Results of multicenter study of efficacy and safety of divaza in the treatment of the asthenic and mild to moderate cognitive disorders in elderly and senile subjects

Parfenov, V. А.; Камчатнов, П Р; Vorobyova, O. V.; Густов, Александр Васильевич; Glushkov, K S; Доронина, О. Б.

doi:10.17116/jnevro20171179143-50

Cited by 5 publications

(8 citation statements)

References 17 publications

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“…Prespeci ed secondary end points: the proportion of patients with a decrease in the total score of the MoCA questionnaire by 1 or more points in the Divaza group will be at least 82%, while in the placebo group, the same indicator will be no more than 50% [29].…”

Section: Discussionmentioning

confidence: 99%

“…The following reaction parameters were analyzed: rapid CL are amplitude (mV) re ecting the level of preformed LPO products (mainly lipid hydroperoxides); duration of CL latent period (seconds) characterizing LP resistance to oxidation, which re ects the level of endogenous antioxidant potential, and the maximum intensity of chemiluminescence (mV) re ecting LP oxidation capacity [29].…”

Section: Sample Handling and Analysismentioning

confidence: 99%

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Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

et al. 2021

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Objective: The objective of this study was to determine if Divaza, a drug with nootropic and antioxidant effects, was safe and effective for the correction of oxidative disturbances and to stabilize cognitive impairment in patients with cerebral atherosclerosis. Study Design: The study design consisted of a 12-week multicenter, randomized, double-blind, placebo-controlled, prospective trial in parallel groups. Setting: The setting in which the study was conducted comprised 10 clinical centers across the Russian Federation. Interventions: Patients were randomized into 2 groups and instructed to take either 2 tablets of the study drug or a placebo 3 times per day in conjunction with basic therapy. Outcomes: The primary outcome was a change in the average endogenous antioxidant potential after the completion of the study. The blood indicators of the oxidative stress (OS) were analyzed at the baseline and then after 12 weeks of therapy using iron-induced chemiluminescence analysis. The Montreal cognitive assessment test was used as a secondary outcome measure to evaluate cognitive impairment at the end of the study. Results: 124 outpatients with a mean age of 60.7 ± 7.6 years were enrolled and randomly assigned to receive Divaza (n = 65) or a placebo (n = 59). An improvement of cognitive function was observed in all patients of the Divaza group at the end of the treatment; this was significantly better than the placebo group (100 [100] vs. 89.5 [89.1]%, respectively, p = 0.0272 [p = 0.0128]). The administration of Divaza restored the activity of the endogenous antioxidant system. The change in the average level of lipoprotein resistance to oxidation after 12 weeks of therapy, compared to the baseline, was significantly higher in the Divaza group (14.8 ± 14.7 [14.8 ± 14.7] seconds latent period vs. 6.4 ± 16.9 [6.9 ± 16.7] seconds in the placebo group (p = 0.007 [p = 0.0107]). Conclusions: Divaza is a safe and effective therapeutic option for attenuating OS and recovery of cognitive impairment in patients with cerebral atherosclerosis.

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Section: Discussionmentioning

confidence: 99%

Section: Sample Handling and Analysismentioning

confidence: 99%

Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

et al. 2021

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“…The study confirmed the high safety profile of Divaza. Previous studies showed the ability of Divaza to improve the health state, the QoL, and sleep pattern of patients with vestibular disorder, asthenic syndrome, and CD [9, 17].…”

Section: Discussionmentioning

confidence: 99%

“…S100B is a protein primarily expressed by astrocytes and involved in regulation of neurogenesis in the developing and adult brain [16]. The combined endothelial protective and nootropic effects of Divaza components cause improvement of cognitive functions in patients with cerebrovascular diseases [9, 17]. Thus, Divaza possesses a polyvalent mechanism of action (affecting the trophic processes, neuroprotection, and neuroplasticity) and has a favorable safety profile, which allows using the medicine in elderly patients [9].…”

Section: Introductionmentioning

confidence: 99%

Treatment of Cognitive Impairment and the Role of Demographic Factors in Disease Progression: The Final Results of the Russian Observational Program “DIAMANT”

et al. 2020

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Background: Chronic cerebral ischemia (CCI) is a form of cerebrovascular disease manifested as a vascular cognitive impairment (VCI). The management of the patients with CCI is determined by a healthy lifestyle and early therapy aimed at correcting and preventing this disease. Divaza is a drug with endothelial protective and nootropic effects. We present the final efficacy and safety analysis of all-Russian, open-label, prospective, observational, multicenter study of Divaza and emphasize the role of demographic and socioeconomic factors in cognitive disorder (CD) progression. Methods: CCI patients (n = 2,583) with or without CD were enrolled. Patients received Divaza (2 tablets 3 times per day for 12 weeks). Montreal Cognitive Assessment (MoCA) testing was required. The change in the mean MoCA score post-treatment was used as the primary endpoint. As the secondary endpoints, the number of patients with a MoCA <26 and ≤17 (dementia); the percentage of patients with a MoCA score improvement in different age groups; the dynamics of mean MoCA score in age groups; and the relationship between CD and sex or regional social/economic factors were assessed. Results: Divaza therapy led to a significant improvement: the mean MoCA score was up to 20% higher post-treatment (Wilcoxon test, p < 0.0001 vs. baseline). The number of participants with MoCA ≥26 increased by 33.6%. The number of patients with dementia was 4.1 times less after therapy (p < 0.00001 vs. baseline). Divaza improved cognitive functions of patients in each age group. Findings demonstrate that regional socioeconomic factors contribute to CD development and severity. The observed divergence between sexes was a result of a larger number of women enrolled. The study confirmed the safety of Divaza. Conclusions: In the study, we observed the efficacy of Divaza for the treatment of CD: a therapy contributed to an increase in the mean MoCA score and the positive dynamics in the number of patients with cognitive improvement.

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“…Neuroprotective action of the combination of RAF Abs to S100 and RAF Abs to eNOS was shown in a trial, conducted by Parfenov et al: a 10% decrease in asthenia severity in 61% of patients, threefold decrease in 25% of patients, and improvement in sleep and quality of life (according to the SF36 questionnaire) were shown 192…”

Section: Treatment Of Vci and Perspectives Of A Novel Preparationmentioning

confidence: 97%

Vascular cognitive impairment: pathophysiological mechanisms, insights into structural basis, and perspectives in specific treatments

Parfenov¹,

Остроумова²,

Остроумова³

et al. 2019

NDT

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Vascular cognitive impairment (VCI) and vascular dementia are the most common forms of cognitive disorder associated with cerebrovascular disease and related to increased morbidity and mortality among the older population. Growing evidence suggests the contribution of blood-pressure variability, cardiac arrhythmia, hyperactivation of the renin–angiotensin–aldosterone system, endothelial dysfunction, vascular remodeling and stiffness, different angiopathies, neural tissue homeostasis, and systemic metabolic disorders to the pathophysiology of VCI. In this review, we focus on factors contributing to cerebrovascular disease, neurovascular unit alterations, and novel approaches to cognitive improvement in patients with cognitive decline. One of the important factors associated with the neuronal causes of VCI is the S100B protein, which can affect the expression of cytokines in the brain, support homeostasis, and regulate processes of differentiation, repair, and apoptosis of the nervous tissue. Since the pathological basis of VCI is complex and diverse, treatment affecting the mechanisms of cognitive disorders should be developed. The prospective role of a novel complex drug consisting of released–active antibodies to S100 and to endothelial NO synthase in VCI treatment is highlighted.

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Results of multicenter study of efficacy and safety of divaza in the treatment of the asthenic and mild to moderate cognitive disorders in elderly and senile subjects

Abstract: The efficacy and safety of divasa in asthenic and mild to moderate cognitive disorders in elderly and senile subjects were shown. There is a need for a multicenter placebo-controlled trial on the efficacy of divasa to treat cognitive and asthenic disorders in elderly patients.

Cited by 5 publications

References 17 publications

Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Efficacy and Safety of Divaza for the Correction of Oxidative Disturbances in Patients with Cerebral Atherosclerosis: A Randomized Controlled Trial

Treatment of Cognitive Impairment and the Role of Demographic Factors in Disease Progression: The Final Results of the Russian Observational Program “DIAMANT”

<p>Vascular cognitive impairment: pathophysiological mechanisms, insights into structural basis, and perspectives in specific treatments</p>

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