Fox Investigation for New Discovery of Biomarkers (BioFIND)

Parkinson's disease and healthy control subjects

Inclusion Criteria (PD Subjects):

• Subjects must have bradykinesia and rigidity.
• Current or history of well documented resting tremor.
• Unilateral onset or persistent asymmetry.
• A well established response to dopaminergic agents including the presence of levodopa induced dyskinesia for at least 3 years according to treating physician's judgment.
• Subject has progressive PD of 5 to 15 years of duration from the onset of symptoms.
• Male or female age of onset of PD 50 to 70 by history. Current ages would range from 55 to 85 based on #5 and #6 requirements.
• Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
• Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Exclusion Criteria (PD Subjects):

• Family history of PD in first degree relatives.
• Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
• Has others serious neurological disorders (clinically significant stroke, brain tumor, hydrocelphalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
• Has early severe autonomic involvement. Symptomatic orthostatic, hypotension or urinary incontinence within one year of onset of disease symptom.
• Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
• Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
• Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
• Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
• Has lower body predominant symptoms.
• Has supra-nuclear gaze palsy, CG sign, corticospinal track signs.

Inclusion Criteria (HC Subjects):

• Male or female age 55 to 85 years or older at visit 1.
• Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
• Willing and able to comply with scheduled visits, required study procedures and laboratory tests.

Exclusion Criteria (HC Subjects):

• Family history of PD in first degree relatives.
• Ashkenazi Jewish subject (defined as all 4 grandparents being Ashkenazi Jewish) will be excluded because of the high likelihood of genetic forms of PD (LRRK2) and GBA), unless these have been already excluded by genetic testing.
• Has other serious neurological disorders (clinically significant stroke, brain tumor, hydrocelphalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma).
• Has a history of cancer, autoimmune disorder, liver disease, or hematological disorders within the past 5 years.
• Has early severe autonomic involvement: symptomatic orthostatic hypotension or urinary incontinence within one year of onset of disease symptom.
• Current treatment with anticoagulants (e.g., Coumadin, heparin) that might preclude safe completion of the lumbar puncture.
• Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
• Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
• Use of investigational drugs or devices within 60 days prior to baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
• MoCA score <26.