Vascular dementia
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical study. Intervention group: 15 participants will receive 2ml (300mg) of cannabidiol per day for 4 weeks. Participants will be evaluated b
Sponsors
Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)
Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Clinical instability; use of warfarin, clobazam, valproic acid, anti-inflammatory or anticancer medications; alcohol use; Delirium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactRebeca Pessoa
Faculdade de Medicina de Ribeirão Preto- Universidade de São Paulo (FMRP-USP)
Outcome results
None listed