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

NCT02881099 | Completed DMC

• 1 other identifier: GN11NE062
• Study Type: observational
• Target: 2,614
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  Up to 36 months

Secondary Outcomes (2)

• Categorisation of subtypes of Parkinson's using cluster analysis

  At 4 years

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

  At 4 years

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• South Glasgow University Hospitals NHS Trust: lead
• Parkinson's UK: collaborator
• University of Bristol: collaborator
• Cardiff University: collaborator
• University of Glasgow: collaborator

Related Publications (2)

• 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.

  PMID: 29378790 DERIVED

• 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.

  PMID: 27671901 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA and -80 degrees Centrigrade frozen serum samples

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Donald Grosset, BSc, MD

  University of Glasgow

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Fellow

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: August 26, 2016
• Study Start: November 13, 2011
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data \& Biosample Access manage applications for access for the duration of the grant until 31 December 2023, after which point data will be accessible to researchers through other bodies, including Critical Path for Parkinson's and Global Parkinson's Genetics Program.
• Access Criteria: https://c-path.org/programs/cpp/ https://gp2.org/