Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Procedure: Skin biopsy

• Registration Number: NCT05797779
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-25
• Status Verified: 2023-02
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04
• Primary Completion: 2024-06-01
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin biopsy	Skin biopsy	-

Primary Outcome Measures

Name	Time	Method
Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease.	Baseline	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.	Baseline	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.	Baseline	To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

Trial Locations

Locations (1)

Flavia Torlizzi; 🇮🇹 Roma, Italy