Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer’s disease2 (KBASE2)

Brief Title

Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2 (KBASE2)

Official Title

Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2

Brief Summary

      The KBASE2 is the second phase of the KBASE project, which consists of roll-over participants
      from the first phase of the KBASE as well as newly enrolled participants with varying degrees
      of cognitive functions (e.g. individuals with normal cognition, mild cognitive impairment, or
      AD dementia). In addition to the aims of the first phase of the KBASE, the KBASE2 will focus
      on new data collection and integrative analysis of the rich structural, functional, and
      molecular neuroimaging data in relation to whole genome sequencing and other -omics. Network
      analysis of disruption in brain connectivity in relation to clinical status and AD biomarker
      profiles also will be conducted.
    

Detailed Description

      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


Primary Outcome

Amount of brain amyloid deposition

Secondary Outcome

 Change of brain amyloid deposition

Condition

Alzheimer Disease


Study Arms / Comparison Groups

 Young normal controls
Description:  age : 20 ~ 54
without dementia, MCI, or other major neurological/psychiatric illness

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

640

Start Date

November 2021

Completion Date

June 2026

Primary Completion Date

June 2026

Eligibility Criteria

        Participants will be classified as either Alzheimer's disease(AD) group, mild cognitive
        impairment(MCI) group, elderly normal controls or young normal controls. Specific inclusion
        criteria for each group is described below.

        Inclusion Criteria:

        [Inclusion criteria: AD]

          -  Age : 55 - 90

          -  Clinical Dementia Rating (CDR)=0.5 or 1

          -  Diagnostic and Statistical Manual-IV(DSM-IV) criteria for dementia

          -  National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD
             dementia

          -  Study partner or caregiver to accompany patient to all scheduled visits

          -  Written informed consent

        [Inclusion criteria: MCI (amnestic)]

          -  Age : 55 - 90

          -  Clinical Dementia Rating (CDR)=0.5

          -  Concern regarding a change in cognition (obtained from the subject, from an informant
             who knows the subject, or from a skilled clinician observing the subject)

          -  Lower performance in any cognitive domain that is greater than would be expected for
             the subject's age and educational background

          -  Preservation of independence in functional abilities

          -  Study partner or caregiver to accompany subject to all scheduled visits

          -  Written informed consent

        [Inclusion criteria: Elderly normal controls]

          -  Age : 55 - 90

          -  Clinical Dementia Rating (CDR)=0

          -  Those with contactable Informant

          -  Written informed consent

        [Inclusion criteria: Young normal controls]

          -  Age : 20 - 54

          -  Clinical Dementia Rating (CDR)=0

          -  Written informed consent

        Exclusion Criteria:

        [Exclusion criteria: general]

          -  Past history or presence of major psychiatric illness (e.g. schizophrenia, bipolar
             disorder, alcohol/substance abuse or dependence, delirium)

          -  Significant neurologic or medical condition that can influence the mental state

          -  Contraindications for MRI scan (e.g. pacemaker, claustrophobia)

          -  Illiteracy

          -  Significant visual or hearing difficulty

          -  Taking investigational drug

          -  In pregnancy or breast-feeding
      

Gender

All

Ages

20 Years - 90 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dong Young Lee, MD, PhD, +82-2-2072-2205, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT05138263

Organization ID

KBASE02

Secondary IDs

U01AG072177

Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital

Collaborators

 National Institute on Aging (NIA)

Study Sponsor

Dong Young Lee, MD, PhD, Principal Investigator, Department of Psychiatry, Seoul National University Hospital


Verification Date

November 2021