Parkinson's DiseasePRoBaNDNCT02881099
Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust.
Trial summary
Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 2,614 participants
- Where
- No sites listed yet
- Study dates
- 13 Nov 2011to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's Disease defined by UK Brain Bank criteria Siblings of cases of Parkinson's disease
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- Subject has severe comorbid illness that would prevent study participation
- Subject already has a diagnosis of Parkinson's disease
About this study
Prospective observational study of Parkinson's disease with repeat clinical assessment and biobanking of blood samples.
Read the 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.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Parkinson's who have gene mutations and variations
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)
Measured: Up to 36 months
Secondary outcomes (2)
Categorisation of subtypes of Parkinson's using cluster analysis
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.
Measured: At 4 years
Proportion of cases with Parkinson's who have vascular comorbidity and risk factors
Prior history of vascular events, or calculated using Quantification of Risk version 2 (QRISK2) vascular risk score
Measured: At 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start13 Nov 2011
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,614 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Glasgow University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's UK, University of Bristol, Cardiff University, University of Glasgow
- Responsible party
- Principal investigator, Dr Donald Grosset, University of Glasgow
- Investigators
- Donald Grosset, BSc, MD, Study director, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881099
- Sponsor's protocol ID
- GN11NE062
- Acronym
- PRoBaND
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2013
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data sharing will be managed to Data \& Biosample Access Committee and through direct partnerships with organisations.
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.
PubMed 29378790Swallow 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.
PubMed 27671901
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)
- ClinicalTrials.gov ID
- NCT02881099
- Acronym / sponsor ID
- PRoBaND / GN11NE062
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,614 participants (actual)
- Lead sponsor
- South Glasgow University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Parkinson's UK, University of Bristol, Cardiff University, University of Glasgow
- Study start
- 13 Nov 2011 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's Disease defined by UK Brain Bank criteria Siblings of cases of Parkinson's disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
2 secondary outcomes
Categorisation of subtypes of Parkinson's using cluster analysis
Time frame: At 4 years
Proportion of cases with Parkinson's who have vascular comorbidity and risk factors
Time frame: At 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 29378790Malek 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.
- Derived from this study: PubMed 27671901Swallow 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.
- Individual participant dataSharing planned: Yes. Data sharing will be managed to Data \& Biosample Access Committee and through direct partnerships with organisations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Grosset, BSc, MD study director
University of Glasgow
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Parkinson's who have gene mutations and variations (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.