Dementia and Neurocognitive Disorders (대한치매학회지)

Korean Dementia Association (대한치매학회)
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Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon (Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine) ;
  • Seong-Ho Koh (Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine) ;
  • Seong Hye Choi (Department of Neurology, Inha University School of Medicine) ;
  • Jee Hyang Jeong (Department of Neurology, Ewha Womans University College of Medicine) ;
  • Hae Ri Na (Department of Neurology, Bobath Memorial Hospital) ;
  • Chan Nyoung Lee (Department of Neurology, Korea University Anam Hospital) ;
  • YoungSoon Yang (Department of Neurology, Soonchunhyang University Cheonan Hospital) ;
  • Ae Young Lee (Department of Neurology, Chungnam National University Hospital) ;
  • Jae-Hong Lee (Department of Neurology, Asan Medical Center) ;
  • Kyung Won Park (Department of Neurology, Dong-A University Hospital) ;
  • Hyun Jeong Han (Department of Neurology, Myongji Hospital, Hanyang University College of Medicine) ;
  • Byeong C. Kim (Department of Neurology, Chonnam National University Medical School and Hospital) ;
  • Jinse Park (Department of Neurology, Haeundae Paik Hospital, Inje University) ;
  • Jee-Young Lee (Department of Neurology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center) ;
  • Kyu-Yong Lee (Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine) ;
  • Sangjae Kim (Teloid Inc.)
  • Received : 2023.06.15
  • Accepted : 2023.06.22
  • Published : 2023.07.31
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Abstract

Background and Purpose: 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. Methods: We performed a post hoc 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. Results: 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) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

Keywords

Acknowledgement

This research was supported by grants from the Korea Dementia Research Center (KDRC) funded by the Ministry of Health & Welfare and Ministry of Science and ICT, Republic of Korea (HI20C0253, HU21C0113, and HU21C0007), and GemVax & Kael Co., Ltd.

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