NCT05769699

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
19mo left

Started Feb 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Feb 2022Nov 2027

Study Start

First participant enrolled

February 10, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Expected
Last Updated

March 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

February 28, 2023

Last Update Submit

March 13, 2023

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Biomarkers

EXPERIMENTAL
Procedure: blood sample

Interventions

blood samplePROCEDURE

blood sample

Biomarkers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Women pregnant
  • Inflammatory or autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flavia Torlizzi

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Giulia Di Lazzaro, MD

CONTACT

0630154303giulia.dilazzaro@policlinicogemelli.it

Flavia Torlizzi

CONTACT

0630156433flavia.torlizzi@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 15, 2023

Study Start

February 10, 2022

Primary Completion

December 30, 2023

Study Completion (Estimated)

November 30, 2027

Last Updated

March 15, 2023

Record last verified: 2023-02

Locations

IT(1)