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Serum Biomarkers in Parkinson's Disease at Different Stages

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
blood sample
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Flavia TorlizziRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biomarkers

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 13, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05769699
Brief Title
Serum Biomarkers in Parkinson's Disease at Different Stages
Official Title
Serum Biomarkers in Parkinson's Disease at Different Stages
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
November 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giulia Di Lazzaro, MD
Phone
0630154303
Email
giulia.dilazzaro@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Torlizzi
Phone
0630156433
Email
flavia.torlizzi@policlinicogemelli.it
Facility Information:
Facility Name
Flavia Torlizzi
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Torlizzi
Phone
+390630156433
Email
flavia.torlizzi@policlinicogemelli.it

12. IPD Sharing Statement

Learn more about this trial

Serum Biomarkers in Parkinson's Disease at Different Stages

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