Parkinson's Disease
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Verily Life Sciences LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements, including adherence to Study Watch wearing, daily charging/syncing, submission of periodic patient-reported outcome measures, tagging medication ingestion on the Study Watch each day, and performing simple, standardized motor tasks. 2.The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3.The participant has been diagnosed with Parkinson's disease for at least 5 years. 4.The participant is male or female and aged 20 years or older at the time of informed consent. 5.The participant is treated with oral levodopa with/without other medications. 6.The participant has clear-cut and robust response to levodopa, historically and presently, based on history and/or formal clinical off- and on-medication exam. 7.The participant is experiencing motor fluctuations, with at least one troubling motor "off" period each day (with/without dyskinesia). 8.The participant is scheduled for an at least 5-day hospitalization as part of routine clinical care for in-depth evaluation of motor function, with or without other therapeutic intervention.
Exclusion criteria
Exclusion criteria: 1.The participant has nickel or metal jewelry allergy. 2.The participant has cognitive impairment that, in the opinion of the investigator, would interfere with the ability to report on symptoms and function. 3.The participant has another medical condition that would interfere with interpretation of parkinsonian motor symptoms (e.g., significant musculoskeletal disorder). 4.The participant has any risk that, in the opinion of the investigator, would harm his/her health with performing structured tasks at home. 5.The participant is judged by the investigator as being ineligible for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other Device Digital Measurement of Motor Function Timeframe: Up to 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| other Device Digital Measurements identified as Correlate with MDS-UPDRS Scores Timeframe: Up to 2 months other Comparison of Device Digital Measurement Before and After Medication Dosing Timeframe: Up to 2 months other Proportion of Structured Tasks Completed Timeframe: Up to 2 months other Mean Daily Wear Time of Digital Device Timeframe: Up to 2 months | — |
Countries
Japan
Outcome results
None listed