A Non-interventional Study for the Collection of Biospecimens From Patients With Parkinson's Disease

Study Overview
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Brief Summary
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This study aims to collect, analyze and preserve biospecimens from patients with or without LRRK2-associated Parkinson's Disease for the purpose of discovering and developing new treatments and novel biomarkers.

Official Title
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A Multi-center, Non-interventional Phase 0 Study for the Collection of Biospecimens From Patients With Parkinson's Disease.

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥40 Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria and modified Hoehn and Yahr Stage I, II, or III; Willing to undergo genetic testing for neurologic genotyping panel; -If being treated for Parkinson's disease, must have been on a stable dose of anti- Parkinson's disease medications for a minimum of 30 days prior to Day 1; If taking statins, fibrates, antipsychotic or anticonvulsant medications at Day 1, must have been on a stable dose for a minimum of 30 days, and are not likely to require a change in dosage for the remainder of the study; Exclusion Criteria: Any major medical illness or unstable medical condition within 6 months of screening that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions. Diagnosis of a significant central nervous system disease other than Parkinson's disease(eg, Huntington's disease, frontotemporal dementia, multi-infarct dementia, normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, drug- induced parkinsonism, Alzheimer's disease) History of stroke; History of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or unexpected loss of consciousness (eg, syncope) within 6 months prior to Day 1; History of traumatic brain injury with residual neurological deficit; -If taking anti-Parkinson's disease medication(s)and are likely to require a change in anti- Parkinson's disease medication(s) during the study; Known active infectious disease or active infections within 30 days prior to Day 1; Any vaccination within 21 days prior to Day 1; Currently taking, or planning to take, anti-coagulant medications or antiplatelet medications during the study; Allergy to Lidocaine (xylocaine) or its derivatives or any other LP contraindications; Any other condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject's risk by participating in the study; -Any systemic glucocorticoids taken within 14 days prior to Day 1 or non-steroidal anti- inflammatory drugs taken within 4 days prior to Day 1; Received blood products within 30 days prior to Day 1; Donated blood within 30 days prior to Day 1.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LRRK2 Mutant PD<br>Patients with a G2019S mutation | |
| LRRK2 Wild Type PD Low burden<br>Patients with a low burden of genetic modifiers | |
| LRRK2 Wild Type High burden<br>Patients with a high burden of genetic modifiers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic Marker | Test for LRRK2 mutations in Parkinson disease patients; identifying patients with potential genetic modifiers | 1 day |