search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Study to investigate mutations in the GBA1 and LRRK2 genes in Parkinson’s Disease patients.


- candidate number27166
- NTR NumberNTR6426
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-mei-2017
- Secondary IDsNL61137.056.17 CHDR1707
- Public TitleStudy to investigate mutations in the GBA1 and LRRK2 genes in Parkinson’s Disease patients.
- Scientific TitleGenetic screening in Parkinson’s Disease in order to identify patients who can participate in clinical trials with new targeted therapies
- ACRONYMGBA1 and LRRK2 screening
- hypothesisGenotyping of the full GBAI gene in people with Parkinson's Disease, assessed as wildtype (GBA-) or containing a mutation (GBA+); the specific mutation will be recorded as well. Assessing the presence of 7 known PD-causing mutations in the LRRK2 gene in people with Parkinson's Disease, assessed as wildtype (LRRK2-) or containing a mutation (LRRK2+); the specific mutation will be recorded as well. Storage of DNA, obtained through saliva, for possible further assessments of genes related to Parkinson's Disease in the future.
- Healt Condition(s) or Problem(s) studiedParkinson
- Inclusion criteria• Signed informed consent prior to any study-mandated procedure
• Diagnosis of Parkinson’s Disease, diagnosed by a neurologist
• Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions
- Exclusion criteriaNA
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 3-apr-2017
- planned closingdate2-mrt-2018
- Target number of participants1000
- InterventionsNA
- Primary outcome• Sequence of the GBA1 gene
• Presence of 7 specific mutations in the LRRK2 gene
- Secondary outcomeDatabase of genotyped PD patients, for future research on PD
- Timepoints• 1x (at home) saliva kit.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD G.J. Groeneveld
- CONTACT for SCIENTIFIC QUERIESMSc Guido van Amerongen
- Sponsor/Initiator CHDR
- Funding
(Source(s) of Monetary or Material Support)
CHDR
- Publications
- Brief summaryFor a upcoming Phase I B study (CHDR1 710), investigating a possible first-in-class disease modifying drug, 28 Parkinson's disease patients with a GBAI mutation (PD-GBA+) are needed. This is a mutation that occurs in approximately 5-10% of PD patients. There is no way to phenotypically differentiate between PD patients with and without a GBAI mutation. ln order to identify these patients, a large-scale screening is needed. Another gene which is known to be involved in the Parkinson's disease process is the LRRK2 gene. This gene is also a possible target for novel treatments, currently being investigated. ln order to perform proof-of-concept or efficacy studies of such treatments, a database of genotyped PD patients is important in order to be able to efficiently enroll a relevant subject population. The patients will be recruited in the Netherlands.
- Main changes (audit trail)
- RECORD3-mei-2017 - 28-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl