Clinical trial NCT06227364: Prediction, Prevention, Predisposition: Applications in Neurology and Endocrinology
Official title: PRE3 PRE-CUBE. PREdiction, PREvention, PREdisposition: Applications in Neurology and Endocrinology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Mild Cognitive Impairment
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies
timeFrame: 1 hour
Secondary outcomes:
measure: Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients
timeFrame: 1 hour
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Irccs Centro Neurolesi Bonino Pulejo
Study officials:
References: