Detailed Information

Cited 0 time in webofscience Cited 0 time in scopus
Metadata Downloads

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)

Authors
Shim, YongSooHan, Hyun JeongPark, Kyung WonKim, Byeong C.Park, Kee HyungPark, Mee YoungKim, Hee-JinMoon, So YoungChoi, Seong HyePark, Kun WooYang, Dong WonYoon, Soo JinKim, Sang YunYoun, Young ChulChoi, HojinYoon, Koung EunCho, Hyun JuHan, Seol-Heui
Issue Date
2022
Publisher
IOS PRESS
Keywords
Alzheimer' s disease; DHP1401; mild to moderate AD; randomized placebo-controlled clinical trial
Citation
JOURNAL OF ALZHEIMERS DISEASE, v.87, no.1, pp.391 - 403
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF ALZHEIMERS DISEASE
Volume
87
Number
1
Start Page
391
End Page
403
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/142140
DOI
10.3233/JAD-215277
ISSN
1387-2877
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.
Files in This Item
There are no files associated with this item.
Appears in
Collections
College of Medicine > Department of Medical Science > 1. Journal Articles

qrcode

Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.

Related Researcher

Researcher Park, Kun Woo photo

Park, Kun Woo
의과대학 (의학과)
Read more

Altmetrics

Total Views & Downloads

BROWSE