Kwon Hyuk Sung, Koh Seong-Ho, Choi Seong Hye, Jeong Jee Hyang, Na Hae Ri, Lee Chan Nyoung, Yang YoungSoon, Lee Ae Young, Lee Jae-Hong, Park Kyung Won, Han Hyun Jeong, Kim Byeong C, Park Jinse, Lee Jee-Young, Lee Kyu-Yong, Kim Sangjae
Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
Department of Translational Medicine, Hanyang University Graduate School of Biomedical Science & Engineering, Seoul, Korea.
Dement Neurocogn Disord. 2023 Jul;22(3):100-108. doi: 10.12779/dnd.2023.22.3.100. Epub 2023 Jul 11.
The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD.
We performed a analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name- were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events.
In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (=0.017 and =0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups.
Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.
GV1001在中重度阿尔茨海默病（AD）患者中的疗效和安全性已得到证实。在本研究中，我们旨在使用严重损害量表（SIB）的子量表进一步证明GV1001的有效性，该量表是评估中重度AD患者认知功能的有效指标。
我们对一项为期6个月、多中心、2期、随机、双盲、安慰剂对照的GV1001试验（ClinicalTrials.gov，NCT03184467）的数据进行了分析。患者被随机分为接受GV1001或安慰剂治疗24周。在本研究中，比较了治疗组（GV1001 1.12mg）和安慰剂组在第12周和第24周时SIB的九个子量表——社交互动、记忆、定向、语言、注意力、运用、视觉空间能力、构建和命名定向。还根据不良事件确定了这些患者的安全终点。
除了GV1001对SIB总分有显著有益影响外，在全分析集（FAS）和符合方案集（PPS）中，与安慰剂相比，1.12mg GV1001在24周时对语言功能的影响最为显著（分别为=0.017和=0.011）。两组不良事件发生率无显著差异。
使用SIB语言子量表测量，接受GV1001治疗的中重度AD患者比接受安慰剂治疗的患者在语言方面获益更大。
