评价芬克罗酮片治疗轻中度阿尔茨海默病安全性、有效性的单中心、单药、开放Ⅱa期临床试验
[Translation] A single-center, single-drug, open-label phase IIa clinical trial to evaluate the safety and efficacy of fenclofenone tablets in the treatment of mild to moderate Alzheimer's disease
观察试验用药到达脑脊液的速度和程度,以及脑脊液药物浓度与血药浓度的关联性。同时评价芬克罗酮片治疗轻、中度的阿尔茨海默病的安全性、有效性和初步判断血药浓度与总体疗效的吻合度。
[Translation] Observe the speed and extent of the test drug reaching the cerebrospinal fluid, as well as the correlation between the cerebrospinal fluid drug concentration and the blood drug concentration. At the same time, evaluate the safety and effectiveness of Fenclotone tablets in the treatment of mild and moderate Alzheimer's disease and preliminarily judge the consistency between the blood drug concentration and the overall efficacy.
评价芬克罗酮片治疗轻中度阿尔茨海默病安全性、有效性的单中心、随机、双盲、安慰剂对照Ⅱa期临床试验
[Translation] A single-center, randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the safety and efficacy of fenclofenone tablets in the treatment of mild to moderate Alzheimer's disease
初步评价芬克罗酮片治疗轻、中度阿尔茨海默病的安全性、有效性和初步判断血药浓度与总体疗效的吻合度。
[Translation] To preliminarily evaluate the safety and efficacy of Fenclotone Tablets in the treatment of mild and moderate Alzheimer's disease and to preliminarily determine the consistency between blood drug concentration and overall efficacy.
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