Study Goal:

This study is looking at a mew medication that could improve the lives of people with Parkinson's Disease. Participation in this clinical study is very important - it may advance the knowledge of Parkinson's disease. While there may be no benefit to you, this research may benefit others in the future. 

What's Involved:

The study has two parts, Part A: Genetic Screening and Part B: Clinical Trial of the Drug. 

Part A Genetic Screening and Counselling: 

A genetic screening to determine if you qualify for the study looking at mutations in GBA1 and LRRK2 genes.  (GBA1 gene mutation required).

Two visits to identify individuals with a PD risk- associated variant in the GBA1 gene. The results of the genetic testing may be communicated by telephone if no mutation is found but must be communicated during an in person visit if a GBA1 (glucocerebrosidase 1) or LRRK2 (Leucine-rich repeat kinase 2) variant is detected. Part A visit number 2 might be the same as Part B visit number 1 if the participant is eligible and wishes to take part in Part B.  

Part B Double Blind Treatment Period: 

If you qualify, you will be invited into the second part of the study, which will include different tests and assessments, and potentially taking the new medication

Those who are eligible and agree to take part will be randomly allocated into one of three groups. This means there is an equal chance of being put into any one of these groups. The three groups include 1) placebo group whereby participants will take a fake pill instead of the active drug, 2) low dose of the active drug, 3) higher dose of the active drug.  

• The screening period will take up to 6 weeks 

• The double-blind treatment period, whereby the participants will take the drug or placebo will be 78 weeks in duration 

• There is then a safety follow up period of 30 days 

Participation is voluntary. It is entirely up to you whether you take part or not. If you agree to take part, you are still free to withdraw from the study at any time, for any reason or event without providing a reason, without penalty or loss of benefits to which you are otherwise entitled. 

Who Can Take Part?

There is a long list of eligibility criteria that would need to be discussed with a doctor, but you may be eligible to participate if: 

• You were diagnosed with Parkinson's disease in the last 7 years 

• You are between the ages of 35 and 80 years old  

Who to contact?

• Glasgow Memory Clinic: Dr Donald Grosset, donald.grosset@gmclinic.co.uk

• The Newcastle upon Tyne Hospitlas, Dr David Ledingham, david.ledingham1@nhs.net

• NHS Tayside-Ninewells Hospital and Medical School, Dr Esther Sammler, e.m.sammler@dundee.ac.uk

• University Hospitals Plymouth, Dr Stephen Mullin, stephen.mullin@plymouth.ac.uk 

• Kings College London, Professor Ray Kallol Chaudhuri, ray.chaudhuri@kcl.sc.uk