- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02881099
Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's) (PRoBaND)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Scotland
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Glasgow, Scotland, United Kingdom, G51 4DT
- Department of Neurology, Queen Elizabeth University Hospital (Co-ordinating Centre)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Recent diagnosis (P3)
Primary cohort; participants recruited if diagnosed within the last three years
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Early diagnosis (P50)
Participants recruited if diagnosed before the age of 50 years old
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Relatives (R)
Siblings of existing participants
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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
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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)
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Up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Categorisation of subtypes of Parkinson's using cluster analysis
Time Frame: At 4 years
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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
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Proportion of cases with Parkinson's who have vascular comorbidity and risk factors
Time Frame: At 4 years
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Prior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score
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At 4 years
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Collaborators and Investigators
Investigators
- Study Director: Donald Grosset, BSc, MD, Queen Elizabeth University Hospital, Glasgow, UK
Publications and helpful links
General Publications
- Malek N, Weil RS, Bresner C, Lawton MA, Grosset KA, Tan M, Bajaj N, Barker RA, Burn DJ, Foltynie T, Hardy J, Wood NW, Ben-Shlomo Y, Williams NW, Grosset DG, Morris HR; PRoBaND clinical consortium. Features of GBA-associated Parkinson's disease at presentation in the UK Tracking Parkinson's study. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):702-709. doi: 10.1136/jnnp-2017-317348. Epub 2018 Jan 29.
- Swallow DM, Lawton MA, Grosset KA, Malek N, Klein J, Baig F, Ruffmann C, Bajaj NP, Barker RA, Ben-Shlomo Y, Burn DJ, Foltynie T, Morris HR, Williams N, Wood NW, Hu MT, Grosset DG. Statins are underused in recent-onset Parkinson's disease with increased vascular risk: findings from the UK Tracking Parkinson's and Oxford Parkinson's Disease Centre (OPDC) discovery cohorts. J Neurol Neurosurg Psychiatry. 2016 Nov;87(11):1183-1190. doi: 10.1136/jnnp-2016-313642. Epub 2016 Sep 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN11NE062
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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