A clinical trial evaluating the efficacy and safety of oxiracetam in the treatment of patient with post-stroke cognitive impairment

Objective To assess the efficacy and safety of oxiracetam in the treatment of patients with post-stroke cognitive impairment. Methods In this randomized，double-blind trial，200 patients with post-stroke cognitive impairment were randomized 1∶1 to receive: oxiracetam 800 mg and 4 piracetam simulation tablets three times daily for 6 months，or piracetam 1600 mg and 2 oxiracetam simulation capsules，three times daily for 6 months.These clinical parameters were tested by Montreal Cognitive Assessment (MoCA)，Mini-mental State Examination (MMSE) and Activity of Daily Living Scale (ADL) during a 6-month follow-up period. Results After 6 months of treatment，the MMSE score showed that the oxiracetam-intervention group’s score improved by a mean of 3.24 points，with a total effective rate of 91.6%，which was higher than that of the control group (2.30 points)，and the difference in point change between the 2 groups was statistically significant (t=2.079，P=0.039)，MoCA score showed that the oxiracetam-intervention group’s score improved by a mean of 5.82 points，which was higher than that of the control group (4.76 points).The ADL efficacy analysis showed that the oxiracetam-intervention group’s score decreased by a mean of 6.44 points，which was higher than that of the control group (4.39 points)，and the score ratio change differences between the 2 groups was not statistically significant (t=1.798，P=0.074;t=-1.914，P=0.057).The situation of patients’cognitive impairment got better along with the oxiracetam treatment for 1，2，4，6 months，so was the total effective rate (P<0.01). Conclusions This research proves that oxiracetam has definitely therapeutic effect on patient with post-stroke cognitive impairment.With the extension of treatment time，the situation of patients gets even better.MMSE score shows that oxiracetam has better effect on improving post-stroke cognitive impairment than piracetam，and oxiracetam does not show any serious adverse reactions.Oxiracetam has little adverse reactions and it shows impressive safety. Key words: Stroke; Pyrrolidines; Cognition disorders; Reproducibility of results