Article
作者: Rha, Joung-Ho ; Choi, Jay Chol ; Chang, Dae-Il ; Park, Hyun-Young ; Kim, Chulho ; Oh, Kyungmi ; Park, Jong-Ho ; Yi, Sanghak ; Lee, Jun Hong ; Chung, Jong-Won ; Heo, Jae-Hyeok ; Jung, Keun-Hwa ; Cho, Kyung-Hee ; Park, Tai Hwan ; Park, Man-Seok ; Lee, Juneyoung ; Kim, Dong-Eog ; Bae, Seongryu ; Kim, Hahn Young ; Park, Kwang-Yeol ; Lim, Jae-Sung ; Park, Jong-Moo ; Lee, Yeong Bae ; Lee, Byung-Chul ; Lee, Kyungbok ; Moon, Won-Jin ; Kim, Jae Guk ; Kang, Kyusik ; Oh, Mi Sun ; Park, Hyuntae ; Bae, Hee-Joon ; Cha, Jae-Kwan ; Kim, Eung-Gyu ; Heo, Sung Hyuk ; Lee, Soo Joo ; Kwon, Jee-Hyun ; Jung, Hannah ; Kang, Yeonwook
Introduction:This multicenter, double-blind, placebo-controlled trial, commissioned by South Korea’s Ministry of Food and Drug Safety, evaluated the effect of oxiracetam for preventing post-stroke cognitive impairment (PSCI) and explored potential interaction with physical activity using neuroimaging.
Patients and methods:Patients at high risk of PSCI, reporting subjective cognitive decline ⩾3 months after stroke, were randomized 1:1 to receive oxiracetam or placebo for 36 weeks. Physical activity was tracked via wrist-worn actigraphy. Coprimary endpoints were changes in Mini-Mental State Examination (MMSE) and Clinical Dementia Rating–Sum of Boxes (CDR-SB). Secondary outcomes included neuropsychological assessments and resting-state functional magnetic resonance imaging network metrics.
Results:Of 500 enrolled participants (mean age 68.9 years; median 32 months post-stroke), 457 completed the study. There were no statistically significant differences between groups in changes in MMSE (oxiracetam: +0.13 ± 2.27 vs placebo: +0.27 ± 2.09; p = 0.49) or CDR-SB scores (–0.14 ± 0.70 vs −0.08 ± 0.80; p = 0.38). No evidence of interaction was observed between oxiracetam and physical activity. Exploratory analyses suggested favorable trends in functional segregation and CDR-SB scores among highly active oxiracetam participants.
Discussion and conclusion:Oxiracetam did not demonstrate benefit in preventing PSCI in high-risk patients. These findings support the recent regulatory decision to suspend its use in South Korea.