CAN-PDP MRI control study

• Research type

  Research Study

• Full title

  CAN-PDP mechanistic MRI Control Study

• IRAS ID

  282088

• Contact name

  Sagnik Bhattacharyya

• Contact email

  sagnik.2.bhattacharyya@kcl.ac.uk

• Sponsor organisation

  King's College London

• Duration of Study in the UK

  1 years, 11 months, 28 days

• Research summary

  Parkinson's disease psychosis is a symptom of Parkinson's disease that causes patients to experience hallucinations and/or delusions. More than half of all patients with Parkinson's disease eventually develop these symptoms over the course of their disease. These problems can be difficult to manage and can impact quality of life. Currently, existing medications to treat these symptoms are either not very effective or have significant side effects.

  In the main clinical trial , Cannabidiol for Parkinson’s Disease Psychosis (CAN-PDP), we aim to test an investigational medicine called cannabidiol (CBD). The purpose of this trial is to look at how safe and well CBD works in patients with Parkinson’s disease psychosis, and how well it is tolerated.

  Another important aspect of the CAN-PDP trial will be to investigate the effect of CBD on the brain function of Parkinson’s patients with psychosis. To do this, we would like to compare the brains of people from the CAN-PDP trial to the brains of people with Parkinson’s, but without psychosis, and healthy volunteers without Parkinson’s using magnetic resonance imaging (MRI). Hence this mechanistic MRI control study.

  In order to do this we will include:
  1.20 participants with Parkinson’s disease (without psychosis)
  2.20 healthy controls

  Both groups will undergo the following study-related procedures:
  •Screening visit where will assess eligibility and collect baseline demographic and clinical data
  •Questionnaires to assess for Parkinson’s disease, cognitive impairment and psychotic symptoms
  •MRI scanning session that will last approximately 60 minutes at King’s College London, Denmark Hill

  Neuroimaging data will be acquired using well-established protocols (both task-based and resting fMRI and structural MRI) on the 3T MRI scanner at the NIHR King's Wellcome Clinical Research Facility or Centre for Neuroimaging Sciences, Denmark Hill.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  21/LO/0135

• Date of REC Opinion

  12 Feb 2021

• REC opinion

  Favourable Opinion