Big Data and Genomic Imaging for the Development of Biomarkers and Nanovector Drugs Innovative for Diagnosis and Therapy of Inflammatory Processes in Dementia

Completed

• Conditions: Neurodegenerative Diseases
• Interventions: Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses

• Registration Number: NCT05761535
• Lead Sponsor: IRCCS SYNLAB SDN

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-17
• Status Verified: 2023-02
• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Primary Completion: 2023-02-28
• Study First Posted: 2023-03-09
• Study Completion: 2023-06-30
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
neurological disease patients	Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses	150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD) for MRI and PET examinations and laboratory medicine
healthy subjects	Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses	Healthy subjects

Primary Outcome Measures

Name	Time	Method
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	1-36 months	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

Trial Locations

Locations (1)

IRCCS Synlab SDN; 🇮🇹 Naples, Italy