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临床试验/RBR-686kmpz
RBR-686kmpz进行中(未招募)2 期

Effects of Cannabidiol on behavioral and psychological symptoms of Vascular Dementia

Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)0 个研究点开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
发起方

研究概览

简要总结

Introduction: Vascular dementia (VD) is the second most common cause of dementia and is characterized by cerebrovascular changes generating cognitive impairment. In patients with VI, the Behavioral and Psychological Symptoms of Dementia (BPSD) are heterogeneous and highly prevalent manifestations that can arise during the course of dementia and bring suffering to the individual and their family. Currently, pharmacological interventions in the treatment of these symptoms have important adverse effects. Cannabidiol (CBD) has neuroprotective, anxiolytic and antipsychotic properties, as well as a favorable tolerability and safety profile. Objectives: To evaluate the effect of CBD on behavioral and psychological symptoms in elderly people with VI. Methods: Double-blind, randomized, placebo-controlled clinical study involving elderly people with VI. The instruments used are: Neuropsychiatric Inventory, Brief Psychiatric Rating Scale, Clinical Global Impression Scale, Side Effects Scale, Mini Mental State Examination, Brief Cognitive Screening Battery, Katz Index, Lawton Scale, Informant Questionnaire on Cognitive Decline in the Elderly, Zarit Burden Scale. The included participants were assessed at the beginning of the study (baseline assessment), in the first, second and fourth weeks after the start of the clinical trial. Results: 30 participants were included. The mixed ANOVA with repeated measures showed that there is an effect of the interaction time and group (F(2.12;59.43) = 4.02; p < 0.05; ?p2 = 0.13) on the total score of the brief scale psychiatric assessment and neuropsychiatric inventory (F(1.58;44.31) = 3.61; p =0.05; ?p2 = 0.11). The mixed repeated measures ANOVA showed no effect of the interaction time and group for the mini-mental state examination, brief cognitive screening battery. Conclusion: In this study, cannabidiol reduced psychological and behavioral symptoms in patients with vascular dementia. Future studies with larger samples are needed to confirm the findings.

研究设计

研究类型
Interventional

入排标准

年龄范围
60Y 至 0(—)

入选标准

  • Being 60 years of age or older; both genders; diagnosis of Vascular Dementia; obtain at least 4 points in the Neuropsychiatric Inventory; having a formal or informal caregiver capable of properly informing the patient's status and controlling drug administration; be able to return for reassessments when necessary and have a telephone for daily contacts; stable dose for at least 30 days of psychotropic medications

排除标准

  • Clinical instability; use of warfarin, clobazam, valproic acid, anti-inflammatory or anticancer medications; alcohol use; Delirium

研究者

发起方
Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)

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