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

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

Study Overview

• Status: Completed
• Conditions: Neurodegenerative Diseases
• Intervention / Treatment: Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80143
    • Irccs Synlab Sdn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
neurological disease patients; 150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD) for MRI and PET examinations and laboratory medicine	Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses; Regarding the neurological MR protocol, the following may be acquired: 3D T1 and T2 high-resolution sequences, acquired in a specific plane and Multiplanar reformation (MPR) reconstructed in the remaining orthogonal planes, for morphological assessment of the different structures under examination;; diffusion sequences for the evaluation of the connection between different areas within a specific organ;; perfusion sequences (ASL, arterial spin labeling) for the evaluation of perfusion without ev mdc administration;; susceptibility sequences for noninvasive assessment of vasculature and deposits of iron.
healthy subjects; Healthy subjects	Radiation: Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses; Regarding the neurological MR protocol, the following may be acquired: 3D T1 and T2 high-resolution sequences, acquired in a specific plane and Multiplanar reformation (MPR) reconstructed in the remaining orthogonal planes, for morphological assessment of the different structures under examination;; diffusion sequences for the evaluation of the connection between different areas within a specific organ;; perfusion sequences (ASL, arterial spin labeling) for the evaluation of perfusion without ev mdc administration;; susceptibility sequences for noninvasive assessment of vasculature and deposits of iron.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS SYNLAB SDN

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases
• Other Study ID Numbers: 6/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No