Digital tools for assessing brain connectivity and dementia risk in people with mild cognitive impairment
Intelligent Digital Tools for Screening of Brain Connectivity and Dementia Risk Estimation in People Affected by Mild Cognitive Impairment
This study is testing new digital tools that use brain scans to see if they can help identify the risk of dementia in people with mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 60 Years to 75 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 5 sites (Helsinki and 4 other locations) |
| Trial ID | NCT05159661 on ClinicalTrials.gov |
What this trial studies
This study aims to validate artificial intelligence-based tools designed to screen brain connectivity and estimate dementia risk in individuals diagnosed with mild cognitive impairment (MCI). Conducted across five clinical centers in Europe, the AI-Mind project will utilize EEG technology and advanced machine learning techniques to identify dysfunctional brain networks and assess the risk of developing dementia. The study will generate personalized reports for patients, potentially facilitating early intervention and improved management of cognitive decline.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 60 to 75 years with a diagnosis of mild cognitive impairment.
Not a fit: Patients with confirmed dementia or severe cognitive impairments due to other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for patients at risk of developing dementia, potentially extending their 'dementia-free' period.
How similar studies have performed: Other studies utilizing AI and EEG technology for cognitive assessment have shown promise, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female aged between 60 and 75 years * MCI diagnosis with a MMSE \>= 25 * or MCI diagnosis with MoCa \>= 17 Exclusion Criteria: * 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.
Where this trial is running
Helsinki and 4 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Università Cattolica del Sacro Cuore Campus di Roma — Roma, Italy (Recruiting)
- Scientific Institute for Research, Hospitalization and Healthcare — Roma, Italy (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Universidad Complutense de Madrid — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Ira Haraldsen, PhD, MD — Oslo University Hospital
- Study coordinator: Ira Haraldsen, PhD, MD
- Email: ira.haraldsen@icloud.com
- Phone: 92011533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.