PD Frontline (Part of RAPSODI GD) Remote Assessment of People With Parkinson's

Parkinson Disease Clinical Trial

— PD Frontline  

Official title:

PD Frontline, Part of RAPSODI GD (Remote Assessment of Parkinsonism Supporting Ongoing Development of Interventions in Gaucher's Disease) to Build an Online Trial-ready Cohort of GBA Genotyped People With Parkinson's

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151002
• Other study ID #: 173275
• Status: Recruiting
• Start date: February 15, 2020
• Est. completion date: August 20, 2040

Study information

• Verified date: November 2023
• Source: University College London Hospitals
• Contact: Orla Mitchell
• Phone: 020 801 68413
• Email: pdfrontline[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

PD Frontline (part of RAPSODI GD) is an online study observational study with the goal of bringing People with Parkinson's to the frontline of research by getting them trial ready. To do this, participants are offered genetic sequencing for the GBA and LRRK2 gene with an at-home saliva collection kit.

Description:

PD Frontline is an online one-time questionnaire based study with the purpose of identifying potential candidates for gene targeted trials and observational studies. Once the questionnaire is completed, the participant is sent a saliva collection kit in the post to provide a sample for genetic testing. The genes tested for are GBA1, the most common risk factor gene for Parkinson's, and LRRK2. Once tested, the participant is informed of their results and kept up-to-date with any studies or trials for which they may be eligible.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4800
• Est. completion date: August 20, 2040
• Est. primary completion date: February 14, 2025
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Formal diagnosis of Parkinson Disease

Exclusion Criteria:

• Confirmation that the individual carries a GBA variant (GBA positive). These individuals will be referred to sister-study, RAPSODI.
• History of Parkinsonism (progressive supranuclear palsy, multiple system atrophy, traumatic, manganese toxicity, postencephalitic, vascular PD; drug induced PD; corticobasal degeneration)
• Individuals with another neurological disorder including: dementia, movement disorders, and motor neurone disease.
• Individuals on drugs known to be associated with parkinsonism, including neuroleptic agents (Amisulpride, Chlorpromazine Hydrochloride, Flupenthixol, Fluphenazine Hydrochloride, Haloperidol, Methotrimeprazine, Levomepromazine, Olanzapine, Oxypertine, Pericyazine, Perphenazine, Pimozide, Pipotiazine, Prochlorperazine, Promazine Hydrochloride, Reserpine, Risperidone, Sulpiride, Thioridazine, Trifluoperazine, Zuclopenthixol acetate, Zotepine), plus Bupropion, , Lithium, Methyldopa, Metoclopramide and Sodium Valproate).

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
United Kingdom	University College London (UCL)	London

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	Cure Parkinson's

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotype of participants	The primary outcome of the study is to genotype the GBA1 gene, obtained with Oxford Nanopore long read sequencing.	20 years