[Meta-analysis of randomized controlled trials of the effectiveness of Prospekta in the treatment of vascular cognitive impairment of varying severity]. / Metaanaliz randomizirovannykh kontroliruemykh issledovanii effektivnosti preparata Prospekta v terapii sosudistykh kognitivnykh narushenii raznoi stepeni vyrazhennosti.

OBJECTIVE: To conduct a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of Prospekta in the treatment of SCI of varying severity. MATERIAL AND METHODS: The meta-analysis included the results of RCTs of the efficacy of Prospekta in the treatment of VCI, the severity of which was assessed using the Montreal Cognitive Scale (MoCA). The pooled effect estimate included all publications of double-blind, placebo-controlled RCTs that provided sufficient MoCA efficacy data to support further statistical analysis. The main result of the meta-analysis was obtained for the final values of the efficacy indicator in the groups of patients receiving the drug Prospekta, in comparison with the placebo group. RESULTS: A meta-analysis of the effectiveness of Prospekta in the treatment of SCI of varying severity was carried out based on data from 3 RCTs and 2 CTs involving 12.701 patients aged 18 years and older. When using the mixed models method, the effect size for the endpoint «change in total MoCA score from baseline to follow-up visit¼ was 3.4 points for Prospekta (2.7 points for placebo, p<0.0001); for the end point «∆ between changes in the total score on the MoCA scale while taking Prospekta and placebo¼ - 0.6736 points (p<0.0001). CONCLUSION: A statistically significant improvement in cognitive function according to the MoCA scale was demonstrated in patients with VCI using the drug Prospekta.

[Cognitive impairment in cerebrovascular diseases]. / Kognitivnye narusheniya pri sosudistykh zabolevaniyakh golovnogo mozga.

Cognitive impairment, which is highly prevalent, especially among older people, leads to a decrease in the quality of life of patients, impairment of daily activities, and an increased risk of dementia and mortality. Currently, much attention is paid to mild cognitive impairment. The article discusses diagnostic criteria and possible clinical variants of this syndrome. Given the high rate of progression of mild cognitive impairment to dementia, it is necessary to identify risk groups and carry out therapeutic preventive measures. Correction of potentially modifiable risk factors is considered as a promising direction of therapy. Sufficient physical and mental activity, proper diet, normalization of sleep, visual acuity and hearing are necessary. Preventing stroke and controlling vascular risk factors may reduce the risk of mild cognitive impairment progressing to dementia.

[Cerebral amyloid angiopathy]. / Tserebral'naya amiloidnaya angiopatiya.

Cerebral amyloid angiopathy (CAA) is a progressive disease characterized by the deposition of ß-amyloid in the walls of blood vessels in the brain, which leads to their damage and disruption of normal blood flow. Morphologically, CAA is characterized by both isolated lesions (microhemorrhages with the appearance of cortical superficial siderosis, lacunar infarctions) and widespread changes (hyperintensity of the deep and periventricular white matter, expansion of the perivascular spaces) of cortical and subcortical localization. CAA is considered a major cause of cognitive impairment and intracerebral microbleeds, especially in patients with Alzheimer's disease. The review presents modern ideas about the etiology, pathogenesis, clinical manifestations of CAA, and also outlines the provisions of the Boston principles of CAA, revised in 2022. Understanding the features of pathogenetic methods of CAA is crucial for adjusting the accuracy of diagnosis and developing treatment methods to preserve and prolong cognitive health.

[Attention deficit hyperactivity disorder in children and adolescents: lessons from the COVID-19 pandemic]. / Sindrom defitsita vnimaniya i giperaktivnosti u detei i podrostkov: uroki pandemii COVID-19.

To limit the spread of the coronavirus infection COVID-19, which has received the status of a pandemic, a lockdown was temporarily introduced. In conditions of isolation, children and adolescents suffering from attention deficit hyperactivity disorder (ADHD) were faced with forced changes in their daily routine in the form of a transition to distance learning, a decrease in physical activity, an increase in time in front of TV screens/computer monitors/tablets, etc. The review provides current evidence on the associations between social restrictions caused by the COVID-19 pandemic and behavioral problems in children and adolescents with ADHD. The main factors that can influence the severity of the disease in children and adolescents are analyzed. Particular attention is paid to the role of parental behavior and its influence on the manifestations of ADHD in children in isolation. The results of numerous observations and online surveys of relatives and children suffering from ADHD have demonstrated a multidirectional trajectory of the disease depending on numerous factors, including relationships with parents and immediate family. Despite the end of the COVID-19 pandemic, the effects of isolation during critical periods of childhood have the potential to increase the burden of mental illness. Treatment of children and adolescents with ADHD during the COVID-19 pandemic should be pathogenetic, taking into account the main symptoms of the disease. When choosing pharmacotherapy, priority should be given to drugs with verified effectiveness and a reliable safety profile.

[The problem of comorbid disorders in attention deficit hyperactivity disorder in children and adolescents: clinical cases]. / Problema komorbidnykh rasstroistv pri sindrome defitsita vnimaniya s giperaktivnost'yu u detei i podrostkov i ikh korrektsiya: klinicheskie nablyudeniya.

The problem of comorbid disorders in attention deficit hyperactivity disorder (ADHD) is considered, which occur in at least 60% of patients and lead to additional difficulties in intra-family, school and social adaptation. Children and adolescents with ADHD have a wide range of neurological and somatic disorders caused by complex polygenic pathogenetic mechanisms. Among the pathologies associated with ADHD in this cohort of children, neurotic and anxiety manifestations, motor disorders: dyspraxia, discoordination, impaired gross and fine motor skills, tics, behavioral disorders, enuresis, tension cephalgia are common disorders. Treatment of ADHD should be pathogenetic, taking into account the main symptoms of ADHD and manifestations of comorbid disorders, since it is quite long. When choosing pharmacotherapy, it is preferable to use drugs with verified efficacy not only in the correction of ADHD, but also concomitant behavioral, motor and emotional disorders. Also an important aspect in the pediatric clinic is the use of drugs with a reliable safety profile.

[Therapy of asthenic disorders after psychotic conditions in patients with cognitive impairment: results of an observational non-interventional program]. / Terapiya astenicheskikh rasstroistv posle perenesennykh psikhoticheskikh sostoyanii u patsientov s kognitivnymi narusheniyami: rezul'taty nablyudatel'noi neinterventsionnoi programmy.

OBJECTIVE: An observational non-interventional study was conducted to obtain data on the efficacy and safety of Prospekta in the treatment of postpsychotic asthenia in patients with cognitive impairment (CI). MATERIAL AND METHODS: We selected 69 patients aged 18-75 years with asthenic disorders that developed after suffering psychotic conditions and CI, who were prescribed Prospekta. At four visits (at baseline, after 2, 4 and 8 weeks), the doctor collected complaints, anamnesis, examined the patient, assessed the severity of asthenia on the MFI-20 (The Multidimensional Fatigue Inventory-20) scale, CI - on the MMSE (The Mini-mental state examination). Concomitant diseases and maintenance therapy of the underlying disease were recorded, and the safety of treatment with Prospect was evaluated. At the last visit, the doctor's clinical impression was assessed using the CGI-I (Clinical Global Impression - Global Improvement Scale). RESULTS: The analysis included data from 69 patients (mean age 45.7 years), of which 27 (33.4%) were women. Prospekta reduced the severity of asthenia on the MFI-20 scale from 85.7±6.6 to 51.6±7.1 points, including general asthenia, mental and physical asthenia, and contributed to an increase in activity and motivation (p<0.001). 8-week treatment with Prospekta improved cognitive function on the MMSE scale from 25.7±3.7 to 28.8±1.5 points (p<0.001). There was no effect of the drug on blood pressure, heart rate. 76 adverse events (AEs) were detected in 22 patients, of which 62 AEs (82%) were of mild severity, 14 AEs (18%) were of moderate severity. A causal relationship of AEs with taking Prospekta, according to doctors, was absent in 48 (63%) cases. CONCLUSION: Prospekta is an effective and safe drug for the treatment of asthenic disorders that have developed after suffering psychotic conditions in patients with CI.

[Treatment of cognitive, behavioral and mental disorders in patients with vascular dementia: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial]. / Lechenie kognitivnykh, povedencheskikh i psikhicheskikh narushenii u patsientov s sosudistoi dementsiei: rezul'taty mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo klinicheskogo issledovaniya.

OBJECTIVE: Evaluation of the efficacy and safety of Prospect in the treatment of cognitive, behavioral and mental disorders in patients with vascular dementia (VSD). MATERIAL AND METHODS: In a double-blind, placebo-controlled, parallel-group randomised clinical trial, 406 patients aged 60-85 years old with a diagnosis of mild/moderate vascular dementia (10-24 on the Mini-Mental State Examination (MMSE)) and without signs of depression (Cornell Scale for Depression in Dementia (CSDD) scores ≤10) were included. At Visit 1, complaints and medical history were collected, vital signs were recorded, cognitive impairment was assessed using MMSE and MoCA, NPI-C and CSDD were completed, and an MRI brain scan was performed. Patients were randomised into two groups: patients in group 1 received Prospekta in a dosage of 2 tablets two times a day for 24 weeks, and patients in group 2 received Placebo according to the study drug regimen. RESULTS: Patients in both groups had no differences in demographic and baseline clinical characteristics. Administration of Prospekta for 24 weeks reduced cognitive impairment in patients with vascular dementia compared to the placebo group. The mean MoCA score increased from 17.0±3.6 [17.1±3.6] to 20.5±4.7 [20.4±4.7] in patients treated with Prospekta, whereas it increased from 17.3±3.7 [17.3±3.8] to 19.2±4.9 [19.2±5.0] in the Placebo group. Treatment with the medication also reduced the severity of neuropsychiatric symptoms as measured by the NPI-C scale. The mean score on this scale decreased from 57.0±26.7 [56.7±25.4] to 39.8±23.6 [39.8±23.5] in the Prospekta group and from 55.5±25.5 [55.3±24.4] to 42.8±27.6 [42.3±25.3] in the Placebo group. The difference in mean MoCA and NPI-C scores between the Prospekta and Placebo groups was statistically significant. CONCLUSION: Prospekta is an effective and safe drug for treating cognitive, behavioural and mental disturbances in patients with vascular dementia.

Efficacy of the Technologically Processed Antibodies to the Brain-Specific S100 Protein in a Rat Model of Hemorrhagic Stroke.

We studied the ability of technologically processed antibodies to the brain-specific S100 protein (drug Prospekta) to reduce the brain lesion area, neurological disorders, and mortality in a rat model of hemorrhagic stroke. Technologically processed antibodies to S100 exerted a positive effect on all these parameters (brain lesion area, survival rate, neurological status according to the Menzies scale, and proportion of contralateral turns). This allows us to recommend further research into the spectrum of pharmacological activity and the mechanism of action of technologically processed antibodies to S100 in order to expand the indications for their use after the necessary clinical trials.

[Imaging of brain activity using fMRI in a patient with subjective cognitive decline]. / Vizualizatsiya mozgovoi aktivnosti s pomoshch'yu fMRT u patsientki s sub"ektivnym kognitivnym snizheniem.

In clinical practice, subjective cognitive decline (SCD) is often difficult to diagnose because it is not detected by standard neuropsychological and cognitive tests.The described clinical case is presented to demonstrate the difficulties of diagnosis and treatment choice in a patient with SCD. fMRI might be considered as an instrumental method to analyze the functional relationship between the activity of brain structures and cerebral circulation in patients with SCD. Patient clinical and neuropsychological data with a detailed description of fMRI with a cognitive paradigm are presented. The article is focused on the early diagnosis of SCD and the prognostic assessment of the transition of SCD to dementia.

Nootropic Activity of Prospekta in a Blind Placebo-Controlled Study in a Model of Focal Cerebral Ischemia in Rats.

Analysis of the pharmacological activity of the original drug Prospekta in a rat model of focal cerebral ischemia revealed its nootropic effect: course treatment in the post-ischemic period led to recovery of the neurological status of animals at the peak of neurological deficit. Evaluation of the therapeutic potential of the drug in morphological and functional CNS disorders allowed us to conclude that it is advisable to carry out further studies of its biological activity at the preclinical stage (the results obtained in animals were successfully confirmed in a clinical trial of drug efficacy in the treatment of moderate cognitive disorders in the early recovery period after ischemic stroke). Studies of the nootropic activity in other pathologies of the nervous system are also promising.

Safety of the Drug Prospekta: a Preclinical Study of Acute and Repeated Dose Toxicity.

General toxic effect of the drug Prospekta (modified affinity purified antibodies to the brain-specific S100 protein) was studied on mature male and female mice and rats: acute toxicity with double intragastric and intraperitoneal administration of the maximum permissible doses at a 2-h interval, repeated dose toxicity with intragastric administration of the maximum permissible and close to therapeutic doses for 6 months. No lethal and toxic effects on animals were observed, including no toxic effects on vital systems, i.e., CNS and cardiovascular system, as well systems with the functions that may be temporarily disrupted (excretory and digestive systems). All the differences between animals of the experimental and control groups varied within the physiological range. It can be concluded that the drug produces no general toxic effect on laboratory animals.

[Treatment of attention deficit hyperactivity disorder in children: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial]. / Terapiya sindroma defitsita vnimaniya s giperaktivnost'yu u detei: rezul'taty mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo klinicheskogo issledovaniya.

OBJECTIVE: Evaluation of the efficacy and safety of the new drug Prospekta in the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 7-12 years. MATERIAL AND METHODS: A multicenter (35 clinical centres) double-blind, placebo-controlled, randomized, parallel-group clinical trial enrolled 363 patients. The mean age was 9.3±1.7 years. Children of both sexes aged between 7 and 12 years with a diagnosis of ADHD confirmed by DSM-V diagnostic criteria were included in the study. Patients with a total score of 22 or more on the Attention Deficit Hyperactivity Disorder-Rating Scale-V (ADHD-RS-V) were included in the study. After randomisation, patients in group 1 received Prospekta, 1 tablet twice daily; patients in group 2 received placebo according to the study drug regimen. The primary efficacy criterion was the proportion of patients with a 25% or greater reduction in the overall ADHD-RS-V scale score after 8 weeks of treatment. As additional criteria for efficacy assessment were assessed: change of ADHD-RS-V total score from baseline after 8 weeks of treatment; Clinical Global Impression Efficacy Index (CGI-EI) score after 8 weeks of treatment; side effects. RESULTS: The proportion of patients with a 25% or more reduction in the ADHD-RS-V scale score after 8 weeks of treatment was 55.9% in the Prospekta group, and 43.3% in the placebo group (p=0.0199). There was a reduction of ADHD symptoms in the Prospekta group as a mean ADHD-RS-V score decreased by 10.2±7.7 (in the placebo group by 8.1±7.9); the difference between the mean ADHD-RS-V score reduction during Prospekta and placebo treatment was 2.09±7.81 (p=0.0096). Mean CGI-EI scores calculated on the basis of physician scores were different in the Prospekta group compared to the placebo group at 6.9±3.2 versus 8.0±3.1 (p=0.0012), indicating greater clinical efficacy of the study drug. The frequency of adverse events (AEs) did not differ significantly between the groups. There were a total of 66 AEs in 46 patients, including 31 AEs in 23 (13.2%) Prospekta group participants and 35 AEs in 23 (12.2%) placebo group participants (p=0.87). No cases of serious AEs were reported during the study. Prospekta is compatible with drugs used in pediatric practice. Prospekta did not cause an exciting effect and did not adversely affect the sleep of patients. CONCLUSION: The drug Prospekta is an effective and safe treatment for ADHD in patients 7-12 years old.

[Therapy of moderate cognitive impairment and asthenia in patients with cerebrovascular pathology: results of a prospective observational study]. / Terapiya umerennykh kognitivnykh narushenii i astenii u patsientov s tserebrovaskulyarnoi patologiei: rezul'taty mnogotsentrovoi otkrytoi prospektivnoi nablyudatel'noi programmy.

OBJECTIVE: Obtaining additional data on the efficacy and safety of the drug Prospekta in the treatment of moderate cognitive impairment (MCI) and asthenia in patients with cerebrovascular disease (CVD). MATERIAL AND METHODS: A prospective observational study in more than 40 Russian cities enrolled 232 patients (mean age 61.5±10.0 years) with mild cognitive impairment (MCI), asthenia on ongoing basic nootropic therapy. The presence of MCI was confirmed by the Montreal Cognitive Assessment Scale (MoCA), asthenia - by 10-point Visual Analog Scale (VAS). All patients were prescribed the nootropic medication Prospekta 2 tablets 2 times a day for 8 weeks in addition to the therapy they received. Ultrasound Doppler sonography of the main arteries of the head and magnetic resonance imaging (MRI) of the brain were also assessed. At the end of treatment, the Clinical Global Impression Efficacy Index (CGI-EI) was assessed and the safety of the treatment was evaluated. RESULTS: The baseline severity of cognitive impairment according to the MoCA scale was 21.6 points, severity of asthenia according to the VAS was 6.3 points. According to Doppler flowmetry findings, hemodynamically significant stenosis was revealed in 105 (49.3%) patients, and narrowing of the main vessels without changes in hemodynamic parameters was revealed in 108 (50.7%) patients. According to MRI results, single vascular lesions in the brain matter were detected in 102 (44.0%) patients. The medications with nootropic effect were administered to 144 (62.1%) patients. A positive therapeutic response as improvement of cognitive functions was seen in 93.3% of patients after 8 weeks of taking Prospekta, including 39.4% of patients who had cognitive functions restored to the normal level. No side effects were registered during the observational study. CONCLUSIONS: The nootropic medication Prospekta is effective and safe in treatment of MCI in patients with asthenia with CVD, and improves cognitive function in patients with asthenia with CVD, both in monotherapy and in combination with other nootropic agents.