Serum Biomarkers in Parkinson's Disease at Different Stages

March 13, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Determine clinical characteristics of parkinsonian patients in various stages of disease;
  • Measure peripheral neurodegeneration, synaptic, and inflammation biomarkers in a population of parkinsonian patients at various stages of disease.
  • Measure vesicular neurodegeneration, synaptic and inflammation biomarkers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with idiopathic PD according to Movement Disorders Society (MDS) criteria;
  • Age: 18-80 years;
  • Signature of informed consent to participate in this study

Exclusion criteria.

  • Women pregnant
  • Inflammatory or autoimmune diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biomarkers
Procedure: blood sample
blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine clinical characteristics of parkinsonian patients in various stages of disease
Time Frame: 3 years
Determine clinical characteristics of parkinsonian patients in various stages of disease by means of MDS-UPDRS score changes.
3 years
Determine clinical characteristics of parkinsonian patients in various stages of disease
Time Frame: 3 years
Determine clinical characteristics of parkinsonian patients in various stages of disease by means of NMS score changes.
3 years
Determine biooogical characteristics of parkinsonian patients in various stages of disease
Time Frame: 3 years
dosage of serum IL-1b, IL6, IL-5, IL-4, IL17, TNFa, IFNg, IL10, total-alpha-synuclein, NfL, BDNF (ng/ml for all)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

November 30, 2027

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4687

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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