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

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ClinicalTrials.gov Identifier: NCT02881099
Recruitment Status : Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : November 1, 2022
Sponsor:
Collaborators:
Parkinson's UK
University of Bristol
Cardiff University
University of Glasgow
Information provided by (Responsible Party):
Dr Donald Grosset, NHS Greater Glasgow and Clyde

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

Condition or disease
Parkinson's Disease

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 Design
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Study Type : Observational
Actual Enrollment : 2614 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)
Study Start Date : February 2012
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
DNA and -80 degrees Centrigrade frozen serum samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's Disease defined by UK Brain Bank criteria Siblings of cases of Parkinson's disease
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881099


Locations
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United Kingdom
Department of Neurology, Queen Elizabeth University Hospital (Co-ordinating Centre)
Glasgow, Scotland, United Kingdom, G51 4DT
Sponsors and Collaborators
South Glasgow University Hospitals NHS Trust
Parkinson's UK
University of Bristol
Cardiff University
University of Glasgow
Investigators
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Study Director: Donald Grosset, BSc, MD Queen Elizabeth University Hospital, Glasgow, UK
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Donald Grosset, Consultant Neurologist, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02881099    
Other Study ID Numbers: GN11NE062
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing agreement in place with University of Oxford, England, and Critical Path Consortium, AZ, US
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases