Efficacy and safety of oxiracetam in patients with vascular cognitive impairment: A multicenter, randomized, double-blinded, placebo-controlled, phase IV clinical trial

Jae Sung Lim, Juneyoung Lee, Yeonwook Kang, Hyun Tae Park, Dong Eog Kim, Jae Kwan Cha, Tai Hwan Park, Jae Hyuk Heo, Kyung Bok Lee, Jong Moo Park, Mi Sun Oh, Eung Gyu Kim, Dae Il Chang, Sung Hyuk Heo, Man Seok Park, Hyun Young Park, Sang Hak Yi, Yeong Bae Lee, Kwang Yeol Park, Soo Joo LeeJae Guk Kim, Jun Lee, Kyung Hee Cho, Joung Ho Rha, Yeong In Kim, Jun Hong Lee, Jay Chol Choi, Kyung Mi Oh, Jee Hyun Kwon, Chulho Kim, Jong Ho Park, Keun Hwa Jung, Sang Min Sung, Jong Won Chung, Yong Seok Lee, Hahn Young Kim, Hyun Ji Cho, Jeong Wook Park, Won Jin Moon, Hee Joon Bae

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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 complained 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 obtained in baseline and 36-week follow-up. Co-primary endpoints are changes in the Mini-Mental State Examination 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 exercise can modify the effects of medication and how cognitive function can be restored. Trial registration http://cris.nih.go.kr (KCT0005137).

Original languageEnglish
Article number107108
JournalContemporary Clinical Trials
Volume126
DOIs
StatePublished - Mar 2023

Keywords

  • Clinical trial
  • Exercise
  • Functional MRI
  • Oxiracetam
  • Stroke
  • Vascular cognitive impairment

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