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

Parkinson's Disease Clinical Trial

— PRoBaND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02881099
• Other study ID #: GN11NE062
• Status: Active, not recruiting
• Start date: February 2012
• Est. completion date: January 1, 2024

Study information

• Verified date: October 2022
• Source: South Glasgow University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2614
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United Kingdom	Department of Neurology, Queen Elizabeth University Hospital (Co-ordinating Centre)	Glasgow	Scotland

Sponsors (5)

Lead Sponsor	Collaborator
South Glasgow University Hospitals NHS Trust	Cardiff University, Parkinson's UK, University of Bristol, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At 4 years
Secondary	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	At 4 years