Improving care for patients with mild cognitive impairment and obesity using AI

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

This study is testing whether using an AI system can help improve the care of people with mild cognitive impairment and obesity by making their treatment more effective.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo (Academic / other)
• Locations: 1 site (Messina)
• Trial ID: NCT06227364 on ClinicalTrials.gov

What this trial studies

This project focuses on enhancing the management of patients with Mild Cognitive Impairment (MCI) and obesity by utilizing an Artificial Intelligence (AI) system to improve predictive capabilities in their care processes. Patients diagnosed with MCI and obesity will be evaluated at the Neurology and Endocrinology clinics of the IRCCS Centro Neurolesi Bonino-Pulejo in Messina over a 30-month period. The study will collect clinical, neuropsychological, and psychological data at baseline, at the end of the evaluation, and during follow-up, without subjecting patients to any procedures beyond standard clinical practice.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-80 diagnosed with Mild Cognitive Impairment or obesity (BMI > 30 kg/m²).

Not a fit: Patients with unstable clinical conditions requiring acute hospitalization or those with serious associated pathologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and preventive strategies for patients with MCI and obesity.

How similar studies have performed: While the use of AI in healthcare is gaining traction, this specific approach targeting MCI and obesity is relatively novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Messina

• Irccs Centro Neurolesi Bonino Pulejo — Messina, Italy (Recruiting)

Conditions Dementia; Mild Cognitive Impairment