A Novel Measurement Concept to Objectively Quantify Severity of Vocal and Speech Related Symptoms Associated With Parkinson's Disease

Prior treatment

• History of drug and/or alcohol abuse within the past year prior to Screening Visit.
• Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
• History of drug and/or alcohol abuse within the past year prior to Screening Visit.
• Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
• History of drug and/or alcohol abuse within the past year prior to Screening Visit.

Other illness

• Symptomatic or atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).
• Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator).
• Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
  • Prodromal PD:
• Clinical diagnosis of PD, other parkinsonism, or dementia.
• Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
• Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
• Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation

Age

• Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
  • Age \& Sex Matched Healthy Control:

Other

• PD:
• Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit
• Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
• Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
• First degree relative with PD (i.e., biologic parent, sibling, child).
• Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.

• PD:
• Male or female age 30 years or older at Screening Visit.
• Diagnosis of PD as defined by MDS PD diagnostic criteria \[1\]
• PD severity at Screening Visit of either:
  • PD Hoehn and Yahr Stage 1-2, inclusive (PD Cohort I)
  • PD Hoehn and Yahr Stages 3-4, inclusive (PD Cohort II)
• Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments.
• Able to provide informed consent.
  • Prodromal PD:
• Confirmation that participant is eligible based on clinician determined predictive criteria of known risk of PD including
  • Rapid eye movement sleep behavior disorder (RBD), possible, probable or definite, OR
  • Hyposmia defined as less than 10th percentile on University of Pennsylvania Smell Identification Test (UPSIT), age and gender adjusted, OR
  • Known genetic variants associated with PD risk, AND Confirmed eligible DAT scan.
• Male or female age 30 or older at Screening Visit.
• Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
• Able to provide informed consent.
  • Age \& Sex Matched Healthy Control:
• Male or female age 30 years or older at Screening visit.
• Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
• Able to provide informed consent.