Trial results for a feasibility study in Parkinson's Disease were posted on 2026-05-08, showing a mean change of -0.6 (Standard Deviation 1.54) in the Parkinson's Disease Related Pattern (PDRP) Z-score during a one-week medication washout.
Background
Parkinson's Disease is a progressive neurodegenerative disorder affecting movement, balance, and other functions. Accurate and objective measures are crucial for evaluating the efficacy of potential disease-modifying therapies in clinical trials. Current clinical trials often rely on a combination of subjective and objective assessments, and the logistics of medication washout periods can be challenging for both patients and researchers. This study aimed to explore the feasibility of incorporating objective measures, such as advanced imaging and wearable biosensors, and conducting medication washout in an outpatient setting, which could streamline future research and potentially reduce patient burden.
Trial design
This completed study enrolled 20 participants with Parkinson Disease. The trial's objective was to assess the feasibility of integrating objective measures, including FDG-PET imaging and wearable biosensors, into a week-long medication washout protocol for early-stage Parkinson's disease patients. It also investigated whether this washout period could be effectively managed in an ambulatory (outpatient) setting.
Key results
The trial evaluated several objective measures during the one-week medication washout period in early-stage Parkinson's Disease patients:
- Changes in the Parkinson's Disease Related Pattern (PDRP) Z-Score From ON Medications to One-week OFF Medications: The mean change was -0.6 (Standard Deviation 1.54) Z score.
- Changes in the Parkinson's Disease Cognitive Pattern (PDCP) Z-Score From ON Medications to One-week OFF Medications: The mean change was 0.12 (Standard Deviation 0.92) Z-score.
- Daily Kinesia ONE Finger Tapping Speed Scores Over a One-week Medication Washout: Mean scores were 0.99 (Standard Deviation 0.66), 1.04 (Standard Deviation 0.54), 1.18 (Standard Deviation 0.52), 1.24 (Standard Deviation 0.58), 1.38 (Standard Deviation 0.59), 1.36 (Standard Deviation 0.55), 1.47 (Standard Deviation 0.49), and 1.33 (Standard Deviation 0.56) units on a scale.
- Daily Kinesia ONE Rest Tremor Scores Over a One-week Medication Washout: Mean scores were 0.32 (Standard Deviation 0.43) and 0.35 (Standard Deviation 0.46) units on a scale.
What this means
The results of this feasibility study suggest that objective measures, such as PDRP and PDCP Z-scores, along with data from wearable biosensors like Kinesia ONE for finger tapping speed and rest tremor, can detect changes during a medication washout period in early-stage Parkinson's Disease. The observed mean change of -0.6 in PDRP Z-score indicates a measurable effect. Furthermore, the successful completion of the study, which included an outpatient washout protocol, implies that such methodologies are feasible for integration into future disease-modifying clinical trials. This could potentially lead to more efficient and less burdensome trial designs for patients, facilitating the development of new treatments for Parkinson's Disease by providing more robust and objective outcome measures.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06192823, titled "Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease", were posted on 2026-05-08 on clinicaltrials.gov.