Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138263
Recruitment Status : Not yet recruiting
First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Dong Young Lee, Seoul National University Hospital

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.

Condition or disease
Alzheimer Disease Mild Cognitive Impairment

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 640 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
Young normal controls
  • age : 20 ~ 54
  • without dementia, MCI, or other major neurological/psychiatric illness
Elderly normal controls
  • age : 55 ~ 90
  • without dementia, MCI, or other major neurological/psychiatric illness
MCI (Mild cognitive impairment)
  • age : 55 ~ 90
  • without major neurological/psychiatric illness
  • concern regarding a change in cognition, lower performance in any cognitive domain that is greater than would be expected for the subject's age and educational background and preservation of independence in functional abilities
AD (Alzheimer's diseases)
  • age: 55 ~ 90
  • National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD dementia(Alzheimer's diseases)



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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
Plasma, Serum, DNA, RNA, hair, and stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Dong young Lee, MD, PhD +82-2-2072-2205 selfpsy@snu.ac.kr

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
National Institute on Aging (NIA)
Investigators
Layout table for investigator information
Principal Investigator: Dong Young Lee, MD, PhD Department of Psychiatry, Seoul National University Hospital
Layout table for additonal information
Responsible Party: Dong Young Lee, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05138263    
Other Study ID Numbers: KBASE02
U01AG072177 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong Young Lee, Seoul National University Hospital:
Alzheimer Disease
Early diagnosis
Prediction
Biomarker
Neuroimaging
Network-based analysis
Multiomics
Systems biology
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders