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

NCT05761535 | Completed

• 1 other identifier: 6/20
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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

Conditions

Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

healthy subjects

Healthy subjects

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

Interventions

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.

healthy subjects; neurological disease patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All subjects of either sex aged 18 to 85 years who are able to provide voluntary consent, suffering from neurodegenerative diseases (AD and PD)

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead

Study Sites (1)

IRCCS Synlab SDN

Naples, 80143, Italy

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Interventions

Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: June 17, 2020
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2023
• Last Updated: March 25, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)