Intelligent Digital Tools for Screening of Brain Connectivity and Dementia Risk Estimation in People Affected by Mild Cognitive Impairment
NCT ID: NCT05159661
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2021-03-01
2026-02-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* MCI diagnosis with a MMSE \>= 25
* or MCI diagnosis with MoCa \>= 17
Exclusion Criteria
* 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.
60 Years
75 Years
ALL
No
Sponsors
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Aalto University
OTHER
Accelopment AG
OTHER
Alzheimer Europe
OTHER
BrainSymph AS
UNKNOWN
Det Norske Veritas
UNKNOWN
Helsinki University Central Hospital
OTHER
IRCCS San Raffaele Roma
OTHER
Lurtis Rules S.L.
UNKNOWN
Neuroconnect Srl
UNKNOWN
Oslo Metropolitan University
OTHER
Radboud University Medical Center
OTHER
Tallinna Ülikool
UNKNOWN
Universidad Complutense de Madrid
OTHER
Catholic University of the Sacred Heart
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Ira Hebold Haraldsen
Principal Investigator
Principal Investigators
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Ira Haraldsen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Helsinki University Hospital
Helsinki, , Finland
Università Cattolica del Sacro Cuore Campus di Roma
Roma, , Italy
Scientific Institute for Research, Hospitalization and Healthcare
Roma, , Italy
Oslo University Hospital
Oslo, , Norway
Universidad Complutense de Madrid
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Offcial project website for the AI-Mind project
Other Identifiers
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204084
Identifier Type: -
Identifier Source: org_study_id
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