The results of an international, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of sequential therapy with Mexidol® and Mexidol® FORTE 250 in patients with chronic cerebral ischemia (the MEMO study), conducted in full compliance with international ethical and scientific standards for the planning and conduct of studies involving human subjects (GCP), were published in the Korsakov Journal of Neurology and Psychiatry, 2021; 121 (11): 7–16. https://doi.org/10.17116/jnevro20211211117, the leading VAK — peer-reviewed publication for neurologists and psychiatrists in Russia.
The MEMO study involved 318 patients with chronic cerebral ischemia (CCI) from 15 clinical centers across Russia and Uzbekistan. Patients in the first group received long-term sequential therapy with Mexidol according to the following regimen: Mexidol®at a dose of 500 mg per day by intravenous drip for 14 days, followed by a switch to Mexidol®FORTE 250 tablets (one 250 mg tablet three times daily) along with background therapy for 8 weeks. The second group of patients received placebo in addition to background therapy, using a similar regimen.
According to the study results, long-term sequential therapy with Mexidol®and Mexidol®FORTE 250 promotes significant regression in the severity of such key CCI manifestations as cognitive, emotional, autonomic, and motor impairments. The simultaneous significant regression of all major clinical manifestations of CCI is a strong argument that Mexidol therapy addresses the underlying pathogenesis of chronic cerebrovascular disease, beyond symptomatic improvement.
Thus, in the Mexidol group, a reliable improvement and normalization of cognitive functions by the end of therapy (day 75): +4.22 points on the MoCA scale with a total score of 26.22 - NORMAL (vs. 2.17 points in the Placebo group and a total score of 24.17 - cognitive impairment) and +8 points on the digital symbol substitution test (vs. +5 points in the Placebo group), which indicates the high effectiveness of Mexidol in relation to the main symptom of CCI - cognitive impairment.
When assessing the severity of asthenic states, a reliable decrease in asthenia in patients of group 1 (Mexidol) was revealed at the end of therapy: -8,33.4 ± 12.68 points on the MFI -20 scale (VS -4.8 ± 11.42 points in the group Placebo). When assessing the condition on the Bek depression scale, a reliable decrease in anxiety levels in patients of the group 1 (Mexidol) by the end of therapy (75th day): -3.00 points on the Bek scale (VS -1.00 points in the placebo group) was also noted .
Long-term sequential therapy with Mexidol® and Mexidol® FORTE 250 also contributed to a significant reduction in the level of vegetative manifestations and balance disorders, walking in patients by the end of therapy (75th day): -5.00 points on the Wein scale (vs -2.00 points in the Placebo group) and +3.00 points on the Tinetti scale (vs +1.00 points in the Placebo group).
A significant improvement in the quality of life in patients of group 1 (Mexidol) was noted by the end of therapy (75th day) as patients: +5.00 points for the SF-36 questionnaire (VS +1.00 point in the placebo group), and attending doctors - More than 53% of patients noted a “strong or tangible improvement” on the scale of the general clinical impression of CGI (VS 14.84% in the placebo + group in 48.4% of the Placebo group “The condition has not changed/worsened”)
The safety of long-term sequential therapy with Mexidol® and Mexidol® FORTE 250 in patients with CCI has been proven.
The growing dynamics of positive changes was noted in the condition of patients of the group 1 (Mexidol), which reaches the maximum of effectiveness to the end of a long consistent therapy (i.e. on the 75th day), which once again proves the importance of a full course of therapy.
Thus, prolonged sequential therapy with Mexidol is a proven effective means of pathogenetic therapy of cognitive, emotional, autonomic and motor disorders in patients with chronic brain ischemia.
Fedin A.I., Zakharov V.V., Tanashyan M.M., Chukanova E.I., Madzhidova E.N., Shchepankevich L.A., Ostroumova O.D. Results of an international multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of sequential therapy of patients with chronic cerebral ischemia with Mexidol and Mexidol FORTE 250 (the MEMO study). Korsakov Journal of Neurology and Psychiatry. 2021; 121(11): 7–16. https://doi.org/10.17116/jnevro20211211117
