PMID- 34184475 OWN - NLM STAT- MEDLINE DCOM- 20210630 LR - 20220531 IS - 1997-7298 (Print) IS - 1997-7298 (Linking) VI - 121 IP - 5 DP - 2021 TI - [Therapy of moderate cognitive impairment in the early recovery period of ischemic stroke]. PG - 33-39 LID - 10.17116/jnevro202112105133 [doi] AB - OBJECTIVE: To assess the efficacy and safety of prospecta in the treatment of moderate cognitive impairment in the early recovery period of ischemic stroke. MATERIAL AND METHODS: The study included 275 patients (mean age 64.0+/-8.1 years) with a history of single ischemic stroke from 3 to 6 months, with moderate cognitive impairment, and moderate activity in everyday life, who were randomized in two groups. During the screening phase, the severity of cognitive impairment was assessed with the Mini-Mental State Examination and Montreal Cognitive Assessment scales; the level of activity in everyday life was evaluated with the Barthel Scale; and quality of life was assessed with the Stroke Specific Quality of Life Scale. Patients took 2 tablets of prospecta or placebo 2 times a day for 24 weeks. The follow-up period was 4 weeks. The primary endpoint of the study was the proportion of patients with improvement in cognitive function (+1 or more on the MoCA test) after 24 weeks of treatment. The occurrence and type of adverse events (AEs), their severity, relationship to the drug, outcome, changes in vital signs, and the proportion of patients with clinically significant abnormality in laboratory tests were analyzed to assess the safety. RESULTS: A clinically significant improvement in cognitive function was obtained in 91.9% of patients in the prospecta group vs 82.,1% in the placebo group, (p=0.02). There were 57 AEs in 37 (27.4%) Prospecta group patients and 53 AEs in 39 (27.9%) Placebo group participants (p=1.00). No AEs were certainly associated with taking the medication. No clinically significant changes in vital signs or abnormal laboratory results were detected during the study. CONCLUSION: Prospecta is an effective and safe treatment option for patients with moderate cognitive impairment in the early recovery period of ischemic stroke. FAU - Belova, A N AU - Belova AN AUID- ORCID: 0000-0001-9719-6772 AD - Privolzhsky Research Medical University, Nizhniy Novgorod, Russia. FAU - Bogdanov, E I AU - Bogdanov EI AUID- ORCID: 0000-0001-9332-8053 AD - Kazan State Medical University, Kazan, Russia. FAU - Voznyuk, I A AU - Voznyuk IA AUID- ORCID: 0000-0002-0340-4110 AD - Dzhanelidze St. Petersburg Research Institute of Emergency Medicine, St. Petersburg, Russia. FAU - Zhadnov, V A AU - Zhadnov VA AUID- ORCID: 0000-0002-5973-1196 AD - Pavlov Ryazan State Medical University, Ryazan, Russia. FAU - Kamchatnov, P R AU - Kamchatnov PR AUID- ORCID: 0000-0001-6747-3476 AD - Pirogov Russian National Research Medical University, Moscow, Russia. FAU - Kurushina, O V AU - Kurushina OV AUID- ORCID: 0000-0003-4364-0123 AD - Volgograd State Medical University, Volgograd, Russia. FAU - Maslova, N N AU - Maslova NN AUID- ORCID: 0000-0003-0183-5643 AD - Smolensk State Medical University, Smolensk, Russia. LA - rus PT - Journal Article PT - Randomized Controlled Trial TT - Terapiya umerennykh kognitivnykh rasstroistv v rannem vosstanovitel'nom periode ishemicheskogo insul'ta. PL - Russia (Federation) TA - Zh Nevrol Psikhiatr Im S S Korsakova JT - Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova JID - 9712194 SB - IM MH - Aged MH - *Brain Ischemia/complications/drug therapy MH - *Cognitive Dysfunction/drug therapy/etiology MH - Humans MH - *Ischemic Stroke MH - Middle Aged MH - Quality of Life MH - *Stroke/complications/drug therapy OTO - NOTNLM OT - early recovery OT - ischemic stroke OT - moderate cognitive impairment OT - prospecta EDAT- 2021/06/30 06:00 MHDA- 2021/07/01 06:00 CRDT- 2021/06/29 07:04 PHST- 2021/06/29 07:04 [entrez] PHST- 2021/06/30 06:00 [pubmed] PHST- 2021/07/01 06:00 [medline] AID - 10.17116/jnevro202112105133 [doi] PST - ppublish SO - Zh Nevrol Psikhiatr Im S S Korsakova. 2021;121(5):33-39. doi: 10.17116/jnevro202112105133.