A £1.2 million phase II trial is to begin early next year into the effectiveness of cannabidiol in people with Parkinson’s-related psychosis.
Parkinson’s UK, the largest charitable funder of Parkinson’s research in Europe, is to begin the first large-scale pioneering clinical trial with King’s College London, which will provide preliminary evidence regarding CBD to alleviate the symptoms.
The three-and-a-half-year project is part of the Parkinson’s Virtual Biotech is being carried out because between 50-60% of with the disease are affected by psychosis.
These symptoms are managed with the removal of medication used to treat Parkinson’s and if the symptoms persist, antipsychotic drugs can be used. However, this can worsen motor symptoms and side effects.
The study, which will begin to recruit participants early next year, will start with a six-week pilot to assess the safety, tolerability and effectiveness of pharmaceutical-grade CBD in people with Parkinson’s-related psychosis.
CBD will be delivered orally in capsules at a dose of up to 1,000 mg/day. In the second stage, 120 people with Parkinson’s-related psychosis will be recruited to take part in a 12-week double-blind, placebo-controlled study.
As part of the assessment, scientists will use brain imaging to investigate the effects of CBD.
Dr Arthur Roach, director of research at Parkinson’s UK, said: “We know from a recent survey we carried out, that people with Parkinson’s would continue to use, or start using, cannabis-derived products if robust evidence became available that they are safe and effective in treating Parkinson’s symptoms. One of the key questions this clinical trial will address is if CBD is safe to use for Parkinson’s-related psychosis, which has never been done before.
“This trial will provide evidence of the value of CBD to treat the symptoms of hallucinations and delusions in people with Parkinson’s. This could result in a regulated cannabinoid-based medicine being prescribed and used in the clinic, as opposed to self-administration of expensive supplements that have not been monitored for their composition or effects.”
Lead researcher Professor Sagnik Bhattacharyya, professor of translational neuroscience and psychiatry at King’s College London, said: “Through funding from the Parkinson’s Virtual Biotech this clinical trial will determine, for the first time, whether CBD can correct the abnormal functioning of the brain that is causing symptoms such as hallucinations and delusions.
“We will be assessing how safe CBD is for people with Parkinson’s, what the correct dosage is and how it is tolerated alongside the different medications someone with the condition may already be on. The study will also look at the effect of CBD on other symptoms, which will pave the way for scientists to investigate the potential of the compound in treating these in future studies. We hope that this will progress to large-scale clinical trials – the final step towards becoming a new treatment that will improve the lives of people with Parkinson’s.”
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