跳至主要内容
临床试验/NCT07731191
NCT07731191招募中不适用

Development of Digital Solutions for the Prediction of the Biological Mechanisms of Alzheimer's Disease Through the Analysis of Risk Factors (PrevAI)

IRCCS Centro San Giovanni di Dio Fatebenefratelli2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2026年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
2
主要终点
Conversion rate to dementia

研究概览

简要总结

Population ageing is one of the main factors responsible for the global increase in the prevalence of dementia. Recent evidence suggests that modifiable risk factors, such as cardiovascular disease and lifestyle, may increase the risk of developing dementia and contribute to its progression. Furthermore, the use of non-invasive plasma biomarkers enables the identification of individuals with neurodegenerative diseases, even in the prodromal stage. However, the relationship between the cumulative burden of risk factors and plasma biomarkers is still poorly understood.

The main objective of this study is to identify and estimate the risk associated with modifiable and non-modifiable predictors (risk factors) linked to the development of Alzheimer's disease (AD) and non-AD dementia, as well as biological alterations consistent with AD or non-AD, through the development of a predictive tool based on Artificial Intelligence algorithms (Machine Learning model). The study also aims to provide a range of technological tools (an app for active patient monitoring and a web platform for clinicians) that could improve risk stratification and the personalisation of care pathways.

The study is divided into two different phases. Firstly, a retrospective phase is conducted in order to construct a predictive model for the risk of dementia and biological alterations consistent with AD. Secondly, a prospective phase is performed for the validation of the predictive model.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female subjects aged more than 18 years at the time of signing the informed consent form;
  • Subjects with MCI or SCD who, at the time of their first visit, did not have a clinical diagnosis of dementia (MMSE ≥ 24);
  • Smartphone user.

排除标准

  • Age younger than that stated in the inclusion criterion;
  • Inability to understand.

结局指标

主要结局

Conversion rate to dementia

时间窗: From enrollment to 3-6 months after enrollment

Risk score that assesses the individual risk associated with predictors linked to (i) the development of AD and non-AD dementia, and (ii) biological biological changes consistent with AD or non-AD pathology.

次要结局

未报告次要终点

研究者

发起方
IRCCS Centro San Giovanni di Dio Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Barbara Borroni

Professor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

研究点 (2)

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