Molecular Pathology and Neuronal Networks in LRRK2 Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03782753|
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : January 27, 2020
Parkinson's Disease (PD) is a progressive neurodegenerative disease characterized clinically by bradykinesia, resting tremor, rigidity, and postural instability. Little is known about the mechanisms underlying neuronal degeneration in PD and currently, no treatment is available to halt disease progression in PD.
The pathophysiological characterisation of phenomena occurring in the time window between the pathological start of the disease and the onset of motor symptoms is crucial to develop potential neuroprotective agents.
Several genes have been discovered providing important insights on the pathogenesis of PD. Mutations of Leucine-rich repeat kinase 2 (LRRK2) are associated with 2-5% of all PD cases in North American Caucasians. LRRK2 is an enzyme that in humans is encoded by the autosomal dominant Parkinson's disease-8 (PARK8) gene, which is associated with an increased risk of PD.
Clinical and digital biomarkers, blood and cerebrospinal fluid (CSF) biomarkers and molecular positron emission tomography (PET) imaging, with specific radioligands, provide invaluable insights to help understand and characterise disease pathophysiology.
The investigators aim to characterize molecular phenomena underlying LRRK2 PD with the hope of providing further insights into possible mechanisms taking place in PD and to help identify targets for disease-modifying therapeutics.
|Condition or disease|
|Parkinson Disease, PARK8 Parkinson Disease Idiopathic Parkinson Disease|
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Longitudinal Study of Molecular Pathology and Neuronal Networks in Leucine-rich Repeat Kinase 2 Carriers and Idiopathic Parkinson's Disease Patients and Healthy Controls Using PET, MR Imaging, and Other Markers of in Vivo Pathology|
|Actual Study Start Date :||February 15, 2019|
|Estimated Primary Completion Date :||January 14, 2021|
|Estimated Study Completion Date :||January 14, 2021|
25 LRRK2-PD patients
25 idiopathic PD patients
25 HC subjects
- Changes in serotonergic transmission in the ventral and dorsal raphe nuclei, and in raphe projection areas, in LRRK2-PD compared to idiopathic PD. [ Time Frame: One year ]The study's main outcome measure is changes in serotonergic neurotransmission within specific brain regions. This will be assessed with positron emission tomography (PET) imaging using the readioligand 11C-labeled 3-amino-4 -(2-dimethylaminomethyl-phenylsulfanyl)benzonitrile ([11C]DASB).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782753
|Contact: Silvia Rota, MD MScfirstname.lastname@example.org|
|Contact: Lucia Batzu, MD MScemail@example.com|