KCT0000551招募中未知
Changes of cognitive function in patients with mild to moderate Alzheimer’s disease associated with or without white matter lesions after RivastigminE patch thERapy - A multi-center, prospective, open-label clinical trial (CAREER study)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 300
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
- 50(Year) 至 90(Year)（—）
- 性别
- All
入选标准
- •1. Age range : 50 - 90 years of age
- •2. AD in NINCDS-ADRDA criteria, mild to moderate probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
- •3. MMSE score : 10 to 26 at screening
- •4. Hachinski scores = 4
- •5. Who have a reliable caregiver who met the patient at least once a week and was sufficiently familiar with the patient to provide the investigator with accurate information
- •6. Who are ambulatory or ambulatory-aided (i.e., walker or cane)
排除标准
- •1.Subjects with any primary neurodegenerative disorder or psychiatric disorder other than AD (i.e., Parkinson’s disease, schizophrenia, or major depressive disorder)
- •2.Subjects with clinically significant laboratory abnormalities such as an abnormal thyroid function test, abnormal low level of vitamin B12 or folate, or positive Venereal Disease Research Laboratory test
- •3.Subjects with any history of drug or alcohol addiction for the past 10 years
- •4.Subjects with any severe or unstable medical disease that may have prevented the patient from completing all study requirements (i.e., unstable or severe asthma or cardiovascular disease, active gastric ulcer, severe hepatic or renal disease)
- •5.Subjects with bradycardia with less than 50 beats per minute, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block
- •6. Subjects with any active skin lesion
- •7. Subjects with a history of allergy to topical products containing any of the constitution of the patches
- •8.Subjects who had known hypersensitivity to cholinesterase inhibitors
- •9. Subjects with any hearing or visual impairment that could disturb the efficient evaluation of the patient
- •10. Who had an involvement in other clinical trials or treated by any experimental drug within 4 weeks
- •11. probable AD with severe whiter matter lesion or with smultiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
研究者
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