Objective: To establish whether using the Parkinson’s KinetiGraph™ which provides objective measures in activities of daily living, helps identify unknown poorly controlled patients with Parkinson’s (PwP), and whether changing their therapy improves patient outcomes. This abstract presents interim study results.

Background: In any Parkinson’s disease patient population, there will be well controlled (WC) and poorly controlled (PC) patients. PC includes PwP in whom symptoms were known but the severity was not appreciated or poor control was not recognized. Objective measurement may help identify PwP who are PC, inform therapeutic decision-making, and support improved patient outcomes.

Methods: General Neurologists (GN) recruited PwP from their practice whom they considered to be WC, had no contraindication to increasing levodopa and were taking 4 or more doses of levodopa/day. All patients wore a PKG and were assessed by a Movement Disorder Specialist (MDS). The MDS was randomly assigned to first report the PKG or see the patient: in each case, they noted whether they would treat and how. They then advised the patient using both the PKG and consultation. Targets from PKG values were developed as guidelines to aid therapeutic decisions and subjects underwent up to three follow-up visits with a PKG to optimize care. The primary endpoint was the proportion of subjects who were PC. Secondary endpoints were improvements in patient outcomes.

Results: At the time of interim analysis, 24 patients were enrolled in the study. Of these, 5 subjects were excluded (80% were untreated postural hypotension). Of the 19 eligible subjects, 3 subjects were considered WC, whereas 16 subjects (84%) were considered PC and consequently treatment was change. The MDS would have not recognized 6 of the 19 (32%) eligible subjects as PC without the PKG, and in 10 subjects (53%) the MDS recognized the same symptoms as the PKG. There were no examples in which the PKG failed to recognize treatable symptoms. Fifteen (15) of the 16 subjects (94%) were treated for bradykinesia or fluctuations (wearing-off). Clinically significant changes in patient outcomes were noted in the UPDRS, PKG scores, and PDQ8.

Conclusions: Interim results suggest use of the PKG helps identify unknown, poorly controlled patients in clinical practice and their subsequent treatment may significantly improve patient outcomes.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/objective-measurement-in-clinical-care-of-patients-with-parkinsons-disease/