Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Delta 9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms

Objective: Present cognitive safety data from study of an oral high-dose cannabidiol (CBD; 100 mg) and low-dose Delta 9-tetrahydocannabinol (THC; 3.3 mg) drug in PD. Methods: Randomized, double- blind, parallel-group, placebo-controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1-1 1/2 hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected. Results: When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group. Conclusion: Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/ short-term use in PD. (c) 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Automated summary

This study presents cognitive safety data from a study on an orally administered high-dose cannabidiol (CBD; 100 mg) and low-dose Delta 9-tetrahydrocannabinol (THC; 3.3 mg) drug in patients with Parkinson's disease. The results indicate that the CBD/THC drug has a small detrimental effect on cognition following acute/short-term use, as evidenced by worse performance on the Animal Verbal Fluency test and higher incidence of adverse cognitive events compared to the placebo group.