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Search / Trial NCT05159661

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

Launched by OSLO UNIVERSITY HOSPITAL · Dec 10, 2021

Trial Information

Current as of October 25, 2025

Recruiting

Keywords

Mci Ai Eeg Alzheimer Dementia Functional Brain Connectivity Deep Learning Machine Learning

ClinConnect Summary

This clinical trial, called the AI-Mind project, is studying how to better identify and assess the risk of dementia in people who have mild cognitive impairment (MCI). The goal is to develop two digital tools powered by artificial intelligence that can help spot problems in brain connectivity and provide personalized reports on dementia risk. This approach aims to improve early diagnosis and intervention, potentially allowing people to stay 'dementia-free' for longer.

To be eligible for this trial, participants should be between 60 and 75 years old and have a diagnosis of mild cognitive impairment, with certain scores on specific cognitive tests (MMSE or MoCA). Individuals with confirmed dementia, severe mental disorders, or significant medical conditions affecting cognition are not eligible. Participants can expect to undergo brain connectivity assessments and receive personalized reports that may lead to new treatment options. This trial is currently recruiting participants, and it seeks to make a significant impact on how we approach dementia care in the future.

Gender

ALL

Eligibility 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.

About Oslo University Hospital

Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.

Locations

Madrid, Spain

Oslo, Norway

Madrid, Mad, Spain

Helsinki, Finland

Roma, Italy

Roma, Italy

Patients applied

0 patients applied

Trial Officials

Ira Haraldsen, PhD, MD

Principal Investigator

Oslo University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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