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Advancement of AI software for neurofluid activity-based dementia image diagnosis and prognostic scoring

Advancement of AI software for neurofluid activity-based dementia image diagnosis and prognostic scoring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010439
Enrollment
140
Registered
2025-04-21
Start date
2025-03-21
Completion date
Unknown
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Gachon University Gil Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Cognitively Normal (CN) - Participants with a Clinical Dementia Rating (CDR) of 0 and without objective evidence of cognitive decline (less than -1.5 standard deviations) based on comprehensive neuropsychological test. 2. Mild Cognitive Impairment (MCI)/mild Alzheimer's dementia (AD) - MCI: Participants with a Clinical Dementia Rating (CDR) of 0.5, but without dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text-revision (DSM-IV-TR) criteria. - AD: Participants with a Clinical Dementia Rating (CDR) of 0.5 or 1 and who meet the DSM-IV-TR criteria for dementia and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable or possible AD.

Exclusion criteria

Exclusion criteria: - Pregnant women (Excluded if even slightly suspected of being pregnant based on surveys or menstrual cycle information) - Women currently breastfeeding - Patients with severely compromised overall health to the extent that conducting tests is difficult - Individuals with seizure such as claustrophobia or other epilepsy - Patients with other major neurological conditions such as traumatic brain injury, Parkinson's disease, Huntington's disease, motor neuron diseases, multiple sclerosis, etc. - Patients who have had a stroke in the cerebrum, brainstem, or cerebellum (Note: Exclusion is only considered if the study director (physician) deems it would significantly affect the study.) - Patients diagnosed with psychiatric disorders such as schizophrenia - Patients with brain tumors, hydrocephalus, encephalitis, or metabolic encephalopathy - Women who are currently pregnant or using intrauterine contraceptive devices - Individuals deemed inappropriate for the study by the clinical researcher - Persons with cardiac pacemakers or metallic implants within the body (Except for titanium and titanium alloy implants, or if a specialist confirms that there are no issues with a 3T MRI scan) - Patients with metallic objects in the head and neck that can cause image distortion during MRI scans

Design outcomes

Primary

MeasureTime frame
Brain MRI-Based Evaluation of Neurofluid Activity

Secondary

MeasureTime frame
Measurement of cerebral blood flow dynamics, Assessment of microvascular elasticity index (MRIR);Plasma biomarkers related to dementia risk factors and blood-brain barrier integrity;Standardized evaluation of memory, attention, language ability, visuospatial functions, and executive function, based on normative data;Physical activity & functional performance and muscle strength assessments

Countries

Korea, Republic of

Contacts

Public ContactYoung Noh

Gachon University Gil Medical Center

dementia9043@gmail.com+82-32-460-9043

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026