A Multicenter Longitudinal Digital Assessment Study of Parkinson Disease Progression in Subjects with Early Untreated Parkinson Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Parkinson's Disease
  • Age: Between 30 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are able to give written consent
    2. Subjects with screening dopamine transporter (DAT) SPECT scan is consistent with dopamine transporter deficit.
    3. Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity; OR either asymmetric resting tremor or asymmetric bradykinesia.
    4. Subjects who are diagnosed with 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
    7. Female subjects of childbearing potential must agree to be using highly effective contraception within 30 days prior to DaTscan
    8. 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
    9. Subjects who are fluent in English and able to read.
    10. Subjects who are able to perform all study activities (including walking tasks and Sit-to-Stand Test).
    11. Willingness and ability to comply with study requirements.

You may not be eligible for this study if the following are true:

    1. Subjects with a diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, primary dystonia or other diagnoses that explain symptoms other than PD.
    2. Subjects who have a 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. Subjects with 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. Subjects who 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. Subjects taking any drugs that might interfere with dopamine transporter SPECT imaging must be willing and able from a medical standpoint to withhold the medication for at least 14 days prior to screening DaTscan imaging.
    8. Subjects Montreal Cognitive Assessment (MoCA) score < 26 at baseline.
    9. Subjects who are pregnant or breastfeeding
    10. Subjects who have known hypersensitivity to DaTscanTM or any of its excipients
    11. Subjects whose body habitus that would impede completion of DaTscan
    12. Subjects who 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.



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