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

Eligibility Criteria

• 1. Male or female age 30 years or older at Screening Visit.
• 2. Diagnosis of PD as defined by MDS PD diagnostic criteria \[1\]
• 3. 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)
• 4. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments.
• 5. Able to provide informed consent.
• 1. Confirmation that participant is eligible based on clinician determined predictive criteria of known risk of PD including
• 1. Rapid eye movement sleep behavior disorder (RBD), possible, probable or definite, OR
• 2. Hyposmia defined as less than 10th percentile on University of Pennsylvania Smell Identification Test (UPSIT), age and gender adjusted, OR
• 3. Known genetic variants associated with PD risk, AND Confirmed eligible DAT scan.
• 2. Male or female age 30 or older at Screening Visit.
• 3. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
• 4. Able to provide informed consent.
• 1. Male or female age 30 years or older at Screening visit.
• 2. Able and willing to complete all aspects of the study, including at home smartphone app and Zoom telehealth assessments
• 3. Able to provide informed consent.
• 1. Late-stage PD diagnosis (i.e., Hoehn \& Yahr Stage 5) at Screening Visit
• 2. 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).
• 3. Current or active clinically significant neurological disorder other than PD (in the opinion of the Investigator).
• 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
• 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
• 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
• 1. Clinical diagnosis of PD, other parkinsonism, or dementia.
• 2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
• 3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
• 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
• 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
• 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation.
• 1. First degree relative with PD (i.e., biologic parent, sibling, child).
• 2. Any current or active clinically significant neurological disorder (in the opinion of the Investigator).
• 3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
• 4. Significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation.
• 5. History of drug and/or alcohol abuse within the past year prior to Screening Visit.
• 6. Inability or unwillingness to complete all aspects of the study - including use of a provisioned smartphone for study assessments; completion of telehealth assessments.
• 7. Any other medical or psychiatric condition, which in the opinion of the investigator might preclude participation