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

Neurodegenerative Diseases Clinical Trial

— BigImAGING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05761535
• Other study ID #: 6/20
• Status: Completed
• Start date: June 17, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: IRCCS SYNLAB SDN
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Dementia
• Neurodegenerative Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Synlab SDN	Naples

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS SYNLAB SDN

Country where clinical trial is conducted

Italy, 

Outcome

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