Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)

Study Overview
=================
Brief Summary
-----------------
Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.

Detailed Description
-----------------
To identify genetic and biomarker factors which affect the expression of Parkinson's Disease. Primary objective: To define the severity and rates of progression of clinical features of Parkinson's Disease. Secondary objective: To relate clinical phenomenology of Parkinson's disease to genetic and biomarker changes.

Official Title
-----------------
Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
A. Parkinson's Disease patients Inclusion criteria Diagnosis of Parkinson's disease, based on UK Brain Bank criteria and made within the preceding 3 years ('recent onset cases') or diagnosed at under 50 years ('under 50 years cases') Age ≥18 to <90years Subject is able and willing to provided informed consent. Exclusion criteria Patient has severe comorbid illness that would prevent full study participation Patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy Drug-induced parkinsonism (Drug-unmasked PD is allowed) Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed). Negative or normal functional imaging of the presynaptic dopamine system The presence of UK Brain Bank exclusion criteria will be recorded at baseline, allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist Drug used; more than one affected relative) (if justified e.g. by abnormal SPECT). B. First degree relatives Inclusion criteria Age ≥18 to < 90years Resident in the United Kingdom and able to access one of the PRoBaND study centres. Subject is able and willing to provided informed consent. Exclusion criteria Subject has severe comorbid illness that would prevent study participation Subject already has a diagnosis of Parkinson's disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Recent diagnosis (P3)<br>Primary cohort; participants recruited if diagnosed within the last three years | |
| Early diagnosis (P50)<br>Participants recruited if diagnosed before the age of 50 years old | |
| Relatives (R)<br>Siblings of existing participants | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with Parkinson's who have gene mutations and variations | Genotyping for leucine rich repeat kinase 2 (LRRK2), Glucocerebrosidase (GBA) (all cases) and Parkin, Phosphatase and tensin homolog-induced putative kinase 1 (PINK1)(onset<50years) | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorisation of subtypes of Parkinson's using cluster analysis | Clustering of motor and non-motor features measured using Movement Disorder Society Unified Parkinson's disease rating scale (MDS-UPDRS), Montréal cognitive assessment (MoCA), Non-motor symptom Scale (NMSS), Scale for outcomes in Parkinson's autonomic (SCOPA-AUT), Olfaction testing using University of Pennsylvania Smell Identification Test (UPSIT) or Sniffin' sticks, and Leeds anxiety and depression scale (LADS). This will use sequential factor analysis of the results of the above assessments, followed established methods, firstly exploratory factor analysis and secondly confirmatory factor analysis. Factor scores and other clinically important variables will then be combined to construct a single dataset for carrying out the cluster analysis. Hierarchical clustering will then be applied, and models with between 2 and 5 clusters will be described and compared. | At 4 years | 
| Proportion of cases with Parkinson's who have vascular comorbidity and risk factors | Prior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score | At 4 years |