跳至主要内容
临床试验/NCT05159661
NCT05159661招募中不适用

Intelligent Digital Tools for Screening of Brain Connectivity and Dementia Risk Estimation in People Affected by Mild Cognitive Impairment

Oslo University Hospital5 个研究点 分布在 4 个国家目标入组 1,000 人开始时间: 2021年3月1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
1,000
试验地点
5
主要终点
AI-Mind Connector with estimated specificity and sensitivity value > 0.9

研究概览

简要总结

Every three seconds someone in the world develops dementia. There are over 50 million people worldwide living with dementia and by 2030 this figure is expected to reach 82 million. Besides time-consuming patient investigations with low discriminative power for dementia risk, current treatment options focus on late symptom management. By screening brain connectivity and dementia risk estimation in people affected by mild cognitive impairment, the European Union (EU) funded AI-Mind project will open the door to extending the 'dementia-free' period by offering proper diagnosis and early intervention. AI-Mind will develop two artificial intelligence-based digital tools that will identify dysfunctional brain networks and assess dementia risk. Personalised patient reports will be generated, potentially opening new windows for intervention possibilities.

详细描述

The aim of this study is to validate an AI based risk assessment tool for new clinical neurological data management in five clinical centres (Oslo OUS, Helsinki HUH, Madrid UCM, Rome IRCCS and Rome UCSC)). Today, around 50% of patients with mild cognitive impairment (MCI) are at risk to develop dementia, and that early risk signs include brain network disturbances as an expression of beginning synaptic dysfunction in the course of dementia development. This synaptic dysfunction can be registered by electrophysiological brain signals. The AI-Mind Connector will identify such disturbed brain network based on EEG technology. Brain networks patterns are identified among other mathematical possibilities by Graph theory. Classical machine learning and deep learning approaches of artificial intelligence will be used in automating these brain network identification processes in existing M/EEG data.

The secondly developed tool, the AI-Mind Predictor, will serve as an enriched Connector, a multimodal prediction method for risk estimation of dementia in MCI patients. In addition to Connector data, cognitive test results, genetic apolipoprotein E (APOE) allele and P-Tau-protein level information are integrated in the AI-Mind Predictor. The AI-Mind Predictor will discriminate between people at risk for further dementia development and non-at-risk. The anticipated high specific and sensitive AI-Mind Predictor results will be compared to state-of-the-art (SOA) approaches.

The cutting-edge AI-Mind model development and testing will be done by available anonymised and prospective pseudo-anonymised data collected at the 5 included clinical centres. Final adaptation, validation, and prototype development will be conducted by the hereby described collection of prospective data of a total 1000 MCI subjects, based on standardized clinical inclusion/exclusion criteria listed below. All patients will sign an informed consent before entering the study.

The patients will follow the AI-Mind protocol for a 2-year period in parallel with the SOA follow-up procedures at each hospital and country. The protocol includes repetitive M/EEG measurements, digitalised cognitive testing, and at the first visit a blood sample for APOE allele and p-Tau 181 analyses. At two of our clinical centres (HUH and UCM) clinical MEG is additionally offered for specific feature extraction for modelling by new EEG based AI-Mind Connector technology.

Importantly, AI-Mind's new data handling procedure will only use existing well-established, globally accessible and low-cost SOA technologies. With AI-Mind's new data processing approach the goal is to increase today's low predictive value (<0.5) of SOA clinical dementia prediction, and proactively select, with higher accuracy than before, MCI patients at risk to be able to receive earlier clinical intervention. Thereby, AI-Mind wishes to contribute to delaying dementia development by detecting the risk already at the first visit when symptoms occur.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female aged between 60 and 75 years
  • MCI diagnosis with a MMSE >= 25
  • or MCI diagnosis with MoCa >= 17

排除标准

  • Confirmed dementia
  • History of cerebrovascular disease (i.e. stroke episodes)
  • Alcohol Use Disorder Identification Test (AUDIT) score positive
  • Severe medical disorders associated with cognitive impairment (organ insufficiencies, chronic infections, endocrinological disorders)
  • Severe head trauma with structural brain lesion and/or previous brain surgery;
  • Severe mental disorders; Schizophrenia, known Major depression or bipolar disorder
  • Neuroimaging evidence of other potential causes of cognitive decline (e.g. subdural haematoma, malignancy)
  • History of malignancy < 5 years;
  • Recent use of psychotropic drugs including AChEI and Memantine (< 3 months);
  • Participation in trials with experimental drugs.

结局指标

主要结局

AI-Mind Connector with estimated specificity and sensitivity value > 0.9

时间窗: 2026

To validate the AI-Mind Connector as a biomarker for early brain network connectivity disturbance in at-risk patients.

AI-Mind Predictor with estimated specificity and sensitivity value > 0.9.

时间窗: 2026

To validate the AI-Mind Predictor as a diagnostic support tool for dementia risk evaluation. AI-Mind Predictor with higher prediction value for early dementia risk than current clinical practice.

次要结局

  • M/EEG connectivity measures(2026)
  • Clinical utility of Digital Cognitive Test compared to classical Neuropsychological test(2026)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ira Hebold Haraldsen

Principal Investigator

Oslo University Hospital

研究点 (5)

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