A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA)
DC Field | Value | Language |
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dc.contributor.author | Shim, YongSoo | - |
dc.contributor.author | Han, Hyun Jeong | - |
dc.contributor.author | Park, Kyung Won | - |
dc.contributor.author | Kim, Byeong C. | - |
dc.contributor.author | Park, Kee Hyung | - |
dc.contributor.author | Park, Mee Young | - |
dc.contributor.author | Kim, Hee-Jin | - |
dc.contributor.author | Moon, So Young | - |
dc.contributor.author | Choi, Seong Hye | - |
dc.contributor.author | Park, Kun Woo | - |
dc.contributor.author | Yang, Dong Won | - |
dc.contributor.author | Yoon, Soo Jin | - |
dc.contributor.author | Kim, Sang Yun | - |
dc.contributor.author | Youn, Young Chul | - |
dc.contributor.author | Choi, Hojin | - |
dc.contributor.author | Yoon, Koung Eun | - |
dc.contributor.author | Cho, Hyun Ju | - |
dc.contributor.author | Han, Seol-Heui | - |
dc.date.accessioned | 2022-06-12T13:40:15Z | - |
dc.date.available | 2022-06-12T13:40:15Z | - |
dc.date.created | 2022-06-09 | - |
dc.date.issued | 2022 | - |
dc.identifier.issn | 1387-2877 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/142140 | - |
dc.description.abstract | 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: 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: A 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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | IOS PRESS | - |
dc.subject | INDUCED MEMORY IMPAIRMENT | - |
dc.subject | CHOLINESTERASE-INHIBITORS | - |
dc.subject | ADENYLYL-CYCLASE | - |
dc.subject | DEMENTIA | - |
dc.subject | SPINOSIN | - |
dc.subject | DIAGNOSIS | - |
dc.subject | KINASE | - |
dc.subject | SEED | - |
dc.subject | MAP | - |
dc.title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Study to Evaluate the Safety and Efficacy of DHP1401 in Patients with Mild to Moderate Alzheimer's Disease Treated with Donepezil: DHP1401 Randomized Trial in Mild to Moderate Alzheimer's Disease (DRAMA) | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Park, Kun Woo | - |
dc.identifier.doi | 10.3233/JAD-215277 | - |
dc.identifier.scopusid | 2-s2.0-85130005599 | - |
dc.identifier.wosid | 000792639200028 | - |
dc.identifier.bibliographicCitation | JOURNAL OF ALZHEIMERS DISEASE, v.87, no.1, pp.391 - 403 | - |
dc.relation.isPartOf | JOURNAL OF ALZHEIMERS DISEASE | - |
dc.citation.title | JOURNAL OF ALZHEIMERS DISEASE | - |
dc.citation.volume | 87 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 391 | - |
dc.citation.endPage | 403 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Neurosciences & Neurology | - |
dc.relation.journalWebOfScienceCategory | Neurosciences | - |
dc.subject.keywordPlus | INDUCED MEMORY IMPAIRMENT | - |
dc.subject.keywordPlus | CHOLINESTERASE-INHIBITORS | - |
dc.subject.keywordPlus | ADENYLYL-CYCLASE | - |
dc.subject.keywordPlus | DEMENTIA | - |
dc.subject.keywordPlus | SPINOSIN | - |
dc.subject.keywordPlus | DIAGNOSIS | - |
dc.subject.keywordPlus | KINASE | - |
dc.subject.keywordPlus | SEED | - |
dc.subject.keywordPlus | MAP | - |
dc.subject.keywordAuthor | Alzheimer&apos | - |
dc.subject.keywordAuthor | s disease | - |
dc.subject.keywordAuthor | DHP1401 | - |
dc.subject.keywordAuthor | mild to moderate AD | - |
dc.subject.keywordAuthor | randomized placebo-controlled clinical trial | - |
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