KCT0008169已完成未知
Single-center, single-group, exploratory clinical trial to confirm the efficacy and safety of the focused ultrasound stimulation system (NS-US200) to improve cognitive function in Alzheimer's disease patients after low-intensity focused ultrasound stimulation in the left dorsolateral prefrontal cortex
eurosona0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 55(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •1) Patients with Alzheimer's disease between 55 and 90 years of age
- •2) Those who were diagnosed with probable Alzheimer's disease according to the Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and meet the criteria for dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-?)
- •3) Dementia patients with a Mini Mental State Examination 2nd (MMSE-?) less than 25
- •4) Patients with a Clinical Dementia Rating (CDR) less than 1
- •5) Patients taking acetylcholinesterase inhibitors (ACEI) and NMDA receptor antagonists (NMDA receptor inhibitors) consistently have the same treatment and dosage for more than 3 months prior to the screening date
- •6) Those who can read and understand the informed consent form, and who is capable of language ability to respond to the questionnaire
- •7) Those who can be accompanied by a guardian when visiting a research institution during the clinical trial process and who can be helped by the guardian to proceed with the clinical trial process normally
- •8) Those who voluntarily decide to participate in this clinical trial and agreed to the informed consent form in writing and can participate in the entire clinical trial
排除标准
- •1) Having a history of epileptic seizures, presently taking anticonvulsants
- •2) Presently taking medication at the department of psychiatry for diseases such as severe depression and schizophrenia other than the inclusion criteria
- •3) Having a history of serious diseases such as cancer/tuberculosis
- •4) Those not suitable for Magnetic Resonance Imaging (MRI)
- •5) Detection of clinical calcification of the brain on computed tomography (CT) or simple radiography
- •6) Long-term use of drugs (e.g., anticholinergic drugs, etc.) that will cause cognitive decline can affect cognitive impairment for more than 10 years
- •7) Those with difficulties to accurately evaluate cognitive function due to the drug being administered
- •8) History of transient ischemic attack, stroke or cerebrovascular disease within one year from the screening date
- •9) Cerebral damage due to trauma, ischemia, hypoxia, etc.
- •10) Difficulty reading the text even with glasses due to decreased vision
- •11) Difficulty hearing even with hearing aid due to hearing impairment
- •12) Difficulty breathing while sitting still
- •13) Suicide attempt within 6 months of the screening date
- •14) Who participated in other clinical trials within 30 days from the screening date
- •15) Women of childbearing potential who do not consent to using contraception *in a medically acceptable manner during this trial
- •*Medically accepted contraceptive methods: condoms, oral contraception for at least 3 months or more, using injectable or injectable contraceptives, installing intrauterine contraceptives, etc.
- •16) Pregnant or breastfeeding
- •17) In addition to the above, those who are judged to be inadequate for participating in the clinical trial by a principal investigator or the person in charge
- •18) Negative for amyloid plaque on Amyloid PET-CT
研究者
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