NCT05159661 · RECRUITING

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

This trial is testing AI-powered digital tools that analyze brain connectivity patterns in people who already have mild cognitive impairment, to estimate their personal risk of progressing to dementia. No drugs or treatments are involved — the tools use brain scans and data to generate individualized risk reports. The phase is unspecified, so it reads more like a diagnostic validation study than a traditional drug trial.

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're excluded 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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2024-04-02

View full record on ClinicalTrials.gov

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