Utilization of Target Ranges to Treat Patients With Parkinson’s Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PD)- A Randomized Controlled Trial

Sponsor:

Brief Summary:

The main objective of this study is to evaluate whether people whose PD symptoms are
uncontrolled who are managed with the aid of objective measurement and use of target ranges
have improved PD symptoms and outcomes as compared to individuals treated using only standard
of care (medical history, neurological examination).

Criteria

Inclusion Criteria:

– Able and willing to sign a written informed consent for study participation

– Presumed to have Levodopa responsive idiopathic Parkinson’s Disease

– Age inclusive at the time of consent per PKG Indications for Use (46-83 years old)

– Has not been previously managed with the PKG

Exclusion Criteria:

– Contraindication to increasing levodopa (e.g. orthostatic hypotension,
hallucinations/psychosis or any other medical condition in the last year that would
preclude increasing levodopa or other appropriate Parkinson’s Disease medications)

– MoCA score <23 at screening visit - Diagnosis of Essential Tremor - Wheelchair bound or bedridden - Currently utilizing or planning in the next 6 months advanced PD therapies (DBS, infusion, etc.) - In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints (e.g., subject unable to complete PKG watch wear instructions per Patient Instruction Manual)

Locations

Parkinson’s Disease and Movement Disorders Center of Silicon Valley, Menlo Park, California, United States, 94025