Parkinson’s UK, the largest charitable funder of Parkinson’s research in Europe, has partnered with investigators at King’s College London to invest £1.2 million in a pioneering Phase II clinical trial investigating the use of cannabidiol (CBD)—a compound found in the cannabis plant—in people with Parkinson’s-related psychosis.

Parkinson’s in the UK

An estimated 145,000 people live with Parkinson’s disease in the UK. Between 50% to 60% of them will be affected by psychosis at some point in their life. Hallucinations occur when individuals see, hear or feel things that are not really there. Delusions involve developing fixed beliefs that are not true. This phase of the disease can represent a frightening situation for all involved.  Anti-psychotic medication sometime is used but can also lead to a worsening of the symptoms and side effects. In the UK, there are no licensed medications for Parkinson’s-related psychosis.

Parkinson’s Virtual Biotech

The first large-scale clinical trial to investigate evidence for the safety and efficacy of CBD to alleviate the symptoms of Parkinson’s-related psychosis, the 3.5 year project is part of “Parkinson’s Virtual Biotech,” led by the Parkinson’s UK.

Parkinson’s Virtual Biotech is the drug development arm of Parkinson’s UK. The mission is to invest more than £4 million annually to fast track projects to rapidly develop and test treatments with potential to transform life for people with Parkinson’s disease.

The Study

The study will start recruitment early in 2020. It will commence with a six-week pilot to assess the safety, tolerability and effectiveness of pharmaceutical-grade CBD in people with Parkinson’s-related psychosis. The investigators will seek to find an optimal dose by administering the CBD orally in capsules at a dose or up to 1,000 mg/day. The study’s second stage will include 120 people with Parkinson’s related psychosis to participate in a 12-week double-blind, placebo controlled study. Investigators will seek to understand the safety and effectiveness of CBD—half the patient group will receive the compound and half a placebo. The investigative team will undertake detailed assessments of psychotic, motor and non-motor symptoms. Brain imaging will be used to investigate CBD effects.

Medicinal Cannabis UK Position

Next month, a final guidance on medicinal cannabis is due to be published in the National Institute for Health and Care Excellence. Dr. Arthur Roach who directs research at Parkinson’s UK noted in their recent press release that if it indeed turns out that CBD is safe and effective then based on a recent survey they carried out they are confident Parkinson’s disease patients in the UK would be interested in such treatments based on survey results.

Lead Research/Investigator

Sagnik Bhattacharya, Professor of Translational Neuroscience and Psychiatry, King’s College London

Dr. Arthur Roach, Director of Research, Parkinson’s UK

Call to Action: Do you have a loved one diagnosed with Parkinson’s disease that is experiencing psychosis? It might make sense to track this study. TrialSite News will, and to receive updates, you can sign up for the Daily Digest as well.

Source: EurekAlert!

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