Evaluation of association of vascular aging, chronic inflammation and degenerative brain disease
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008806
- Lead Sponsor
- Gachon University Gil Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
Dementia
-Alzheimer's Disease (AD): Participants with a Clinical Dementia Rating (CDR) of 0.5 or higher 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.
-Subcortical Vascular Dementia (SVaD): Participants with a CDR of 0.5 or higher, who meet the DSM-IV criteria for vascular dementia, and show moderate or higher white matter changes on MRI FLAIR imaging based on the modified Fazeka's scale.
Mild Cognitive Impairment (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.
Cognitively Normal
: 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.
-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 disorders such as claustrophobia or other major neurological conditions, such as traumatic brain injury, Parkinson's disease, -Huntington's disease, motor neuron diseases, multiple sclerosis, etc.
(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
-Individuals who have received radiation exposure exceeding 50msV (5rem) within the past year, including those who have undergone multiple scans such as PET, coronary angiography, abdomen-pelvic CT, etc.
-Individuals working in occupations with significant radiation exposure
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relationship between vascular elasticity, inflammatory markers, and Alzheimer's pathology : Generalized Linear Models (GLM) and Mediation Analysis
- Secondary Outcome Measures
Name Time Method Analysis of the impact of cognitive function and brain structural changes between groups: structural equation model, relative importance analysis