Clinical trial NCT02881099: Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)
Official title: Parkinson's Repository of Biosamples and Network Datasets (Tracking Parkinson's)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: South Glasgow University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Parkinson's UK
name: University of Bristol
name: Cardiff University
name: University of Glasgow
First posted: 2016-08-26
Enrollment: 2614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease defined by UK Brain Bank criteria Siblings of cases of Parkinson's disease

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of participants with Parkinson's who have gene mutations and variations
timeFrame: Up to 36 months
Secondary outcomes:
measure: Categorisation of subtypes of Parkinson's using cluster analysis
timeFrame: At 4 years
measure: Proportion of cases with Parkinson's who have vascular comorbidity and risk factors
timeFrame: At 4 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Glasgow
name: Donald Grosset, BSc, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.