Wearable Assessments in the Clinic and Home in PD



Status:Not yet recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:4/6/2019
Start Date:April 15, 2019
End Date:August 15, 2021
Contact:Elisabeth A de Blieck, MPA
Email:lisa.deblieck@chet.rochester.edu
Phone:(585) 273-4243

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A Multicenter, Prospective, Longitudinal, Digital Assessment Study of Disease Progression in Subjects With Early, Untreated Parkinson Disease

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.

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.

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 I or 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)

10. Willingness and ability to comply with study requirements.

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. 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.

8. Montreal Cognitive Assessment (MoCA) score < 26 at baseline.

9. 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

10. Known hypersensitivity to DaTscanTM or any of its excipients

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

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

13. 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.
We found this trial at
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Anwar Ahmed, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Arjun Tarakad, MD
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Penelope Hogarth, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Adams Jamie, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Deborah Burke, MD
University of South Florida The University of South Florida is a high-impact, global research university...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Kelvin Chou, MD
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Brian Berman, MD MS
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Matthew Barrett, MD MSC
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Cynthia Poon
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Alberto Espay, MD MSC
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East Lansing, Michigan 48824
Principal Investigator: John L Goudreau, DO PhD
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Las Vegas, Nevada 89106
Principal Investigator: Zoltan Mari, MD
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Kathrin LaFaver, MD
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462 1st Avenue
New York, New York 10010
Principal Investigator: Andrew Feigin, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Meredith Spindler, MD
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Sacramento, California 95817
Principal Investigator: Lin Zhang, MD
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San Francisco, California 94143
Principal Investigator: Tanner Caroline, MD
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Sun City, Arizona 85351
Principal Investigator: David Shprecher, MD
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Winston-Salem, North Carolina 27157
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