Serum Biomarkers in Parkinson's Disease at Different Stages

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05769699
Collaborator
(none)
200
1
1
69.6
2.9

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: blood sample
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Serum Biomarkers in Parkinson's Disease at Different Stages
Actual Study Start Date :
Feb 10, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Nov 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Biomarkers

Procedure: blood sample
blood sample

Outcome Measures

Primary Outcome Measures

  1. Determine clinical characteristics of parkinsonian patients in various stages of disease [3 years]

    Determine clinical characteristics of parkinsonian patients in various stages of disease by means of MDS-UPDRS score changes.

  2. Determine clinical characteristics of parkinsonian patients in various stages of disease [3 years]

    Determine clinical characteristics of parkinsonian patients in various stages of disease by means of NMS score changes.

  3. Determine biooogical characteristics of parkinsonian patients in various stages of disease [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Flavia Torlizzi Roma Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05769699
Other Study ID Numbers:
  • 4687
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2023