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

I

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status

Enrolling

Conditions

Mild Cognitive Impairment
Dementia

Treatments

Diagnostic Test: metabolic patients
Diagnostic Test: MCI patients

Study type

Observational

Funder types

Other

Identifiers

NCT06227364
PRECUBE2022

Details and patient eligibility

About

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).

Full 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).

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

MCI patients
Description:
patients with mild cognitive impairment submitted to Magnetic Resonance, neuropsychological evaluation, neurological assessment
Treatment:
Diagnostic Test: MCI patients
Metabolic patients
Description:
patietns with obesity and metabollic dysfunction submitted to haematological tests, psychological and neuropsychological evaluations and endocrinology assessment
Treatment:
Diagnostic Test: metabolic patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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