PRE3 PRE-CUBE. PREdiction, PREvention, PREdisposition: Applications in Neurology and Endocrinology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
the creation of predictive algorithms capable of calculating the risk of onset and/or staging of neurodegenerative and metabolic pathologies
时间窗: 1 hour
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.
次要结局
- Evaluate the effectiveness of the therapeutic path and define the outcomes of the treatment plan for these types of patients(1 hour)