Meta-analysis of randomized controlled trials of the effectiveness of Prospekta in the treatment of vascular cognitive impairment of varying severity

Parfenov V.A.; Bogolepova A.N.; Mkhitaryan E.A.

doi:https://doi.org/10.17116/jnevro202412406162

Parfenov V.A.

Sechenov First Moscow State Medical University (Sechenov University)

SPIN RSCI: 3322-5559
Scopus AuthorID: 57216913889
ResearcherID: AAG-7021-2019
ORCID: 0000-0002-1992-7960

Bogolepova A.N.

Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

SPIN RSCI: 6775-0279
Scopus AuthorID: 6602240836
ORCID: 0000-0002-6327-3546

Mkhitaryan E.A.

Pirogov Russian National Research Medical University;
Russian Gerontology Research and Clinical Centre of the Pirogov Russian National Research Medical University

ORCID: 0000-0002-9054-0881

Meta-analysis of randomized controlled trials of the effectiveness of Prospekta in the treatment of vascular cognitive impairment of varying severity

Authors:

Parfenov V.A., Bogolepova A.N., Mkhitaryan E.A.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2024;124(6): 62‑69

DOI: 10.17116/jnevro202412406162

Read: 9513 times

Download PDF (RU)

Contact the author

Table of contents

To cite this article:

Parfenov VA, Bogolepova AN, Mkhitaryan EA. Meta-analysis of randomized controlled trials of the effectiveness of Prospekta in the treatment of vascular cognitive impairment of varying severity. S.S. Korsakov Journal of Neurology and Psychiatry. 2024;124(6):62‑69. (In Russ.)
https://doi.org/10.17116/jnevro202412406162

Подписка 2026 Журнал неврологии и психиатрии им. С.С. Корсакова (S.S. Korsakov Journal of Neurology and Psychiatry)

Использование инфографики авторами научных работ

Close metadata

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 visit» 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 placebo» — 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.

Keywords:

vascular cognitive impairment

mild cognitive impairment

dementia

meta-analysis

Prospekta

Authors:

Parfenov V.A.

Sechenov First Moscow State Medical University (Sechenov University)

SPIN RSCI: 3322-5559
Scopus AuthorID: 57216913889
ResearcherID: AAG-7021-2019
ORCID: 0000-0002-1992-7960

Bogolepova A.N.

Pirogov Russian National Research Medical University;
Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency

SPIN RSCI: 6775-0279
Scopus AuthorID: 6602240836
ORCID: 0000-0002-6327-3546

Mkhitaryan E.A.

Pirogov Russian National Research Medical University;
Russian Gerontology Research and Clinical Centre of the Pirogov Russian National Research Medical University

ORCID: 0000-0002-9054-0881

Received:

16.04.2024

Accepted:

17.04.2024

Close metadata

References:

Nichols E, Steinmetz JD, Vollset SE, et al. Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2022;7(2):e105-125. https://doi.org/10.1016/S2468-2667(21)00249-8
Cao Q, Tan CC, Xu W, et al. The Prevalence of Dementia: A Systematic Review and Meta-Analysis. J Alzheimers Dis. 2020;73(3):1157-1166.
Wolters FJ, Chibnik LB, Waziry R, et al. Twenty-seven-year time trends in dementia incidence in Europe and the United States. Neurology. 2020;95(5):e519-31. https://doi.org/10.1212/WNL.0000000000010022
Wolters FJ, Ikram MA. Epidemiology of Vascular Dementia. Arterioscler Thromb Vasc Biol. 2019;39(8):1542-1549. https://doi.org/10.1161/ATVBAHA.119.311908
Bir SC, Khan MW, Javalkar V, et al. Emerging Concepts in Vascular Dementia: A Review. J Stroke Cerebrovasc Dis. 2021;30(8):105864. https://doi.org/10.1016/j.jstrokecerebrovasdis.2021.105864
Parfenov VA. Poststroke cognitive impairment. Neurology, Neuropsychiatry, Psychosomatics. 2019;11(4):22-27. (In Russ.). https://doi.org/10.14412/2074-2711-2019-4-22-27
Skrobot OA, Attems J, Esiri M, et al. Vascular cognitive impairment neuropathology guidelines (VCING): the contribution of cerebrovascular pathology to cognitive impairment. Brain. 2016;139(11):2957-2969. https://doi.org/10.1093/brain/aww214
Parfenov VA, Kulesh AA. Cerebrovascular disease with neurocognitive impairment. S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(9):121-130. (In Russ.). https://doi.org/10.17116/jnevro2021121091121
Biessels GJ. Diagnosis and treatment of vascular damage in dementia. Biochim Biophys Acta BBA — Mol Basis Dis. 2016;1862(5):869-877. https://doi.org/10.1016/j.bbadis.2015.11.009
Ip BY, Ko H, Lam BYK, et al. Current and Future Treatments of Vascular Cognitive Impairment. Stroke. 2024;55(4):822-839. https://doi.org/10.1161/STROKEAHA.123.044174
Sweeney MD, Montagne A, Sagare AP, et al. Vascular dysfunction — The disregarded partner of Alzheimer’s disease. Alzheimer’s Dement. 2019;15:158-156. https://doi.org/10.1016/j.jalz.2018.07.222
Bogolepova AN, Vasenina EE, Gomzyakova NA, et al. Clinical Guidelines for Cognitive Disorders in Elderly and Older Patients. S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(10-3):6-137. (In Russ.). https://doi.org/10.17116/jnevro20211211036
Kulesh AA, Emelin AYu, Bogolepova AN, et al. Clinical manifestations and issues of diagnosis of chronic cerebrovascular disease (chronic cerebral ischemia) at an early (pre-dementia) stage. Neurology, Neuropsychiatry, Psychosomatics. 2021;13(1):4-12. (In Russ.). https://doi.org/10.14412/2074-2711-2021-1-4-12
Parfenov VA. Management of patients with cognitive impairment. Neurology, Neuropsychiatry, Psychosomatics. 2023;15(1):97-102. (In Russ.). https://doi.org/10.14412/2074-2711-2023-1-97-102
Farooq MU, Min J, Goshgarian C, et al. Pharmacotherapy for Vascular Cognitive Impairment. CNS Drugs. 2017;31(9):759-776. https://doi.org/10.1007/s40263-017-0459-3
Ngandu T, Lehtisalo J, Solomon A, et al. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015;385:2255-2263. https://doi.org/10.1016/S0140-6736(15)60461-5
Komulainen P, Tuomilehto J, Savonen K, et al. Exercise, diet, and cognition in a 4-year randomized controlled trial: Dose-Responses to Exercise Training (DR’s EXTRA). Am J Clin Nutr. 2021;113(6):1428-1439. https://doi.org/10.1093/ajcn/nqab018
Tainta M, Ecay-Torres M, de Arriba M, et al. GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe.; GOIZ ZAINDU study group. Alzheimers Res Ther. 2024;16(1):44. https://doi.org/10.1186/s13195-024-01393-z
Instructions for medical use of the drug Prospekta. State register of medicines. (In Russ.). Available 12/03/2024. https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=13b7d400-1129-44a7-b96a-26dc2e9c2fe0
General pharmacopoeial monograph. Biological medicinal practices tics based on civil engineering fundamentals https://pharmacopoeia.regmed.ru/pharmacopoeia/izdanie-15/1/1-9/biologicheskie-lekarstvennye-preparaty-poluchennye-na-osnove-gradualnoy-tekhnologii/(Accessedat05.26.2024).(InRuss.).
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. PLoS Medicine. 2021;18(3):e1003583. https://doi.org/10.1371/journal.pmed.1003583
Nasreddine ZS, Phillips NA, Bedirian V, et al. The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool For Mild Cognitive Impairment. J Am Ger Soc. 2005;53(4):695-699. https://doi.org/10.1111/j.1532-5415.2005.53221.x
Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898. https://doi.org/10.1136/bmj.l4898
Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928. https://doi.org/10.1136/bmj.d5928
Rebrova OYu, Fedyaeva VK, Khachatryan GR. Adaptation and validation of the questionnaire to assess the risk of systematic errors in randomized controlled trials. Medical Technologies. Evaluation and Selection. 2015;1(19):9-17. (In Russ.).
Belova AN, Bogdanov EI, Voznyuk IA, et al. Therapy of moderate cognitive impairment in the early recovery period of ischemic stroke. S.S. Korsakov Journal of Neurology and Psychiatry. 2021;121(5):33-39. (In Russ.). https://doi.org/10.17116/jnevro202112105133
Tkacheva ON, Mkhitaryan EA, Kolykhalov IV, et al. Treatment of cognitive, behavioral and mental disorders in patients with vascular dementia: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial. S.S. Korsakov Journal of Neurology and Psychiatry. 2023;123(7):41-49. (In Russ.). https://doi.org/10.17116/jnevro202312307141
Khasanova DR, Yakupova AA, Kamchatnov PR, et al. Treatment of cognitive impairment in patients with cerebral infarction in the internal carotid arteries circulation system: results of a multicentre, randomized, double-blind, placebo-controlled clinical trial. Neurology, Neuropsychiatry, Psychosomatics. 2024;16(1):24-32. (In Russ.). https://doi.org/10.14412/2074-2711-2024-1-24-32
Levin OS, Kovalchuk VV, Putilina MV, et al. Therapy of moderate cognitive impairment of various origins in patients with chronic somatic diseases: results of a multicenter open prospective observational program (PARUS). Effective pharmacotherapy. 2022;18(43):78-83. (In Russ.).
Shvartsman GI, Skoromets AA, Zhivolupov SA, et al. Therapy of moderate cognitive impairment and asthenia in patients with cerebrovascular pathology: results of a prospective observational study. S.S. Korsakov Journal of Neurology and Psychiatry. 2022;122(8):88-94. (In Russ.). https://doi.org/10.17116/jnevro202212208188