Efficacy and safety of oxiracetam in patients with vascular cognitive impairment: A multicenter, randomized, double-blinded, placebo-controlled, phase IV clinical trial
- Authors
- Lim, Jae -Sung; Lee, Juneyoung; Kang, Yeonwook; Park, Hyun-Tae; Kim, Dong-Eog; Cha, Jae-Kwan; Park, Tai Hwan; Heo, Jae-Hyuk; Lee, Kyung Bok; Park, Jong -Moo; Oh, Mi Sun; Kim, Eung-Gyu; Chang, Dae-Il; Heo, Sung Hyuk; Park, Man-Seok; Park, HyunYoung; Yi, SangHak; Lee, Yeong Bae; Park, Kwang-Yeol; Lee, Soo Joo; Kim, Jae Guk; Lee, Jun; Cho, Kyung-Hee; Rha, Joung-Ho; Kim, Yeong-In; Lee, Jun Hong; Choi, Jay Chol; Oh, Kyung-Mi; Kwon, Jee-Hyun; Kim, Chulho; Park, Jong-Ho; Jung, Keun-Hwa; Sung, Sang Min; Chung, Jong-Won; Lee, Yong-Seok; Kim, Hahn Young; Cho, Hyun-Ji; Park, Jeong Wook; Moon, Won-Jin; Bae, Hee-Joon
- Issue Date
- Mar-2023
- Publisher
- ELSEVIER SCIENCE INC
- Keywords
- Vascular cognitive impairment; Stroke; Oxiracetam; Exercise; Functional MRI; Clinical trial
- Citation
- CONTEMPORARY CLINICAL TRIALS, v.126
- Journal Title
- CONTEMPORARY CLINICAL TRIALS
- Volume
- 126
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/87099
- DOI
- 10.1016/j.cct.2023.107108
- ISSN
- 1551-7144
- Abstract
- Background: Oxiracetam may have a modest effect on preventing cognitive decline. Exercise can also enhance cognitive function. This trial aims to investigate the effect of oxiracetam on post-stroke cognitive impairment and explore whether this effect is modified by exercise. Furthermore, the mechanisms that mediate this effect will be investigated through a neural network analysis.Methods: This is a multicenter, randomized, double-blind, placebo-controlled phase IV trial. Patients who com-plained of cognitive decline 3 months after stroke and had a high risk of cognitive decline were eligible. Patients were randomly assigned to receive either 800 mg of oxiracetam or placebo twice daily for 36 weeks. After randomization, a predetermined exercise protocol was provided to each participant, and the degree of physical activity was assessed using wrist actigraphy at 4, 12, 24, and 36 weeks. Resting-state functional MRI was ob-tained in baseline and 36-week follow-up. Co-primary endpoints are changes in the Mini-Mental State Exami-nation and Clinical Dementia Rating-Sum of Boxes. Secondary endpoints include changes in the NINDS-CSN VCIHS-Neuropsychology Protocol, Euro QoL, patient's global assessment, and functional network connectivity. If there is a significant difference in physical activity between the two groups, the interaction effect between physical activity and the treatment group will be examined. A total of 500 patients were enrolled from February 2018, and the last patient's final follow-up was completed in September 2022.Conclusion: This trial is meaningful not only to prove the efficacy of oxiracetam, but also evaluate whether ex-ercise can modify the effects of medication and how cognitive function can be restored. Trial registration http://cris.nih.go.kr (KCT0005137).
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