WATCH-PD: Wearable Assessments in the Clinic and Home in PD

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT03681015
• Collaborator: Biogen (Industry), Takeda (Industry)
• Enrollment: 132
• Locations: 17
• Actual Duration (Months): 35.2
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.2

Study Details

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	Intervention/Treatment	Phase
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
• Actual Enrollment: 132 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: Apr 24, 2019
• Actual Primary Completion Date: Feb 21, 2022
• Actual Study Completion Date: Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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. [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. [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. [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. [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

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

1. 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.

2. Montreal Cognitive Assessment (MoCA) score < 24 at screening.

3. 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

4. Known hypersensitivity to DaTscanTM or any of its excipients

5. Body habitus that would impede completion of DaTscanTM (subject weight above 158 kg should be discussed with the Clinical Monitor)

6. Resides in a nursing home or assisted care facility.

7. 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

	Site	City	State	Country	Postal Code
1	Banner Sun Research Institute	Sun City	Arizona	United States	85351
2	University of California San Francisco	San Francisco	California	United States	94115
3	University of Colorado Denver	Aurora	Colorado	United States	80045
4	University of South Florida	Tampa	Florida	United States	33613
5	Northwestern University	Chicago	Illinois	United States	60611
6	University of Michigan	Ann Arbor	Michigan	United States	48109
7	Cleveland Clinic Nevada	Las Vegas	Nevada	United States	89106
8	Northwell Health	Great Neck	New York	United States	11021
9	NYU Langone Health	New York	New York	United States	10017
10	University of Rochester	Rochester	New York	United States	14620
11	University of Cincinnati	Cincinnati	Ohio	United States	45219
12	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
13	Oregon Health and Science University	Portland	Oregon	United States	97239
14	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19107
15	Baylor College of Medicine	Houston	Texas	United States	77030
16	Virginia Commonwealth University	Richmond	Virginia	United States	23284
17	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ray Dorsey, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03681015
• Other Study ID Numbers: WPD-01
• First Posted: Sep 21, 2018
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease

Study Results

No Results Posted as of May 17, 2022