Efficacy and Safety of Idebenone Tablets in Patients with Post-Stroke Cognitive Impairment: A Real-World Study

Shao Yanqi¹Xinyu Zhao²Zunchun Xie²You Xie³Shunyuan Guo^1*

• ¹Zhejiang Provincial People's Hospital, Hangzhou, China
• ²First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China
• ³Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital, Jishou, Hunan, China

Objective: To evaluate the efficacy, safety, and adherence of idebenone tablets in improving cognitive function among patients with post-stroke cognitive impairment in a real-world setting. Methods: This single-arm, multicenter, real-world observational study enrolled 3,755 patients with post-stroke cognitive impairment from 342 hospitals across China between January 2020 and December 2024. Patients received idebenone (30 mg three times daily) for three months. Cognitive function was assessed using MoCA and MMSE at baseline and months 1, 2, and 3. Treatment effectiveness was categorized as markedly effective (≥80% improvement), effective (30-79% improvement), or ineffective (<30% improvement). Results: Of the 3,755 patients (mean age 60.7±10.4 years; 58.5% male), 61.8% had hypertension and 48.4% had ischemic stroke. The total effectiveness rate increased progressively from 10.9-13.0% at month 1 to 37.4-38.2% at month 3 for both MoCA and MMSE scores (P<0.001). MoCA scores improved from 14.6±5.1 at baseline to 17.6±6.2 at month 3, while MMSE scores increased from 14.2±4.6 to 17.5±6.2. High medication adherence (≥80%) was achieved by 96.9% of patients. Only mild adverse events were reported in less than 2% of patients, with no severe adverse events documented. Conclusions: This real-world study suggests that three-month idebenone therapy provides meaningful improvements in cognitive function among patients with post-stroke cognitive impairment, with excellent safety and adherence profiles. However, the observational, single-arm design without a control group means that observed improvements cannot be definitively attributed to the intervention alone. Further randomized controlled trials are warranted to confirm these findings and optimize treatment protocols.