Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Molecular Characterization of Induced Neuronal Cells Derived From Fibroblasts of Patients With Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797779
• Other study ID #: 3482
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 25, 2025

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Guido Alessandro Primiano, MD
• Phone: +390630156433
• Email: guidoalessandro.primiano[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 25, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects aged 18 years or older

2. Patients with Parkinson's disease, according to the most recent diagnostic criteria

3. 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:

1. Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders

2. Patients with neurological diseases other than Parkinson's disease

3. Inability to sign an informed consent

4. Severe psychiatric diseases

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Skin biopsy
Punch biopsy of the skin

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	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.	Baseline
Primary	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.	Baseline
Primary	a-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.	Baseline