Prediction, Prevention, Predisposition: Applications in Neurology and Endocrinology

NCT06227364 | Unknown

• 1 other identifier: PRECUBE2022
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients

  1 hour

Study Arms (2)

MCI patients

patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment

Diagnostic Test: MCI patients

Metabolic patients

patietns with obesity and metabollic dysfunction submitted to haematological tests, psychological and neuropsychological evaluations and endocrinology assessment

Diagnostic Test: metabolic patients

Interventions

MCI patients DIAGNOSTIC_TEST

patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment

MCI patients

metabolic patients DIAGNOSTIC_TEST

patients with obesity and metabolic dysfunction submitted to haematological tests, psychological and neuropsychological evaluation and endocrinologu assessment

Metabolic patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, 98124, Italy

RECRUITING

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

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

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 26, 2024
• Study Start: March 8, 2023
• Primary Completion: June 30, 2023
• Study Completion: January 21, 2025
• Last Updated: January 26, 2024

Record last verified: 2023-07

Locations

IT (1)