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Korea Alzheimer's Disease Neuroimaging Initiative

Korean Alzheimers' Disease Neuroimaing Intitiative · 2012
ClinicalTrials.gov · Datasets · License: Public Domain · 2012
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alzheimer-s-diseasebiomarkersdementiaearly-detectionmild-cognitive-impairmentneuroimaging
PRIMARY OBJECTIVES -Establish a registry for Alzheimer's disease (AD) and subcortical ischemic vascular dementia (SIVD) STUDY DESIGN -This is a non-randomized, natural history, observational, registry study. SAMPLE SIZE AND RECRUITMENT \- Five hundred subjects will be enrolled at each clinical site (50 NC, 200 with MCI, 50 with AD, 100 with vMCI, and 100 with SIVD) SUMMARY OF KEY ELIGIBILITY CRITERIA * Newly enrolled subjects will be between 50-80 (inclusive) years of age. * 1\) Cognitively Normal Subjects * 2\) MCI subjects * 3\) AD subjects * 4\) vMCI or SIVD PROCEDURES * Recruited subjects will have clinical/cognitive assessments, biomarker and genetic sample collection, and imaging. * Subjects will be followed up for 36 months from the baseline visit. All assessments are to be performed every year from baseline(0, 12, 24, 36 months), except; 1) FDG-PET and amyloid-PET will be performed every two years, i.e., on baseline and at 24 month visit. 2) CSF collection will also be performed on baseline and at 24 months visit. 3) Clinical/cognitive assessment and MRI evaluation will additionally be done at 6 months from baseline to determine short term change. OUTCOME MEASURES * Group differences for each clinical, cognitive, biochemical, and imaging measurement. * Rate of conversion or change of disease severity will be evaluated among all groups * Correlations among biomarkers and biomarker changes
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