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

Sponsor

University College London Hospitals (Other)

Overall Status

Recruiting

CT.gov ID

NCT06151002

Collaborator

Cure Parkinson's (Other)

4,800

Enrollment

Location

246.1

Anticipated Duration (Months)

19.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

4800 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Actual Study Start Date :

Feb 15, 2020

Anticipated Primary Completion Date :

Feb 14, 2025

Anticipated Study Completion Date :

Aug 20, 2040

Outcome Measures

Primary Outcome Measures

Genotype of participants [20 years]
The primary outcome of the study is to genotype the GBA1 gene, obtained with Oxford Nanopore long read sequencing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College London (UCL)	London		United Kingdom	NW3 2PF

Sponsors and Collaborators

University College London Hospitals
Cure Parkinson's

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anthony Schapira, Professor Anthony Schapira, University College London Hospitals

ClinicalTrials.gov Identifier:

NCT06151002

Other Study ID Numbers:

173275

First Posted:

Nov 30, 2023

Last Update Posted:

Nov 30, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Nov 30, 2023