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A research study to find an indicator of Parkinson’s Disease in blood, urine or spinal fluid using Healthy Volunteers and Parkinson’s Disease patients.

Recruiting
Conditions
Parkinson’s Disease
Registration Number
NL-OMON20075
Lead Sponsor
Denali Therapeutics
Brief Summary

A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
35
Inclusion Criteria

Groups A and B

1. Confirmed clinical diagnosis of Parkinson’s disease by a qualified neurologist,

Exclusion Criteria

8.Exclusion Criteria

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
- LRRK2 phosphorylation (pS935, total LRRK2 and pS935/Total LRRK2 ratio) in<br> PBMCs, Whole blood, Neutrophils, Urine exosomes, CSF exosomes.<br><br /><br /><br>- Rab GTPase phosphorylation in PBMCs, whole blood, Neutrophils, Urine exosomes, CSF exosomes, lipidomic, metabolomic and/or proteomic analysis of CSF Urine and/or Plasma. <br /><br /><br><br>- CSF lysosomal enzyme activity, Cathepsin D, Glucocerebrosidase.<br><br /><br /><br>- CSF alpha-synuclein, Total, pS129 and/or Oligomeric alpha-synuclein. <br><br /><br /><br>- CSF and plasma cytokines (65-cytokine panel)<br><br /><br /><br>- Cellular analyses of fibroblast cultures, e.g. lysosome imaging, immunohistochemistry for lysosome markers (LAMP1, LAMP2, etc), lysotracker, LRRI€pS93S and pRabl0 immunoassays, LC/MS analysis, protein turnover analysis, and Lysosome enzyme activity assays.<br /><br /><br><br>- Potential other parameters related to LRRK2 that become available<br>
Secondary Outcome Measures
NameTimeMethod
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