Clinical trial

Novel and Minimal Invasive Biomarkers for Parkinson's Disease: Profiling of Serum Circulating miRNAs and Patho-physiological Implications

Name
DRPAR01
Description
microRNAs (miRNAs) regulate fundamental cell processes. Dysregulation of miRNA expression and function is reported in various diseases including cancer, metabolic disorders as well as neurological disorders. Circulating miRNAs have been proposed to mirror physiological and pathological conditions suggesting their use as biomarkers for various diseases. The study will focus on a case-control study cohort (N=1000) of subjects recruited at the IRCCS Neuromed for which a deep clinical characterization and genome-wide sequencing data are available. This study will enable to identify novel circulating biomarkers for Parkinson's disease (PD). Further, the project will give new insights on the involvement of miRNAs in the etiology of PD and in the understanding of the genetics of the disease thus opening avenues for novel therapeutic strategies.
Trial arms
Trial start
2019-02-14
Estimated PCD
2020-12-14
Trial end
2022-06-14
Status
Completed
Treatment
biomarker identification in Parkinson disease
circulating miRNAs profiling by NGS analysis functional miRNA characterization association of miRNA levels with genetic variants
Size
1000
Primary endpoint
Identification of novel circulating miRNAs as biomarkers for Parkinson's disease
3 years
Eligibility criteria
Inclusion Criteria for cases: * Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa) Exclusion Criteria for cases: * Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders. Exclusion Criteria for controls: Personal or family history for neurodegenerative diseases
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '5 Years', 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA, RNA, Serum'}, 'enrollmentInfo': {'count': 1000, 'type': 'ACTUAL'}}
Updated at
2023-03-23

1 organization

1 product

1 indication

Organization
Neuromed IRCCS