Wearable Assessments in the Clinic and Home in PD (WATCH-PD)

• ClinicalTrials.gov Identifier: NCT03681015
• Recruitment Status: Active, not recruiting
• First Posted: September 21, 2018
• Last Update Posted: March 19, 2021
• Sponsor: University of Rochester
• Collaborators: Biogen; Takeda
• Information provided by (Responsible Party): Ray Dorsey, University of Rochester

Study Description

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.

Condition or disease
Parkinson Disease

Detailed Description:

Subjects will be evaluated via both in-clinic and at-home assessments. The in-clinic assessments are designed to compare the ability of current Parkinson disease clinical trial measures with the ability of mobile and wearable devices to detect disease progression in the early stage of disease. The at-home assessments are designed to determine the feasibility of motor and non-motor assessments of disease progression using a commercially available wearable device/mobile application platform and to determine how this data compares with traditional clinical measures.

Study Design

• Study Type: Observational
• Estimated Enrollment: 135 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects With Early, Untreated Parkinson Disease
• Actual Study Start Date: April 24, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: May 31, 2022

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 12 months ]
   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.
2. 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. [ Time Frame: 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.

Secondary Outcome Measures :

1. 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. [ Time Frame: 12 months ]
   Features extracted from continuous accelerometer and gyroscope signals, recorded during the UPDRS part 3 will be correlated with scores on the UPDRS 1b and 2 subtests to examine how sensor-derived measures relate to patient reported activities of daily living and quality of life.
2. 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. [ Time Frame: 12 months ]
   Features extracted from continuous accelerometer and gyroscope signals, recorded during the UPDRS part 3 will be correlated with scores on the PDQ-8 to examine how sensor-derived measures relate to patient reported quality of life.

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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.

Criteria

Cohort 1 (PD Participants) Inclusion Criteria:

1. Able to give written informed consent, as determined by the investigator.
2. 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.
3. Screening dopamine transporter (DAT) SPECT scan is consistent with dopamine transporter deficit.
4. A diagnosis of Parkinson disease for 2 years or less at screening.
5. Modified Hoehn and Yahr stage <=II at screening.
6. 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).
7. Male or female age 30 years or older at time of PD diagnosis.
8. 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).
9. 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).
10. Fluent in English and able to read.
11. Able to perform all study activities (including walking tasks and timed up and go)
12. Willingness and ability to comply with study requirements.

Cohort 1 (PD Participants) Exclusion Criteria

1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
2. History of PD-related freezing episodes or falls.
3. 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.
4. History of a brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality as determined by the investigator.
5. 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.
6. 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.

7. 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.

8. 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.
9. Montreal Cognitive Assessment (MoCA) score < 24 at screening.
10. 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
11. Known hypersensitivity to DaTscanTM or any of its excipients
12. Body habitus that would impede completion of DaTscanTM (subject weight above 158 kg should be discussed with the Clinical Monitor)
13. Resides in a nursing home or assisted care facility.
14. 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.

Cohort 2 (Control Participants) Inclusion Criteria:

1. Able to give written informed consent, as determined by the investigator.
2. Male or female age 30 years or older at time of PD diagnosis.
3. Fluent in English and able to read.
4. Able to perform all study activities (including walking tasks and timed up and go)
5. Willingness and ability to comply with study requirements.

Cohort 2 (Control Participants) Exclusion Criteria:

1. A diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
2. History of PD-related freezing episodes or falls.
3. 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.
4. History of a brain magnetic resonance imaging (MRI) scan indicative of clinically significant abnormality as determined by the investigator.
5. 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.
6. 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.
7. 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.
8. Montreal Cognitive Assessment (MoCA) score < 24 at screening.
9. Resides in a nursing home or assisted care facility.
10. 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.
11. Is pregnant (or is planning to become pregnant during the study period) or lactating.

Contacts and Locations

Locations

United States, Arizona

Banner Sun Research Institute

Sun City, Arizona, United States, 85351

United States, California

University of California San Francisco

San Francisco, California, United States, 94115

United States, Colorado

University of Colorado Denver

Aurora, Colorado, United States, 80045

United States, Florida

University of South Florida

Tampa, Florida, United States, 33613

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

United States, Nevada

Cleveland Clinic Nevada

Las Vegas, Nevada, United States, 89106

United States, New York

Northwell Health

Great Neck, New York, United States, 11021

NYU Langone Health

New York, New York, United States, 10017

University of Rochester

Rochester, New York, United States, 14620

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45219

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Sentara Clinical Research

Virginia Beach, Virginia, United States, 23456

Sponsors and Collaborators

University of Rochester

Biogen

Takeda

Investigators

• Principal Investigator: Earl R Dorsey, MD MBA; University of Rochester

More Information

• Responsible Party: Ray Dorsey, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03681015
• Other Study ID Numbers: WPD-01
• First Posted: September 21, 2018
• Last Update Posted: March 19, 2021
• Last Verified: December 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases