KCT0009708招募中Unknown
A multicenter, randomized, double-blind, sham-controlled, sponsor-initiated, confirmatory study to evaluate the safety and efficacy of transcranial direct current stimulation (YMS-201B+) of enhancing cognitive function in patients with Alzheimer's disease-type mild cognitive impairment on medication
Ybrain0 个研究点目标入组 190 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
- 190
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
- 55(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •1) Adults men or women between 55 and 90 years of age
- •2) Meet the following according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic guidelines published in 2011
- •All of the following core clinical criteria for Mild cognitive impairment due to Alzheimer's disease* must be met
- •- Concern about previous functional changes
- •- Impairment in one or more of cognitive domains
- •- Maintained independence in overall daily living functioning
- •- Absence of dementia
- •* Subjects diagnosed with mild cognitive impairment due to Alzheimer's disease by tests such as MRI (magnetic resonance image) and/or FDG-PET (F-18 fluorodeoxyglucose Positron Emission Tomography). However, if not diagnosed at Screening, subjects must be diagnosed with mild cognitive impairment due to Alzheimer's disease by MRI and/or FDG-PET prior to Visit 2.
- •3) Mild cognitive impairment with MMSE (Mini Mental State Examination) score of 23 or higher
- •4) CDR (Clinical Dementia Rating) global score not more than 0.5 or GDS (Global Deterioration Scale) score not more than 3
- •5) Those who satisfy the following regarding medications received prior to screening
- •?. Acetylcholinesterase inhibitors (ACEIs), NMDA receptor inhibitors (NMDA receptor inhibitors) have been taken at the same dose and regimen for at least 3 months prior to the screening date; or, drugs for the treatment of cognitive function other than ACEIs and NMDA receptor antagonists have been taken at the same dose and regimen for at least 1 month prior to the screening date.
- •?. For patients taking antidepressants and medications for the treatment of chronic diseases including hypertension, diabetes, hyperlipidemia, thyroid disease, etc.
- •6) Able to read and understand the study consent form and is capable of language proficiency at a level capable of answering the questionnaires
- •7) Able to voluntarily decide on participation and provide written consent, and can participate in the entire period of the clinical trial
排除标准
- •1) Diagnosis of dementia (neurocognitive disorder) based on DSM-? (Diagnostic and Statistical Manual, fifth edition) or ICD-10 (The International Statistical Classification of Disease and Related Health Problems)
- •2) Patients have cognitive deficits due to following diseases: Parkinson's disease, Huntington disease, subdural hemorrhage, central nervous system infections (HIV, syphilis), thyroid disease, deficiency of vitamin V12 or folic acid
- •3) History of axis ? psychiatric disorders including intellectual disabilities, schizophrenia, alcohol addiction, and bipolar disorder
- •4) History of convulsion within 5 years of the screening date
- •5) Those who meet the criteria below through CT or MRI within 1 year of the screening date
- •- Acute or subacute hemorrhage
- •- If unable to document that previous massive hemorrhage (defined as diameter > 1 cm on T2 sequence) or previous sub-arachnoid hemorrhage was not due to underlying structural or vascular abnormalities (i.e., findings do not suggest a risk of relapse for the subject)
- •- Four or more minor hemorrhage (defined as not more than 1 cm in diameter on T2 sequence)
- •- Any cortical infarct or single subcortical infarct greater than 1.5 cm in diameter (In case of diffusion weighted image, more than 2 cm)
- •- Superficial siderosis
- •- History of diffuse white matter disease defined as a score of 3 on the scale of age-related white matter change
- •- According to the investigator, any findings that might contribute to dementia, endager the subject, or could interfere with MRI assessment for safety monitoring
- •* MRI imaging will be Gradient Echo Sequence or Susceptibility-weighted image (SWI) or Diffusion-weighted image (DWI), if no CT or MRI results are available within 1 year of screening to confirm the presence of brain disease.
- •6) Those who have cerebral injury due to trauma, ischemia, hypoxia, etc.
- •7) Those who have been admitted to the hospital for mental illness within 5 years of the screening date
- •8) Those who have abused drugs within 5 years of the screening date
- •9) Those who have been treated for alcohol addiction within 5 years of the screening date
- •10) Difficulty reading the text even with glasses due to decreased vision
- •11) Difficulty understanding conversations even with hearing aid due to hearing impairment
- •12) Difficulty breathing while sitting still
- •13) Suicide attempt within the previous 6 months prior to the screening date
- •14) Problems with electroencephalograms and transcranial direct current stimulation electrodes due to scalp deformities, inflammatory reactions, or other skin problems
- •15) Any other contraindication to the use of a tDCS medical device (e.g., metal plates in the head, etc.)
- •16) Participation in other clinical trials within 30 days from the screening date
- •17) Participation in other clinical trials for mild cognitive impairment due to Alzheimer's disease or early dementia within 1 year from the screening date
- •18) Female subjects 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.)
- •19) Pregnant or breastfeeding women
- •20) 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
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