS (global deterioration scale) score below 3 points
- •5. Acetylcholinesterase inhibitors (ACEI) and NMDA receptor antagonists (NMDA receptor inhibitors) are subject to the same usage and dose for more than 3 months from the screening date
- •6. Those who can read and understand the study explanation and ICF, and have language skills at a level to be able to respond to the questionnaire
- •7. Those who have voluntarily decided to participate in this clinical trial and have given written consent to the informed consent form, who can participate throughout the entire period of the clinical study
排除标准
- •1. A person diagnosed with dementia in accordance with the criteria of DSM5 or ICD10
- •2. Patients with cognitive impairment due to the following conditions: Parkinson's disease, Huntington's disease, subdural hematoma, etc
- •3. A person with a history of past psychiatric disorders
- •4. A person who has a history of seizures within five years from the date of screening
- •5. A person who comes under the following criteria in a CT or MRI imaging examination within one year from the date of screening
- •- acute or subacute bleeding
- •- Previous massive hemorrhage or previous subarachnoid hemorrhage due to underlying structural abnormalities or vascular abnormalities
- •- Four or more microbleeds
- •- A history of chronic white matter disease defined as 3 points in age-related ARWC
- •6. A person who has cerebral damage due to trauma, ischemia, hypoxia, etc
- •7. A person who has been hospitalized for mental or emotional problems within five years of the date of screening
- •8. A person who has abused a drug within five years of the date of screening
- •9. A person who has been treated for alcoholism within five years of the date of screening
- •10. A person who cannot read due to reduced vision
- •11. A person who has difficulty understanding a conversation due to hearing impairment
- •12. A person who has difficulty breathing when sitting still
- •13. A person who has attempted suicide within six months from the date of screening
- •14. A person who is considered to have a problem with attaching electrodes for electroencephalography and direct current stimulation
- •15. A person who is considered to have other reasons for the prohibition of the use of the tDCS (e.g., when a metal plate is inserted into the head, etc.)
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