se of Cannabidiol in the treatment of psychiatric symptoms of Vascular Dementia
- Conditions
- Vascular dementiaC10.228.140.380
- Registration Number
- RBR-686kmpz
- Lead Sponsor
- Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Clinical instability; use of warfarin, clobazam, valproic acid, anti-inflammatory or anticancer medications; alcohol use; Delirium
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome 1: It is expected to find an improvement in the behavioral symptoms of participants using cannabidiol over a period of one month, verified through the neuropsychiatric inventory and the brief psychiatric assessment scale for schizophrenia.;Outcome found 1: An effect of time and group interaction was observed on the score of the brief psychiatric assessment scale for schizophrenia (p < 0.05; ?p2 = 0.13) and the neuropsychiatric inventory (p = 0.05; ?p2 = 0. 11) in participants who used cannabidiol over a period of one month, verified using the mixed ANOVA method with repeated measures, between the pre- and post-intervention periods.
- Secondary Outcome Measures
Name Time Method Expected outcome 2: It is expected to find an improvement in the cognition of participants using cannabidiol over a period of one month, assessed through the mini-mental state exam and the brief cognitive screening battery.;Outcome found 2: No effect of the time and group interaction was observed for the mini-mental state examination (p =0.25; ?p2 = 0.05) and the brief cognitive screening battery (p=0.69; ?p2 = 0.01) in participants who used cannabidiol over a period of one month, verified using the mixed ANOVA method with repeated measures, between the pre- and post-intervention periods.