If you get to the end of this article and would like to take the next step, the contact information you need is in the PADOVA Participant Information Sheet.
This study is recruiting about 575 people, which sounds like – and is – a lot. It is a multi-country study arranged in many locations. It requires a lot of skilled resource in a study centre. Herein lies the rub. Many people in total nevertheless means few places available “in a study centre near you”.
You will not be pressured to volunteer for a place on the study run by the Lind Centre at Derriford Hospital. But after a time you will no longer have the opportunity. As one might say “these local places, when they’re gone, they’re gone”.
This is an edited text-only version of the presentation that Roche Prothena, the sponsors of the study, have prepared. It is intended to be given by the Principal Investigator for a Study Centre to a PwP (Person With Parkinson’s) and their care partner.
This presentation may be the first conversation with a PwP who has been invited in to a Study Centre, or has contacted the Centre to express interest. The aim of the presentation is to help the PwP participant to be clear about whether this study is “right for them”, and to gain their signature to the Informed Consent Form (ICF, see below).
Participation is stressed to be entirely voluntary and that they can leave at anytime.
The local Study Centre is the Lind Research Centre at Derriford Hospital.
What is PADOVA?
The PADOVA Study intends to find out whether a new investigational medication called Prasinezumab can slow disease progression for people in the early stage of Parkinson’s. To qualify for assessment, the participant must:
- Be aged between 50 and 85
- Have been diagnosed with Parkinson’s disease for between six months and three years
- Have been receiving either MAO-B inhibitors (e.g. rasagiline) or levodopa/carbidopa (e.g. Madopar, Sinemet) for at least six months.
Current treatments for Parkinson’s focus on treating the symptoms rather than the cause. Prasinezumab is designed to work differently, it targets a toxic protein that is thought to be responsible for the nerve cell damage associated with the condition. The study is investigating whether Prasinezumab is a safe and effective way to slow down this nerve cell damage.
What is involved?
Every clinical research study follows a plan known as a protocol. This study protocol has three stages:
- A screening period of 4 to 12 weeks
- A treatment period between 12 and approximately 18 months
- A follow up period of approximately 10 weeks
Before the screening period we will carry out some tests and give you a smart watch and smartphone so that you can carry out some further tests from home. (Spoiler alert: it cannot be used as a phone!)
For the treatment period you will be randomly assigned to receive either Prasinezumab or a placebo, and you will take your regular Parkinson’s medication. The placebo is a dummy medication that is given in the same way as Prasinezumab but it contains no active medicine.
The protocol is “double blind” which means that neither you nor the study investigator will know which study medication you are on.
Both Prasinezumab and the placebo will be administered by intravenous infusion (often called an IV ‘drip’). You will visit the Lind Centre every four weeks to receive an infusion. The first three doses will be given over 2 hours. If these are tolerated well the infusion time may be reduced to 1 hour for the remaining doses.
So that can we also closely monitor your general health and see how you are responding to your assigned study medication, during your visits we will conduct several health assessments. These will vary from visit to visit, and could include neurological examinations, blood tests, urine tests, physical examination, brain scans and ECGs. Each of these visits will last between four and six hours. You will be expected to visit the study centre approximately every four weeks at least 22 times in total.
During the study we will ask you to use the smartphone app to help us manage your condition. Full training will be provided. We will also carry out certain assessments over the telephone.
What should I be thinking about?
The potential benefits:
- Your health may improve
- You will be contributing to our knowledge of Parkinson’s disease
- You may help us treat other people with the condition in the future
- Frequent health monitoring.
The potential risks:
- Your health may not improve and could get worse
- Some of the health assessments may be uncomfortable
- Prasinezumab could cause side effects or affect your health in ways we do not yet know about.
If you are considering joining the study feel free to share and discuss this information with your family, friends and doctor. Please read the Informed Consent Form carefully.
And remember, participation is voluntary.
You can read and download the Participant Information Sheet, which includes the Informed Consent Form. Another 10 out of ten for “participant” instead of “patient” (see also Neuroderm)!