Funded Studies
Objective/Rationale:
Some people with Parkinson’s may develop dementia during their disease course. Being able to detect problems with mental function at an early stage, to monitor and to reliably detect treatment benefits relies critically upon the use of scales. As things stand, there are several scales that record cognitive impairments, but researchers do not know which is best, since they have not been tested against each other. This study aims to comprehensively address this shortfall in knowledge.
Project Description:
The Scales Assessment Study will take advantage of a funded drug trial poised to start early 2012 in the United Kingdom. This study, MUSTARDD-PD, will compare a treatment called donepezil against placebo in 500 people with Parkinson’s and mild dementia. There are 22 sites in the UK signed up to participate in MUSTARDD-PD. The Scales Assessment Study will be nested within the protocol, adding four additional scales to those already measuring outcomes in MUSTARDD-PD. Scale performance will be judged against a composite measure, which takes into account how the study participant is doing as compared with their entry into the study. Although long-term, this study promises to provide a comprehensive comparative scale assessment.
Relevance to Diagnosis/Treatment of Parkinson’s Disease:
This study will inform the scientific community of the optimal scale to use in monitoring cognitive performance over time and assessing response to drug interventions. As such, it is likely to have world-wide impact as the findings will have widespread utility and be globally disseminated.
Anticipated Outcome:
Knowing which scale is most able to detect changes in cognitive function with time and able to pick up treatment effects is of huge importance when planning clinical studies and trials. Additionally, researchers will establish the “minimal clinically important change” for the best performing instrument: In other words, the numbers have changed, but does it matter to the patient? They will also compare scale performance against changes in patient (and carer) quality of life to provide a further measure of clinical significance.
*This study has been terminated and is no longer recruiting subjects*