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

November 28, 2023 updated by: Anthony Schapira, University College London Hospitals

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

4800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, NW3 2PF
        • Recruiting
        • University College London (UCL)
        • Contact:
        • Principal Investigator:
          • Tony Schapira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Randomly selected population, recruited via established NHS sites and self-referral to the website.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype of participants
Time Frame: 20 years
The primary outcome of the study is to genotype the GBA1 gene, obtained with Oxford Nanopore long read sequencing.
20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Collaborators

Cure Parkinson's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Estimated)

February 14, 2025

Study Completion (Estimated)

August 20, 2040

Study Registration Dates

First Submitted

October 11, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173275

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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