KCT0006236招募中未知
A Single-center, Randomized, Parallel design, Phase 2 trial to Evaluate the Efficacy of Donepezil for improvement in visuospatial abilities in Patients with Mild Cognitive Impairment
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 70
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
- 60?(Year) 至 90?(Year)（—）
- 性别
- All
入选标准
- •1. =60 and <90 years of age
- •2. Mild cognitive impairment (Peterson Criteria)
- •3. More than 6 years of education (more than elementary school graduation)
- •4. Normal visual acuity
- •5. Completion of a dementia work-up including neuropsychological tests and MRI
- •6. Amyloid PET scan positive
- •7. K-MMSE =19 points
排除标准
- •1. Structural lesions
- •(such as territorial infarction, intracranial haemorrhage, brain tumour, hydrocephalus)
- •2. Severe white matter hyperintensities (WMH) observed on brain MR image
- •(severe WMH on MRI was defined as a cap or a band =10?mm as well as a deep white matter lesion =25?mm as modified from the Fazekas ischemia criteria)
- •3.When the following drugs are administered: rivastigmine, galantamin, and memantine among Cholinesterase inhibitors
- •4. Patients with neurological abnormalities that may cause memory impairment on medical examination
- •5. Persons with a history of one-axis psychiatric disorders, including intellectual disabilities, schizophrenia, alcoholism, and bipolar desorder
- •6. Those who have a history of malignant diseases(cancer) within the last 3 years. However, Cerviacl Carcinoma in Situ or Nonmelanoma Skin Cancer is excluded.
- •7. Those who have undergone cerebrovascular surgery such as brain surgery or carotid artery surgery
- •8. Those who have difficulty breathing when sitting still
- •9. Those who have had a memory disorder, language disorder, or problem solving ability disorder for more than 2 hours after a heart attack
- •10. Persons with a history of hospitalization for mental or emotional problems within the last 5 years
- •11. Those with a history of abuse of drugs within the last 5 years
- •12. Those with a history of receiving treatment for alcoholism within the last 5 years
- •13. Those who have lost consciousness for more than 1 hour due to causes other than general anesthesia
- •14. Those who have been hospitalized for a head injury
- •15. Those who are unable to read ordinary letters even with glasses due to decreased vision
- •16. Those who have difficulty understanding conversations due to hearing impairment even when wearing hearing aids
- •17. Those who determine that the investigator is unsuitable for participation in the clinical trial
研究者
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