Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG

Study Overview
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Brief Summary
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The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).

Detailed Description
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This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional PD treatment through 3 years follow-up of PwP specifically treated to a target range when using the PKG data in the clinical management of PD in routine clinical care compared to those managed with SOC alone. All subjects will be treated by Movement Disorder Specialists and General Neurologists with expertise in PD. Both groups will be recommended to undergo treatment changes until they reach a controlled state that is determined by either the clinician using SOC (PKG- Group) or using recommended target ranges for PKG scores and SOC assessments (PKG+ Group). Investigators will utilize standard available treatments to manage these PwP in both groups.

Official Title
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Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the Personal KinetiGraph® (PKG®) Compared to Standard of Care Assessment (TARGET-PwP)- A Randomized Controlled Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Personal KinetiGraph® (PKG®) System
* Device: Personal KinetiGraph® (PKG®) Watch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits Presumed to have levodopa responsive PD Taking levodopa for at least 30 days prior to screening visit Planning to continue using levodopa for PD throughout study participation Able to increase levodopa by a minimum of 100mg/day Age inclusive at the time of consent of 55-80 years Has not received a PKG in the last 12 months Exclusion Criteria: Evidence of atypical or secondary parkinsonism Presence of any non-parkinsonian tremors Contraindication to increasing levodopa Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months MoCA score <23 at screening visit Bedridden, wheelchair confined, or requires the regular use of an assistive gait device Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker) 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible subjects will be randomized using the Electronic Data Capture (EDC) system in a 1:1 ratio to the PKG- Group (standard of care clinical assessments without use of PKG data) or the PKG+ Group (standard of care clinical assessments plus use of PKG data).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PKG+ Group<br>For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is in the target range or out of the target range based on scores provided by the PKG. | Device: Personal KinetiGraph® (PKG®) System<br>* The Personal KinetiGraph (PKG®) System consists of the following: A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period Proprietary algorithms to translate raw movement data collected by the PKG® Watch Data-driven report known as the PKG® The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors.<br>|
| Placebo Comparator: PKG- Group<br>For subjects in the PKG- Group, participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. | Device: Personal KinetiGraph® (PKG®) Watch<br>* The Personal KinetiGraph (PKG®) System consists of the following: A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period Proprietary algorithms to translate raw movement data collected by the PKG® Watch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Outcomes using Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The change in MDS-UPDRS Total score at 4 months from baseline defined as sections I, II, III (per core lab measurement) and IV in PwP. The endpoint will be compared between subjects out of target at baseline for those who are treated with SOC and PKG data (PKG+ Group) versus those who are treated per SOC alone (PKG- Group). | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate for total MDS-UPDRS | Percent responders for total MDS-UPDRS based on a minimal clinically important change of >4 points (Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The Clinically Important Difference on the Unified Parkinson's Disease Rating Scale. Arch Neurol 2010: 67(1):64-70.). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | 4 months | 
| Responder rate for PKG | Percent responders by PKG (defined as BKS change of >2 point improvement) | 4 months | 
| Change in MDS-UPDRS motor endpoints | Change in MDS-UPDRS Part III (per core lab measurement). The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Part III is the motor examination and contains 33 questions/evaluations. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | 4 months, 1 year, 2 years, 3 years | 
| Change in MDS-UPDRS total | Change in MDS-UPDRS Total score from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | 1 year, 2 years, 3 years | 
| Change in MDS-UPDRS sub parts | Change in the non-motor (parts I and II) score and change in Part IV for the MDS-UPDRS from baseline. The Movement Disorder Specialist - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates motor and non-motor symptoms in persons with Parkinson's and consists of 4 parts with various questions and evaluations. Parts I and II (non-motor) each contain 13 questions/evaluations, Part III (motor) contains 33 and Part IV (motor) contains 6. Each question/evaluation score ranges from 0 (normal) to 4 (severe). Higher scores indicate a greater impact of Parkinson's disease symptoms (i.e., worse symptoms). | 4 months, 1 year, 2 years, 3 years | 
| Change in PKG Bradykinesia Score (BKS) | Change in the PKG reported BKS from baseline. A higher score represents more severe bradykinesia. | 4 months, 1 year, 2 years, 3 years | 
| Change in PKG Dyskinesia score (DKS) | Change in the PKG reported DKS from baseline. A higher score represents more severe dyskinesia. | 4 months, 1 year, 2 years, 3 years | 
| Change in Percent Time in Tremor (PTT) | Change in the PKG reported PTT from baseline, max 100%. A PTT of >1% indicates that tremor is present. | 4 months, 1 year, 2 years, 3 years | 
| Change in Fluctuation Dyskinesia score (FDS) | Change in the PKG reported FDS from baseline. The higher the score, the more severe the fluctuation, and a FDS of 7.5-13 indicates controlled fluctuations. | 4 months, 1 year, 2 years, 3 years | 
| Change in Percent Time Immobile (PTI) | Change in the PKG reported PTI from baseline, max 100%. A PTI of >5% is considered high. | 4 months, 1 year, 2 years, 3 years | 
| Change in Parkinson's Disease Questionnaire-39 questions (PDQ-39) | Change in the patient reported quality of life questionnaire PDQ-39 from baseline. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life issues across 8 dimensions. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life. | 4 months, 1 year, 2 years, 3 years | 
| Number of Interim Visits | Number of interim visits conducted from baseline to 4 months in each arm | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personal KinetiGraph® (PKG®) System, Objective Measurement