Neuro-Degenerative Disease Clinical Trial
— NeuroInfiamOfficial title:
P2X7 Receptor, Inflammation and Pathophysiology of Neurodegenerative Diseases
NCT number | NCT03918616 |
Other study ID # | AS0002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 20, 2017 |
Est. completion date | March 30, 2019 |
Verified date | August 2019 |
Source | University of Pisa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Parkinson disease (PD) is a chronic degenerative disease characterized by a progressive loss of dopaminergic neurons in the substantia nigra. Its pathophysiological mechanisms are still partially unknown; a main role seems to be played by chronic neuroinflammation. A few reports have addressed the possible involvement of the inflammasome in PD, just describing the protective effect of P2X7 purinergic receptor (P2X7R) blockers in murine models of the disease and in microglial cells, where NLRP3 is activated by α-Synuclein, triggering a neuroinflammation that contributes to degeneration of dopaminergic neurons. It is still unclear whether, in addition to the increased brain expression and function of the nucleotide-binding domain, leucine-rich repeat, pyrin domain containing type 3 (NLRP3) inflammasome platform, a systemic activation of such complex might participate in the pathogenesis of PD, which could be the role of the P2X7R in this scenario, and whether such patterns undergo any specific epigenetic regulation. The present study has been designed to address these issues.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
Inclusion Criteria: - newly-diagnosed PD or AD; - no previous specific treatment; - no systemic inflammatory or immunological disease and/or cancer; - no anti-inflammatory drugs assumed in the three months preceding the enrolment; - patients able to consent. Exclusion Criteria: - history of strokes or any neurological disease; - patients assuming neuroleptic drugs; - atypical symptoms at onset. |
Country | Name | City | State |
---|---|---|---|
Italy | University of Pisa | Pisa |
Lead Sponsor | Collaborator |
---|---|
University of Pisa |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in P2X7R-inflammasome activity | NLRP3-ASC-Caspase-1 activity is measured using RT-PCR | each patient will be assessed one year after diagnosis | |
Primary | Change from baseline in NFkB activity | NFkB activity is measured using RT-PCR | each patient will be assessed one year after diagnosis | |
Primary | Change from baseline in serum a-synuclein | Circulating levels of a-synuclein are determined using high sensitivity Quantikine enzyme-linked immunosorbent assay (ELISA) and express as [ng/ml] | each patient will be assessed one year after diagnosis | |
Primary | Change from baseline in serum IL-1ß | Circulating levels of IL-1ß are determined using high sensitivity Quantikine enzyme-linked immunosorbent assay (ELISA) and express as [pg/ml] | each patient will be assessed one year after diagnosis | |
Primary | Change from baseline in serum IL-18 | Circulating levels of IL-18 are determined using high sensitivity Quantikine enzyme-linked immunosorbent assay (ELISA) and express as [pg/ml] | each patient will be assessed one year after diagnosis | |
Primary | Change from baseline in circulating levels of microRNA miR-30 and miR-7 | Circulating levels of microRNA miR-30 and miR-7 are measured using TaqMan Advanced MicroRNA Assays | each patient will be assessed one year after diagnosis |
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