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

NCT ID: NCT05761535

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Neurodegenerative Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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neurological disease patients

150 patients with Alzheimer's disease (AD) and Parkinson's disease (PD) for MRI and PET examinations and laboratory medicine

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

Intervention Type 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

Healthy subjects

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

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS SYNLAB SDN

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Synlab SDN

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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6/20

Identifier Type: -

Identifier Source: org_study_id

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