[Treatment of cognitive, behavioral and mental disorders in patients with vascular dementia: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial].
O N Tkacheva, E A Mkhitaryan, I V Kolykhalov, A N Belova, O V Kolokolov, L G Zaslavsky, N M Khasanova, L R Akhmadeeva, E I Bogdanov
{"title":"[Treatment of cognitive, behavioral and mental disorders in patients with vascular dementia: results of a multicenter, randomized, double-blind, placebo-controlled clinical trial].","authors":"O N Tkacheva, E A Mkhitaryan, I V Kolykhalov, A N Belova, O V Kolokolov, L G Zaslavsky, N M Khasanova, L R Akhmadeeva, E I Bogdanov","doi":"10.17116/jnevro202312307141","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Evaluation of the efficacy and safety of Prospect in the treatment of cognitive, behavioral and mental disorders in patients with vascular dementia (VSD).</p><p><strong>Material and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Prospekta is an effective and safe drug for treating cognitive, behavioural and mental disturbances in patients with vascular dementia.</p>","PeriodicalId":24030,"journal":{"name":"Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.17116/jnevro202312307141","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 1
Abstract
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.
目的:评价Prospect治疗血管性痴呆(VSD)患者认知、行为和精神障碍的疗效和安全性。材料和方法:在一项双盲、安慰剂对照、平行组随机临床试验中，纳入406名年龄在60-85岁、诊断为轻度/中度血管性痴呆(Mini-Mental State Examination, MMSE)的患者(10-24分)，无抑郁症状(Cornell Scale for depression In dementia, CSDD)评分≤10分)。就诊1时，收集主诉和病史，记录生命体征，用MMSE和MoCA评估认知功能障碍，完成NPI-C和CSDD，并进行MRI脑扫描。患者随机分为两组:1组患者接受Prospekta治疗，剂量为2片，每天2次，持续24周;2组患者根据研究药物方案接受安慰剂治疗。结果:两组患者在人口学和基线临床特征上无差异。与安慰剂组相比，服用Prospekta 24周可减少血管性痴呆患者的认知障碍。Prospekta组MoCA评分从17.0±3.6[17.1±3.6]上升至20.5±4.7[20.4±4.7]，而安慰剂组MoCA评分从17.3±3.7[17.3±3.8]上升至19.2±4.9[19.2±5.0]。用NPI-C量表测量，用药物治疗也降低了神经精神症状的严重程度。Prospekta组的平均评分从57.0±26.7[56.7±25.4]降至39.8±23.6[39.8±23.5]，安慰剂组从55.5±25.5[55.3±24.4]降至42.8±27.6[42.3±25.3]。Prospekta组和安慰剂组的MoCA和NPI-C平均评分差异有统计学意义。结论:Prospekta是一种安全有效的治疗血管性痴呆患者认知、行为和精神障碍的药物。
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
