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Completed

NCT Number: NCT02881099

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

Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of participants with Parkinson's who have gene mutations and variations

    Time frame: Up to 36 months

    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)

Secondary outcomes

  1. Categorisation of subtypes of Parkinson's using cluster analysis

    Time frame: At 4 years

    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.

  2. Proportion of cases with Parkinson's who have vascular comorbidity and risk factors

    Time frame: At 4 years

    Prior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score

Sponsors and collaborators

Lead sponsor

South Glasgow University Hospitals NHS Trust

Other

Collaborators

  • Cardiff University
  • Parkinson's UK
  • University of Bristol
  • University of Glasgow

Registry information

Acronym: PRoBaND

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2016
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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