PMID- 38465812 OWN - NLM STAT- MEDLINE DCOM- 20240312 LR - 20240320 IS - 1997-7298 (Print) IS - 1997-7298 (Linking) VI - 124 IP - 2 DP - 2024 TI - [Multi-center open comparative randomized study of efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs Akatinol Memantine 10 mg (double-doses) in patients with vascular dementia]. PG - 69-77 LID - 10.17116/jnevro202412402169 [doi] AB - OBJECTIVE: Evaluation of the efficacy and safety of the drug Acatinol Memantine, 20 mg (once daily) in comparison with the drug Acatinol Memantine, 10 mg (twice daily) in patients with moderate to moderate severe vascular dementia. MATERIAL AND METHODS: The study included 130 patients aged 50-85 years of both sexes with instrumentally and clinically confirmed vascular dementia. The patients were randomized into 2 groups. Group I consisted of 65 patients receiving Akatinol Memantine, 20 mg once daily, group II - 65 patients receiving Akatinol Memantine, 10 mg twice daily for 24 weeks. Clinical, parametric and statistical research methods were used. The Alzheimer's disease assessment scale, the cognitive subscale (ADAS-cog), the short mental Status Assessment Scale (MMSE) and the general clinical impression scale for patients condition and illness severity (CGI-C and CGI-S) and the Hamilton Depression Rating scale (HAM-D) were used. Adverse events were collected and analyzed. RESULTS: At week 24, both groups showed statistically significant positive change in ADAS-cog total score: in group I the total score was 27.2+/-8.76 points (absolute difference from baseline 3.5 points; p<0.01), and in group II - 26.1+/-7.86 points (absolute difference from baseline 2.5 points; p<0.01) with no statistically significant differences between groups. Evaluation of secondary efficacy criteria (change in ADAS-cog total score at week 12 and MMSE at weeks 4, 12, and 24) also revealed statistically significant benefit in both groups compared to baseline with no significant differences between groups. Statistically significant improvement was noticed on CGI-S and CGI-C scales in both groups. Akatinol Memantine was safe and well tolerated in both groups. CONCLUSION: The study showed no lesser efficacy and safety of Akatinol Memantine, 20 mg (once daily) compared to Akatinol Memantine, 10 mg (twice daily) in patients with moderate and moderately severe vascular dementia. FAU - Gavrilova, S I AU - Gavrilova SI AUID- ORCID: 0000-0001-6683-0240 AD - Mental Health Research Center, Moscow, Russia. FAU - Kolykhalov, I V AU - Kolykhalov IV AUID- ORCID: 0000-0002-2358-1579 AD - Mental Health Research Center, Moscow, Russia. FAU - Mikhaylova, N M AU - Mikhaylova NM AUID- ORCID: 0000-0003-0184-016X AD - Mental Health Research Center, Moscow, Russia. FAU - Ponomareva, E V AU - Ponomareva EV AUID- ORCID: 0000-0002-2835-5706 AD - Mental Health Research Center, Moscow, Russia. FAU - Fedorova, Ya B AU - Fedorova YB AUID- ORCID: 0000-0002-3150-6229 AD - Mental Health Research Center, Moscow, Russia. FAU - Medvedev, V E AU - Medvedev VE AUID- ORCID: 0000-0001-8653-596X AD - Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia. FAU - Frolova, V I AU - Frolova VI AUID- ORCID: 0000-0003-2261-3812 AD - Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia. FAU - Gushanskaya, E V AU - Gushanskaya EV AUID- ORCID: 0000-0001-9866-9746 AD - Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia. FAU - Litvinenko, I V AU - Litvinenko IV AUID- ORCID: 0000-0001-8988-3011 AD - Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation, St. Petersburg, Russia. FAU - Emelin, A Yu AU - Emelin AY AUID- ORCID: 0000-0002-4723-802X AD - Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation, St. Petersburg, Russia. FAU - Lobzin, V Yu AU - Lobzin VY AUID- ORCID: 0000-0003-3109-8795 AD - Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation, St. Petersburg, Russia. FAU - Kashin, A V AU - Kashin AV AUID- ORCID: 0009-0006-0248-6640 AD - Kirov Military Medical Academy of the Ministry of Defense of the Russian Federation, St. Petersburg, Russia. FAU - Tanashyan, M M AU - Tanashyan MM AUID- ORCID: 0000-0002-5883-8119 AD - Research Center of Neurology, Moscow, Russia. FAU - Kachanova, M V AU - Kachanova MV AUID- ORCID: 0009-0003-6249-0447 AD - Merz Pharma LLC, Moscow, Russia. FAU - Knyazev, A V AU - Knyazev AV AUID- ORCID: 0000-0001-9008-4612 AD - Merz Pharma LLC, Moscow, Russia. FAU - Gonik, M I AU - Gonik MI AUID- ORCID: 0000-0002-0605-8057 AD - Merz Pharma LLC, Moscow, Russia. LA - rus PT - English Abstract PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial TT - Mnogotsentrovoe otkrytoe sravnitel'noe randomizirovannoe issledovanie effektivnosti i bezopasnosti primeneniya preparata Akatinol Memantin, 20 mg (odnokratnyi priem) v sravnenii s preparatom Akatinol Memantin, 10 mg (dvukratnyi priem) u patsientov s sosudistoi dementsiei. PL - Russia (Federation) TA - Zh Nevrol Psikhiatr Im S S Korsakova JT - Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova JID - 9712194 RN - W8O17SJF3T (Memantine) SB - IM MH - Female MH - Humans MH - Male MH - Activities of Daily Living MH - *Alzheimer Disease/drug therapy/psychology MH - Cognition MH - *Dementia, Vascular/drug therapy MH - Double-Blind Method MH - Memantine/adverse effects MH - Treatment Outcome MH - Middle Aged MH - Aged MH - Aged, 80 and over OTO - NOTNLM OT - Akatinol Memantine OT - cognitive impairment OT - efficacy OT - vascular dementia EDAT- 2024/03/11 12:43 MHDA- 2024/03/12 06:42 CRDT- 2024/03/11 08:08 PHST- 2024/03/12 06:42 [medline] PHST- 2024/03/11 12:43 [pubmed] PHST- 2024/03/11 08:08 [entrez] AID - 10.17116/jnevro202412402169 [doi] PST - ppublish SO - Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(2):69-77. doi: 10.17116/jnevro202412402169.