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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02881099
Acronym
PRoBaND
Enrollment
2614
Registered
2016-08-26
Start date
2011-11-13
Completion date
2022-12-31
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

None listed

Sponsors

Parkinson's UK
CollaboratorOTHER
University of Bristol
CollaboratorOTHER
Cardiff University
CollaboratorOTHER
University of Glasgow
CollaboratorOTHER
South Glasgow University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

A. Parkinson's Disease patients Inclusion criteria 1. 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') 2. Age ≥18 to \<90years 3. Subject is able and willing to provided informed consent.

Exclusion criteria

1. Patient has severe comorbid illness that would prevent full study participation 2. Patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy 3. Drug-induced parkinsonism (Drug-unmasked PD is allowed) 4. Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed). 5. Negative or normal functional imaging of the presynaptic dopamine system 6. The presence of UK Brain Bank

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants with Parkinson's who have gene mutations and variationsUp to 36 monthsGenotyping for leucine rich repeat kinase 2 (LRRK2), Glucocerebrosidase (GBA) (all cases) and Parkin, Phosphatase and tensin homolog-induced putative kinase 1 (PINK1)(onset\<50years)

Secondary

MeasureTime frameDescription
Categorisation of subtypes of Parkinson's using cluster analysisAt 4 yearsClustering 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.
Proportion of cases with Parkinson's who have vascular comorbidity and risk factorsAt 4 yearsPrior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026