Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2 (KBASE2) (KBASE2)
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|ClinicalTrials.gov Identifier: NCT05138263|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2021
Last Update Posted : November 30, 2021
|Condition or disease|
|Alzheimer Disease Mild Cognitive Impairment|
The Korean Brain Aging Study for the Early Diagnosis and Prediction of AD (KBASE) is a comprehensive prospective cohort study launched at Seoul National University (SNU) in 2014 using similar methods to the North American AD Neuroimaging Initiative (ADNI). KBASE includes well-characterized participants with normal cognition (CN), mild cognitive impairment (MCI) and AD dementia. Clinical/cognitive and lifestyle data, multimodal neuroimaging (structural MRI, MR angiography, diffusion tensor imaging, and resting-state fMRI, as well as amyloid, tau and FDG-PET, and bio-specimens were longitudinally collected during the past five years.
The KBASE2, the second phase of the KBASE project, will focus on new data collection and integrative analysis of the rich structural, functional, and molecular neuroimaging data in relation to WGS and other -omics. Network analysis of disruption in brain connectivity in relation to clinical status and AD biomarker profiles in KBASE will be related back to the NIA AD Sequencing Project (ADSP) multi-ethnic dataset (N>20,000) results. Amyloid, tau, neurodegeneration, and cerebrovascular integrity (A/T/N/V) neuroimaging biomarkers will be investigated cross-sectionally and longitudinally. Findings will be contrasted with and validated in independent cohorts, including ADNI and the Indiana Memory and Aging Study (IMAS), which both have similar genetic and deep longitudinal endophenotype data. The overarching premise is that 1) development of precision medicine for ADRD requires systematic multi-modal biomarker collection in diverse cohorts during early at-risk stages of disease to identify diagnostic, prognostic and therapeutic targets, and 2) sophisticated analytic strategies are required to address the complexity of multimodal data, heterogeneity, and diverse participant cohorts. Integrative longitudinal analysis of genetic and -omics networks with structural and functional brain networks in this Asian cohort will yield new targets related to A/T/N/V pathology and other pathways
In KBASE2 projects, the KBASE team at Seoul National University (SNU) and AD research team at Indiana University (ADNI Genetics Core, Indiana ADRC, IU Network Science Institute) will closely collaborate with the ADSP and its multi-institutional working groups, and the Universities of Pennsylvania and Southern California. Whole genome sequences (WGS) will be ADSP-harmonized by the NIA Genomic Center for AD (GCAD) and shared via NIAGADS (both UPenn). The Laboratory of Neuroimaging (LONI; USC) will support imaging and related data sharing.
|Study Type :||Observational|
|Estimated Enrollment :||640 participants|
|Official Title:||Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2|
|Estimated Study Start Date :||November 2021|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||June 2026|
Young normal controls
Elderly normal controls
MCI (Mild cognitive impairment)
AD (Alzheimer's diseases)
- Amount of brain amyloid deposition [ Time Frame: baseline ]Group difference in baseline brain amyloid deposition on florbetaben PET and the relationship between the amount of brain amyloid deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.
- Amount of brain tau deposition [ Time Frame: baseline ]Group difference in baseline brain amyloid deposition on AV1451 PET and the relationship between the amount of brain tau deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.
- Change of brain amyloid deposition [ Time Frame: 2 years ]The change of brain amyloid deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.
- Change of brain tau deposition [ Time Frame: 2 years ]The change of brain tau deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.
- Change of CERAD total score [ Time Frame: 2 years ]The change of CERAD total score and its relation to neuroimaging, genetic and biochemical variables will be assessed.
- Change of cortical thickness [ Time Frame: 2 years ]The change of Alzheimer-signature region cortical thickness and its relation to neuroimaging, biochemical, genetic biomarkers will be assessed
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05138263
|Contact: Dong young Lee, MD, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Dong Young Lee, MD, PhD||Department of Psychiatry, Seoul National University Hospital|