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

October 28, 2022 updated by: Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2614

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4DT
        • Department of Neurology, Queen Elizabeth University Hospital (Co-ordinating Centre)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's Disease defined by UK Brain Bank criteria Siblings of cases of Parkinson's disease

Description

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 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

  1. Age ≥18 to < 90years
  2. Resident in the United Kingdom and able to access one of the PRoBaND study centres.
  3. Subject is able and willing to provided informed consent.

Exclusion criteria

  1. Subject has severe comorbid illness that would prevent study participation
  2. Subject already has a diagnosis of Parkinson's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Recent diagnosis (P3)
Primary cohort; participants recruited if diagnosed within the last three years
Early diagnosis (P50)
Participants recruited if diagnosed before the age of 50 years old
Relatives (R)
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
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)
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

At 4 years
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
At 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Donald Grosset, BSc, MD, Queen Elizabeth University Hospital, Glasgow, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data sharing agreement in place with University of Oxford, England, and Critical Path Consortium, AZ, US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

3
Subscribe