Serum Biomarkers in Parkinson's Disease at Different Stages

Parkinson Disease Clinical Trial

Official title:

Serum Biomarkers in Parkinson's Disease at Different Stages

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769699
• Other study ID #: 4687
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2022
• Est. completion date: November 30, 2027

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Giulia Di Lazzaro, MD
• Phone: 0630154303
• Email: giulia.dilazzaro[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2027
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• blood sample
blood sample

Locations

Country	Name	City	State
Italy	Flavia Torlizzi	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Primary	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.	3 years
Primary	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)	3 years