If you are interested in participating in the EJS ACT-PD trial, follow the link to complete the Registration of Interest. (Please note the link will be made available at a later date)
About EJS ACT-PD Trial
The Edmond J Safra, Accelerating Clinical Trials in Parkinson’s Disease (EJS ACT-PD) study is a clinical trial. EJS ACT-PD aims to find one or more treatments for Parkinson’s disease (PD) which can slow down or stop PD symptoms from getting worse.
This trial uses a multi-arm multi-stage design or MAMS design, where multiple treatments are tested at the same time, in separate treatment groups, called "arms". Each treatment is compared against a placebo (a dummy treatment with no active ingredients) to assess how well it is actually working. To find out more about this type of design and how it helps to speed up clinical trial processes, you can visit the "What is a MAMS Trial" page.
During the trial, we will complete an early review, known as 'interim analyses', for each treatment to check whether it is safe and seems to be working. If a treatment appears to be working, then recruitment and follow up will continue until the final review, which tests if it is effective. Treatments that do not appear to be working will be stopped early and can be replaced with new candidate treatments.
We selected the treatments for this trial based on careful consideration of existing evidence regarding their safety and effectiveness.
Participants will take part in the study for up for up to 36 months. Study appointments will take place with a member of the trial team either in-person at a participant's local trial site, or remotely from home. These will take place every 6 months with 2 extra appointments and some additional telephone calls in the first year. The study appointments include questionnaires and video calls to assess Parkinson’s symptoms at different timepoints, and discuss any side effects.
Participants going through the recruitment process will be given the Participant Information Sheet (PIS) by their trial site where they are taking part. You can find the PIS on the Participant Information Sheet page.
Partners of Participants
We will also invite partners or spouses of participants to participate in the trial and ask them to complete questionnaires remotely from home. The Partner sub-study will allow us to evaluate the impact that providing care for a person with Parkinson’s has on the partner’s or spouse’s quality of life and if this changes during the course of the trial.
We recommend potential participants and their partners carefully read the Partner Information Sheet by visiting the Participant Information Sheet Page. You will have the opportunity to discuss the Partner study in more detail and ask any questions you may have when you are contacted by the trial team at your preferred site.
Research Bloods
We will also collect blood samples from participants. These research blood samples will be part of what we call a research ‘biobank’, and are a very valuable resource for researchers to understand more about Parkinson's disease and how we may be able to treat it.
We, or other researchers and organisations, will use the research blood samples to conduct studies about how the body responds to treatments.
Example of the the studies may include analyses:
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to evaluate for predictors of clinical response to study drugs
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to determine early surrogates of efficacy
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to identify predictors of or associations with progression
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to provide evidence of study drug activity
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to increase knowledge and understanding of disease biology and drug safety.
Additional Studies within EJS ACT-PD
The EJS ACT-PD trial is looking at testing new treatments for Parkinson's disease, to slow or stop Parkinson's disease progression. However, the trial team will also be looking at other measurements in what we call sub-studies. Participants will have the option to take part in these sub-studies.
You can find out more about the sub-studies in EJS ACT-PD by clicking on the tabs below.
You can also read the sub-study Participant Information Sheets by visiting the Participant Information Sheet page.
*Available to all participants*
The Digital Measures Study will investigate change in mobility in people taking part in the main EJS ACT-PD study. Our ability to walk (mobility) is an important indicator of our health and well-being, and loss of mobility is an important concern to people with Parkinson’s. Mobility change can happen as Parkinson’s progresses. Measures of mobility may help us measure Parkinson’s progression.
The Axivity Passive Digital Measure
The Passive Digital Measures sub-study will be available to all participants. Participants will be provided with the ‘axivity’ device which is a small sensor attached by adhesive to the lower back. Once attached, the sensor requires no further interaction and continuously captures data related to movement for 7 days.
*Available to participants at selected sites*
Some of the sites delivering the main EJS ACT-PD study will also invite participants to take part in the Biosamples study. This will include participants providing additional blood samples and Cerebral Spinal Fluid (CSF) samples at some trial appointments.
The samples will be used for tests to tell us more about the treatments being tested in EJS ACT-PD, including whether they are able to reach your brain. The blood can also be tested for different ‘biomarkers’ (a biological molecule found in the blood) which can tell us about Parkinson's disease and how the treatments are working. The results of the blood tests can be used to decide if these might be a better way of checking that treatments being tested are working well enough to continue to the next stage of the study. They may also help to understand whether the treatments are effective in slowing down the progression of Parkinson's disease.
*Available to all participants*
We will collaborate with PD Frontline. PD Frontline is a research study that tests samples from people with Parkinson's disease to help identify genes linked to Parkinson’s.
We will complete genetic testing to:
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Check if any of the treatments tested in EJS ACT-PD work better in people with different genetic risks for Parkinson's disease.
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Identify any other genetic factors which may influence response to treatments tested.
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Look at differences in genetic makeup (or DNA) may make someone more or less likely to develop Parkinson's disease, or impact how Parkinson's disease affects the body.
You can find out more about PD Frontline and read their Participant Information sheet by visiting the PD Frontline Website.
EJS ACT-PD
MRC Clinical Trials Unit at UCL
90 High Holborn
London
WC1V 6LJ
mrcctu.ejsactpd@ucl.ac.uk