耐受性
医学
临床终点
安慰剂
多奈哌齐
内科学
不利影响
随机对照试验
阿尔茨海默病
临床试验
胃肠病学
痴呆
疾病
病理
替代医学
作者
YongSoo Shim,Hyun Jeong Han,Kyung Won Park,Byeong C. Kim,Kee Hyung Park,Mee Young Park,Han Jo Kim,So Young Moon,Seong Hye Choi,Kun Woo Park,Dong Won Yang,Soo Jin Yoon,SangYun Kim,Young Chul Youn,Ho-Jin Choi,Koung Eun Yoon,Hyun-Ju Cho,Seol‐Heui Han
摘要
Background: Preclinical studies in transgenic models of Alzheimer’s disease (AD) suggest that DHP1401 has neuroprotective and memory-enhancing effects. Objective: To evaluate the efficacy and safety of DHP1401 in AD patients treated with donepezil Methods: Methods: In a double-blind study, patients with mild-to-moderate AD were randomized (1:1:1) to receive a twice daily total dose of 500 mg or 1000 mg DHP1401 or placebo for 24 weeks. Tolerability and safety were monitored at baseline and weeks 12 and 24. Results: total of 180 patients were randomized to Active 1 (500 mg: n = 62), Active 2 (1000 mg: n = 53), and control groups (n = 65) in 16 sites in Korea. There was no significant difference in the Alzheimer’s Disease Assessment Scale (ADAS-cog) score, the primary efficacy endpoint, from baseline. However, in the subgroup with mild AD patients (MMSE, 20–26) who received the high dose of DHP1401 and the group that received donepezil 5 mg, the ADAS-cog scores improved. MMSE and K-TMT-e type B were significant in both active groups at week 24. The most frequently observed symptom was dizziness (2.78%), and the most commonly observed reactions were related to metabolism and nutrition disorders (5.00%). No remarkable adverse events were observed for 24 weeks. Conclusion: Although the effectiveness of DHP1401 was not proved to be superior as the primary efficacy endpoint, the secondary endpoints, MMSE and K-TMT-e type B, showed significant beneficial effects. Also, the subgroups showed that ADAS-cog scores significantly were improved. DHP1401 could be proven beneficial for the AD treatment by further clinical trials.
科研通智能强力驱动
Strongly Powered by AbleSci AI