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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)

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dc.contributor.authorShim, Y-
dc.contributor.authorHan, HJ-
dc.contributor.authorPark, KW-
dc.contributor.authorKim, BC-
dc.contributor.authorPark, KH-
dc.contributor.authorPark, MY-
dc.contributor.authorKim, HJ-
dc.contributor.authorMoon, SY-
dc.contributor.authorChoi, SH-
dc.contributor.authorPark, KW-
dc.contributor.authorYang, DW-
dc.contributor.authorYoon, SJ-
dc.contributor.authorKim, SY-
dc.contributor.authorYoun, YC-
dc.contributor.authorChoi, H-
dc.contributor.authorYoon, KE-
dc.contributor.authorCho, HJ-
dc.contributor.authorHan, SH-
dc.date.accessioned2023-03-24T06:27:18Z-
dc.date.available2023-03-24T06:27:18Z-
dc.date.issued2022-
dc.identifier.issn1387-2877-
dc.identifier.urihttp://repository.ajou.ac.kr/handle/201003/25187-
dc.description.abstractBACKGROUND: 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 donepezilMethods: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.-
dc.language.isoen-
dc.subject.MESHAlzheimer disease-
dc.subject.MESHclinical trial-
dc.subject.MESHcomplication-
dc.subject.MESHtreatment outcome-
dc.subject.MESHAlzheimer Disease-
dc.subject.MESHCholinesterase Inhibitors-
dc.subject.MESHDonepezil-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHHumans-
dc.subject.MESHTreatment Outcome-
dc.titleA 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.typeArticle-
dc.identifier.pmid35275529-
dc.subject.keywordAlzheimer's disease-
dc.subject.keywordDHP1401-
dc.subject.keywordmild to moderate AD-
dc.subject.keywordrandomized placebo-controlled clinical trial-
dc.contributor.affiliatedAuthorMoon, SY-
dc.type.localJournal Papers-
dc.identifier.doi10.3233/JAD-215277-
dc.citation.titleJournal of Alzheimer's disease : JAD-
dc.citation.volume87-
dc.citation.number1-
dc.citation.date2022-
dc.citation.startPage391-
dc.citation.endPage403-
dc.identifier.bibliographicCitationJournal of Alzheimer's disease : JAD, 87(1). : 391-403, 2022-
dc.embargo.liftdate9999-12-31-
dc.embargo.terms9999-12-31-
dc.identifier.eissn1875-8908-
dc.relation.journalidJ013872877-
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Neurology
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