miRNAs Profiling in Parkinson's Disease

NCT03466723 | Completed

• 1 other identifier: DRPAR01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

biomarker identification in Parkinson disease GENETIC

circulating miRNAs profiling by NGS analysis functional miRNA characterization association of miRNA levels with genetic variants

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Collection of 1000 case-control study samples with a large phenotype and genotype characterization. The study includes 500 PD patients and 500 age/gender-matched controls. All PD patients have been diagnosed at the IRCCS Neuromed and followed-up (at least for 5 years) for disease progression. Data collected from patients and unrelated controls include: socio-demographic status, life style, anamnesis and family history, exposure to toxic chemical and/or environmental agents. Patients have been studied with a protocol comprising neurological examination (Stadio di Hoehn and Yahr, MDS-UPDRS part III, MOCA test) and evaluation of no motor symptoms. Information about drugs therapy have been also collected.

You may qualify if:

• 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)

You may not qualify if:

• 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.
• Personal or family history for neurodegenerative diseases

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

Neuromed IRCCS

Pozzilli, Molise, 86077, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA, RNA, Serum

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Daniela Ruggiero, Ph.D.

  Neuromed IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: February 14, 2019
• Primary Completion: December 14, 2020
• Study Completion: June 14, 2022
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

IT (1)