The UP Study, or UDCA for Parkinson’s Study, was a phase 2 clinical trial which aimed to assess the safety and tolerability of ursodeoxycholic acid (UDCA) in people with Parkinson’s.
About the study
Led by Professor Oliver Bandmann at the University of Sheffield, this study recruited 30 people with Parkinson’s, with 2/3 of participants taking UDCA and the remaining third taking a placebo (dummy drug) daily for 48 weeks. Various measurements were taken from participants before, during, and after the trial for analysis, including standard ratings of motor symptoms (MDS UPDRS Part III).
Alongside the main trial, Cure Parkinson’s funded a sub-study looking at brain imaging and an evaluation of participant’s movement using a sensor-based approach. The goal of these were to provide evidence towards additional exploratory objectives: if UDCA affected brain chemistry and whether it had any effect on the progression of motor symptoms.
Trial overview
- Researcher: Professor Oliver Bandmann
- Institution: University of Sheffield
- Project Type: Clinical Trial, Phase 2
- Status: Completed
- Dates: Dec 2018 – May 2022
- iLCT-evaluated (2015)
- Therapy Target: Mitochondrial dysfunction
More about the study
What is UDCA?
UDCA is a naturally occurring bile acid which was approved for use in the 1980s to treat gallstones and a rare form of liver disease called primary biliary cirrhosis. Additional research since has shown that UDCA may also have a positive effect on mitochondria – the part of the cell that produces energy. Issues with mitochondria are thought to be a driver of nerve cell (neuron) loss in Parkinson’s; therefore, if UDCA can help restore energy production, it may be able to slow progression.
Read more about mitochondrial dysfunction and Parkinson’s In 2013, Prof Bandmann and colleagues at Sheffield performed a large-scale screening study to assess 2,000 compounds for their ability to improve energy production. Using skin cells from people with Parkinson’s, the team found UDCA could rescue mitochondrial function and normalise energy levels in cells (https://pubmed.ncbi.nlm.nih.gov/24000005/). This, alongside other similar studies, led to UDCA being prioritised for clinical trial by the iLCT committee in 2015.
Results
The results for the UP Study were published in June 2023, where the researchers reported the trial had met its primary outcome, indicating UDCA was safe and tolerable when taken by participants.
In the two sub-studies, researchers found evidence of improved energy production and possible improvements in participant’s gait (the way someone walks) for those taking UDCA. Whilst these results indicate UDCA could have an effect on slowing Parkinson’s progression, it will be necessary for this to be further tested in a larger group of people with Parkinson’s.
Read more about these results: https://cureparkinsons.org.uk/2023/06/phase-2-udca-in-parkinsons-trial-results-published/
Video presentation – Professor Oliver Bandmann presents on the UP study results at one of our Research Update Meetings
Further information
Publications
A Double-Blind, Randomized, Placebo-Controlled Trial of Ursodeoxycholic Acid (UDCA) in Parkinson’s Disease – https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29450
Phase 2 UDCA in Parkinson’s trial results published
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