Being a phase 2 study means it has robust controls in place so that the results will come with a good degree of confidence, rather than being due to chance or the placebo effect .
As well as having funding from Cure Parkinson’s the study is being supported by the Van Andel Institute, JP Moulton Foundation and PRO.MED.CS.
The study involves 30 people with a diagnosis of Parkinson’s made not more than three years ago. Participants are randomly assigned to take UDCA – at double the dose that is used for liver disease – or an identical-looking placebo. Neither the participants nor the researchers know who is taking which.
UP-Study is being run at two centres: Royal Hallamshire Hospital in Sheffield, and University College London Hospitals. Participants will attend their nearest centre several times for various assessments.
Movement symptoms, such as tremor, speech, rigidity and walking will be assessed at the start, during and after 48 weeks of treatment. This will be done by standard tests and observation in hospital appointments, and also through the use of wearable technology at home.
In hospital, movement symptoms will be assessed in the ‘off state’; when participants have temporarily paused their normal Parkinson’s medication, and their effects have worn off. This is to get an indication of how advanced the disease is, and its progression, when symptoms are not being controlled by drugs.
Brain chemistry will be measured by a method called MRI spectroscopy. This is a scan that will quantify how the mitochondria in the brain are working, by measuring the levels of molecules in the cells. It will detect if the levels of cellular energy – in the form of ATP – are maintained, rise or fall during the study period.