Wearable Assessments in the Clinic and Home in PD
WATCH-PD
A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects With Early, Untreated Parkinson Disease
1 other identifier
observational
132
1 country
17
Brief Summary
The purpose of this study is to evaluate disease progression in persons with early Parkinson disease, as assessed by digital and electronic sensor data collection to be correlated with typical clinical assessments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedJune 1, 2026
September 1, 2022
2.8 years
September 10, 2018
May 27, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change and variability in inertial sensor-derived measures of motor function from baseline to 12 months during performance of the MDS-UPDRS part 3 motor exam.
Features will be extracted from continuous accelerometer and gyroscope signals, obtained via a set of body-worn inertial sensors, during performance of the MDS-UPDRS part 3, and the change and variability of these features will be assessed.
12 months
Correlations between inertial sensor-derived measures of motor function and clinician ratings during performance of the MDS-UPDRS part 3 and total exam at baseline, 1, 3, 6, 9, and 12 months.
Features extracted from continuous accelerometer and gyroscope signals recorded during each relevant component of the UPDRS part 3 will be correlated with corresponding clinician ratings to quantify the relationship between these measures.
12 months
Secondary Outcomes (2)
Correlations between sensor-derived measures of motor function (accelerometer, gyroscope) and patient-reported outcomes measured by MDS-UPDRS parts 1b and 2 at baseline, 1, 3, 6, 9, and 12 months.
12 months
Correlations between sensor-derived measures of motor function (accelerometer, gyroscope) and patient-reported outcomes measured by PDQ-8 at baseline, 1, 3, 6, 9, and 12 months.
12 months
Study Arms (2)
Cohort 1 - Parkinson's Disease Participants
Volunteers will be women and men with early, untreated Parkinson disease.
Cohort 2 - Control Participants
Participants will be women and men without PD.
Eligibility Criteria
Cohort 1 (PD Participants): Male and female subjects with early, untreated Parkinson's disease, aged 30 years or older at time of disease diagnosis Cohort 2 (Control Participants): Male and female subjects without Parkinson's disease, aged 30 years or older.
You may qualify if:
- Able to give written informed consent, as determined by the investigator.
- Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia as one of two symptoms); OR either asymmetric resting tremor or asymmetric bradykinesia.
- Screening dopamine transporter (DAT) SPECT scan is consistent with dopamine transporter deficit.
- A diagnosis of Parkinson disease for 2 years or less at screening.
- Modified Hoehn and Yahr stage \<=II at screening.
- Not expected to require PD medication for at least 6 months from baseline (includes dopaminergics, MAO-B inhibitors, and anti-cholinergics used to treat PD-related symptoms).
- Male or female age 30 years or older at time of PD diagnosis.
- Female subjects of childbearing potential must agree to be using highly effective contraception within 30 days prior to DaTscan (e.g., oral contraceptives, a barrier method of birth control (e.g., condoms with contraceptive foam, diaphragm with contraceptive jelly), intrauterine device, partner with vasectomy or sexual abstinence).
- Male subjects who are fertile and have a partner of childbearing potential must agree to use reliable contraception for 14 days following the administration of DaTscanTM (e.g., condoms with contraceptive foam or sexual abstinence).
- Fluent in English and able to read.
- Able to perform all study activities (including walking tasks and timed up and go)
- Willingness and ability to comply with study requirements.
You may not qualify if:
- A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
- History of PD-related freezing episodes or falls.
- A diagnosis of a significant CNS disease other than PD; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child that would interfere with ability to perform study assessments.
- History of a brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality as determined by the investigator.
- Concomitant disease, condition, medication, or laboratory abnormality that, in the opinion of the investigator, could interfere with study conduct or analysis, or pose an unacceptable risk to the participant. This could include neurologic, orthopedic or cardiovascular diseases.
- Has taken levodopa, dopamine agonists, MAO B inhibitors, amantadine, anticholinergics or other medication for the treatment of PD or tremor within 60 days prior to baseline, or for more than a total of 60 days.
- Is taking medication for the treatment of tremor at the baseline visit. If taking medication for tremor at the screening visit, this medication must be stopped at least 14 days prior to baseline. If taking a tremor medication for another indication (e.g.
- hypertension, neuropathy), the medication can be continued during the study.
- For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (modafinil, bupropion, methylphenidate, neuroleptics, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to withhold the medication for at least 14 days prior to screening DaTscan imaging.
- Montreal Cognitive Assessment (MoCA) score \< 24 at screening.
- Is pregnant (or is planning to become pregnant during the study period) or lactating (includes a negative urine (or serum if required by site) pregnancy test on day of screening scan prior to injection of DaTscanTM
- Known hypersensitivity to DaTscanTM or any of its excipients
- Body habitus that would impede completion of DaTscanTM (subject weight above 158 kg should be discussed with the Clinical Monitor)
- Resides in a nursing home or assisted care facility.
- Use of investigational drugs (other than imaging agents) or devices (other than mobile/wearable devices used in this study) within 60 days or 5 half-lives of study agent prior to baseline and during the study period.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Biogencollaborator
- Takedacollaborator
Study Sites (17)
Banner Sun Research Institute
Sun City, Arizona, 85351, United States
University of California San Francisco
San Francisco, California, 94115, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
University of South Florida
Tampa, Florida, 33613, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Cleveland Clinic Nevada
Las Vegas, Nevada, 89106, United States
Northwell Health
Great Neck, New York, 11021, United States
NYU Langone Health
New York, New York, 10017, United States
University of Rochester
Rochester, New York, 14620, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
Sentara Clinical Research
Virginia Beach, Virginia, 23456, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Earl R Dorsey, MD MBA
University of Rochester
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 10, 2018
First Posted
September 21, 2018
Study Start
April 24, 2019
Primary Completion
February 21, 2022
Study Completion
March 30, 2022
Last Updated
June 1, 2026
Record last verified: 2022-09