Neurodegenerative Diseases Clinical Trial
— BigImAGINGOfficial title:
Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia
NCT number | NCT05761535 |
Other study ID # | 6/20 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 17, 2020 |
Est. completion date | June 30, 2023 |
Verified date | February 2023 |
Source | IRCCS SYNLAB SDN |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The correlation between data obtained by "imaging" in patients with neurodegenerative diseases characterized by inflammation and the presence in the peripheral blood of the same patients "biopsies liquid biopsies" of specific circulating nucleic acids, could enable the development of methods and algorithms capable of identifying novel biomarkers that serve as targets for the development of probes diagnostics and therapeutics. This is the context for the project idea, which is aimed at developing development of a performant multi parameter system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease
Status | Completed |
Enrollment | 137 |
Est. completion date | June 30, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: All subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD) Exclusion Criteria: All patients for whom there are contraindications to performing MRI. Also excluded from the study will be subjects who are pregnant, or presumed to be pregnant or undergoing of lactation and subjects with claustrophobia |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Synlab SDN | Naples |
Lead Sponsor | Collaborator |
---|---|
IRCCS SYNLAB SDN |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of a performant multiparametric system capable of identifying novel biomarkers of microglial polarization that can be used for diagnostic and prognostic purposes in determining the staging/progression of neurodegenerative disease | Collection and processing of multimodal imaging data and biological samples in patients with Dementia; Development of the Informatics Platform to support the interpretation of data in clinical setting | 1-36 months |
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