Prediction, Prevention, Predisposition: Applications in Neurology and Endocrinology (PRECUBE2022)

PRE3 PRE-CUBE. PREdiction, PREvention, PREdisposition: Applications in Neurology and Endocrinology

This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.

Study design

Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.

All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).

Study Overview

• Status: Recruiting
• Conditions: Dementia; Mild Cognitive Impairment
• Intervention / Treatment: Diagnostic test: MCI patients; Diagnostic test: metabolic patients

Detailed Description

This project aims to introduce solutions for strengthening the management capabilities of two types of patients, in terms of care and prevention. Specifically, it is aimed at neurological patients with mild or minor neurocognitive decline (Mild Cognitive Impairment, MCI) and endocrinological patients diagnosed with obesity. The study want to enhance the predictive capacity of the care process management system through an Artificial Intelligence (AI) system. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.

Study design

Patients will not be subjected to any procedure that goes beyond normal clinical practice; the clinical and neuropsychological variables that will be collected for the study are those that are commonly collected in normal clinical practice. All patients diagnosed with MCI and obesity who, within 30 months, will be referred to the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina will be evaluated.

All patients will undergo clinical, neuropsychological and psychological evaluation at the beginning (baseline T0), at the end (T1) and after ... months from the end of treatment (follow up T2).

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • Recruiting
    • Irccs Centro Neurolesi Bonino Pulejo
    • Contact: silvia marino, dr; Phone Number: +3909060128110; Email: silvia.marino@irccsme.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

N 100 patients diagnosed with MCI and N 100 patients with BMI > 30 kg/m² with or without comorbidities, coming from the external basin, family doctors or other specialists, will be recruited at the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino Pulejo of Messina.

Description

Inclusion Criteria:

For MCI patients:

Patients aged between 18 and 80 years; Clinical and instrumental diagnosis of MCI, according to the normal clinical practice adopted; Written informed consent obtained from the patient;

For Metabolic patients:

Age: >18 years BMI > 30 kg/m²

Willingness to follow requests as per protocol, including:

Signing an informed consent. Participation in scheduled follow-up visits. Carrying out instrumental and laboratory tests

Exclusion Criteria:

For MCI patients:

age under 40 other concomitant neurological and/or psychiatric condition drug abuse unstable clinical conditions requiring acute hospitalization.

For Metabolic patients:

unstable clinical conditions requiring acute hospitalization. associated serious pathologies and/or with reduced life expectancy, including renal failure under dialysis treatment, liver cirrhosis, malignant neoplasms, NYHA class III-IV heart failure, chronic respiratory failure under oxygen therapy.

psychological or psychiatric conditions that may reduce study cooperation.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MCI patients; patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment	Diagnostic test: MCI patients; patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment
Metabolic patients; patietns with obesity and metabollic dysfunction submitted to haematological tests, psychological and neuropsychological evaluations and endocrinology assessment	Diagnostic test: metabolic patients; patients with obesity and metabolic dysfunction submitted to haematological tests, psychological and neuropsychological evaluation and endocrinologu assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies	The project has as its primary objective the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies, with the aim of identifying potential targets of subjects at risk of developing such diseases, in the context of patient enrollment, as per normal clinical practice, on an outpatient basis, at our IRCCS.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients	Consider the macro-tasks relating to Taking Charge, Activation of the therapeutic, care and rehabilitation plan as well as the activation of care and follow-up services. With these macro-tasks, through an analysis of the data, it will be possible to carry out an evaluation of the effectiveness of the treatment path envisaged for the patient, identify the treatment process that follows the adopted PDTA (taking charge, evaluation, monitoring and follow-up up) and define the outcomes of the treatment plan for these types of patients, promoting a correct diagnostic classification and an effective therapeutic intervention aimed at managing comorbidities and improving the patients' quality of life.	1 hour

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): January 21, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Disease Attributes; Cognition Disorders; Cognitive Dysfunction; Disease Susceptibility
• Other Study ID Numbers: PRECUBE2022

Drug and device information, study documents

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