Wearable Assessments in the Clinic and Home in PD

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.
• •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.