search
Back to results

Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Skin biopsy
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects aged 18 years or older Patients with Parkinson's disease, according to the most recent diagnostic criteria Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders Patients with neurological diseases other than Parkinson's disease Inability to sign an informed consent Severe psychiatric diseases

Sites / Locations

  • Flavia TorlizziRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Skin biopsy

Arm Description

Outcomes

Primary Outcome Measures

Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease.
To evaluate the firing frequency in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Biochemical characterization of dopaminergic neurons derived from patients with Parkinson's disease.
To determine the amount of dopamine released from differentiated neurons derived from fibroblasts of patients with Parkinson's disease.
α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinson's disease.
To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

Secondary Outcome Measures

Full Information

First Posted
February 28, 2023
Last Updated
March 21, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
search

1. Study Identification

Unique Protocol Identification Number
NCT05797779
Brief Title
Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease
Official Title
Molecular Characterization of Induced Neuronal Cells Derived From Fibroblasts of Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
March 25, 2025 (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
To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

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
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Skin biopsy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Skin biopsy
Intervention Description
Punch biopsy of the skin
Primary Outcome Measure Information:
Title
Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease.
Description
To evaluate the firing frequency in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Time Frame
Baseline
Title
Biochemical characterization of dopaminergic neurons derived from patients with Parkinson's disease.
Description
To determine the amount of dopamine released from differentiated neurons derived from fibroblasts of patients with Parkinson's disease.
Time Frame
Baseline
Title
α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinson's disease.
Description
To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects aged 18 years or older Patients with Parkinson's disease, according to the most recent diagnostic criteria Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders Patients with neurological diseases other than Parkinson's disease Inability to sign an informed consent Severe psychiatric diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guido Alessandro Primiano, MD
Phone
+390630156433
Email
guidoalessandro.primiano@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

Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

We'll reach out to this number within 24 hrs