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

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

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Key information

Conditions

Neurodegenerative Diseases Nervous System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Synlab SDN

Naples, 80143, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance (MR) and positron emission tomograph (PET) imaging analyses

Radiation

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.

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS SYNLAB SDN

Other

Registry information

Acronym: BigImAGING

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Mar 9, 2023
Registry last updated: Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed