A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson’s disease and to understand its mechanism of action
Randomised, double-blind, placebo-controlled crossover Phase II trial (n=34) comparing repeated low oral doses of psilocybin (5 mg) and ketamine (35 mg) versus placebo in people with Parkinson’s disease to assess effects on affect, cognition and biological markers.
Details
This therapeutic exploratory randomised double-blind crossover trial tests repeated low-dose oral psilocybin and ketamine versus placebo in people with Parkinson’s disease to evaluate changes in positive and negative affect and related cognitive and biological outcomes.
Secondary outcomes include well-being, emotional and cognitive attention (computer tasks), neuroplasticity biomarkers, memory and executive function measures, emotion regulation, Parkinson’s symptom severity, microbiome and immune markers, and endocannabinoid concentrations.
Single-site in the Netherlands; participants were adults (including older adults). The primary endpoint is change in affect scores after completing all three treatment conditions.