[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the efficacy and safety of Wujia Yizhi Granules in the treatment of mild and moderate Alzheimer's disease (spleen and kidney deficiency syndrome).
1.)主要疗效指标
比较治疗12个月后,五加益智颗粒组与安慰剂组阿尔茨海默病评定量表-认知部分(ADAS-cog/12)评分较基线改变的组间差异。
比较治疗12个月后,五加益智颗粒组与安慰剂组临床痴呆评定量表(CDR-SB)较基线改变的组间差异。
2)次要疗效指标
评估五加益智颗粒的有效性和安全性。试验终点如下:
?治疗期第3、6、9个月阿尔茨海默病评定量表-认知部分(ADAS-cog/12)评分较基线的变化;
?治疗期第3、6、9个月临床痴呆评定量表(CDR-SB)评分较基线的变化;
?治疗期第3、6、9、12个月阿尔茨海默病协作研究组-日常生活能力量表(ADCS-ADL)评分较基线的变化;
?治疗期第3、6、9、12个月简易智能状态检查量表(MMSE)评分较基线的变化;
?治疗期第3、6、9、12个月神经精神科问卷(NPI)评分较基线的变化;
?治疗期第3、6、9、12个月中医证候量表评分较基线的变化;
[Translation] 1.) Main efficacy indicators
Compare the difference between the Wujia Yizhi granules group and the placebo group in the change of the Alzheimer's Disease Rating Scale-Cognitive Part (ADAS-cog/12) score from baseline after 12 months of treatment.
Compare the difference between the Wujia Yizhi granules group and the placebo group in the change of the Clinical Dementia Rating Scale (CDR-SB) from baseline after 12 months of treatment.
2) Secondary efficacy indicators
Evaluate the efficacy and safety of Wujia Yizhi granules. The trial endpoints are as follows:
? Changes in the Alzheimer's Disease Rating Scale-Cognitive Part (ADAS-cog/12) score from baseline at 3, 6, and 9 months of treatment;
? Changes in the Clinical Dementia Rating Scale (CDR-SB) score from baseline at 3, 6, and 9 months of treatment;
? Changes in the Alzheimer's Disease Collaborative Research Group-Daily Living Activities Scale (ADCS-ADL) score from baseline at 3, 6, 9, and 12 months of treatment;
? Changes in Mini-Mental State Examination (MMSE) scores at 3, 6, 9, and 12 months of treatment compared with baseline;
? Changes in Neuropsychiatric Questionnaire (NPI) scores at 3, 6, 9, and 12 months of treatment compared with baseline;
? Changes in Traditional Chinese Medicine Syndrome Scale scores at 3, 6, 9, and 12 months of treatment compared with baseline;