Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease
1 other identifier
interventional
45
1 country
1
Brief Summary
To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Mar 2021
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2021
CompletedFirst Submitted
Initial submission to the registry
February 28, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedApril 4, 2023
February 1, 2023
3.2 years
February 28, 2023
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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.
Baseline
Study Arms (1)
Skin biopsy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Flavia Torlizzi
Roma, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
April 4, 2023
Study Start
March 25, 2021
Primary Completion
June 1, 2024
Study Completion
March 25, 2025
Last Updated
April 4, 2023
Record last verified: 2023-02