Parkinson Disease Clinical Trial
Official title:
Novel and Minimal Invasive Biomarkers for Parkinson's Disease: Profiling of Serum Circulating miRNAs and Patho-physiological Implications
NCT number | NCT03466723 |
Other study ID # | DRPAR01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 14, 2019 |
Est. completion date | June 14, 2022 |
Verified date | March 2023 |
Source | Neuromed IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | June 14, 2022 |
Est. primary completion date | December 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Neuromed IRCCS | Pozzilli | Molise |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of novel circulating miRNAs as biomarkers for Parkinson's disease | The study expects to discover novel circulating miRNAs as biomarkers for Parkinson's disease. As the deep phenotype characterization of the study sample, the project expects to identify new associations of identified miRNAs with disease-related parameters and define the role of miRNAs in the physiological pathways in which those parameters are involved and in the etiology of PD. Also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies | 3 years |
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