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

NCT05159661 | Recruiting

• 1 other identifier: 204084
• Study Type: observational
• Target: 1,000
• Locations: 4 countries
• Sites: 5

Brief Summary

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.

Conditions

Cognitive Dysfunction; Dementia; Mild Cognitive Impairment

Keywords

MCI; AI; EEG; Alzheimer; Dementia; Functional brain connectivity; Deep learning; Machine learning

Outcome Measures

Primary Outcomes (2)

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

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

  2026

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

  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.

  2026

Secondary Outcomes (2)

• Clinical utility of Digital Cognitive Test compared to classical Neuropsychological test

  2026

• M/EEG connectivity measures

  2026

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 1000 MCI participants will be screened and consecutively enrolled at AI-MINDs by the clinical criteria and assessments. All patients will be enrolled by SOA procedures being referred to neurological and memory clinics due to their mild cognitive impaired symptoms. Subjects that fulfil the AI-Mind criteria for MCI based on the acknowledged criteria by the National Institute on Aging-Alzheimer's Association (NIA-AA), and meet the projects inclusion criteria listed below, will be offered to participate in the AI-Mind clinical study. The clinical identification of MCI is defined using specific assessment tools known to accurately identify cognitive status and progression of cognitive decline. The assessment tools include the use of Mini Mental State Examination (MMSE), Clinical Dementia Rating (CDR), Instrumental activities of daily living IADL and Petersen/Winblad criteria with 1.5 SD in 1 or more cognitive domains.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Aalto University: collaborator
• Accelopment AG: collaborator
• Alzheimer Europe: collaborator
• BrainSymph AS: collaborator
• Det Norske Veritas: collaborator
• Helsinki University Central Hospital: collaborator
• IRCCS San Raffaele Roma: collaborator
• Lurtis Rules S.L.: collaborator
• Neuroconnect Srl: collaborator
• Oslo Metropolitan University: collaborator
• Radboud University Medical Center: collaborator
• Tallinna Ülikool: collaborator
• Universidad Complutense de Madrid: collaborator
• Catholic University of the Sacred Heart: collaborator

Study Sites (5)

Helsinki University Hospital

Helsinki, 00280, Finland

RECRUITING

Università Cattolica del Sacro Cuore Campus di Roma

Roma, 00168, Italy

RECRUITING

Scientific Institute for Research, Hospitalization and Healthcare

Roma, 00179, Italy

RECRUITING

Oslo University Hospital

Oslo, 0450, Norway

RECRUITING

Universidad Complutense de Madrid

Madrid, 28040, Spain

RECRUITING

Related Links

• Offcial project website for the AI-Mind project

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for DNA isolation and plasma protein assessment will be collected from participants in the morning of the first visit, with participants non-fasting. Genetic analysis of the ε4 allele of APOE. The determination of phosphorylated form of tau.

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ira Haraldsen, PhD, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ira Haraldsen, PhD, MD

CONTACT

92011533; ira.haraldsen@icloud.com

Lina Plataniti, M.Sc.

CONTACT

45008425; linpla@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: December 16, 2021
• Study Start: March 1, 2021
• Primary Completion: September 30, 2025
• Study Completion: February 27, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

NO (1); ES (1); IT (2); FI (1)