Alzheimer DiseaseKBASE2NCT05138263
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2 (KBASE2)
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- How many people
- 640 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jan 2022to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population
Who may be able to join
- [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
Show all 24Show fewer
- 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
Who cannot join
- [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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
SMG-SNU Boramae Medical Center
Seoul, Seoul
Seoul National University Hospital
Seoul, 03080
About this study
Official title: Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2
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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer Disease, Early diagnosis, Prediction, Biomarker, Neuroimaging, Network-based analysis, Multiomics, Systems biology
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of brain amyloid deposition
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.
Measured: baseline
Amount of brain tau deposition
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.
Measured: baseline
Secondary outcomes (4)
Change of brain amyloid deposition
The change of brain amyloid deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.
Measured: 2 years
Change of brain tau deposition
The change of brain tau deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.
Measured: 2 years
Change of CERAD total score
The change of CERAD total score and its relation to neuroimaging, genetic and biochemical variables will be assessed.
Measured: 2 years
Change of cortical thickness
The change of Alzheimer-signature region cortical thickness and its relation to neuroimaging, biochemical, genetic biomarkers will be assessed
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start1 Jan 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Dong Young Lee, Seoul National University Hospital
- Investigators
- Dong Young Lee, MD, PhD, Principal investigator, Department of Psychiatry, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138263
- Sponsor's protocol ID
- KBASE02
- Other IDs
- U01AG072177
- Acronym
- KBASE2
- Status last verified
- May 2026
- First submitted
- 23 Oct 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2
- ClinicalTrials.gov ID
- NCT05138263
- Acronym / sponsor ID
- KBASE2 / KBASE02
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer Disease, Early diagnosis, Prediction, Biomarker, Neuroimaging, Network-based analysis, Multiomics, Systems biology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population
Key inclusion criteria (24 listed)
- [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
Key exclusion criteria (8 listed)
- [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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Change of brain amyloid deposition
Time frame: 2 years
Change of brain tau deposition
Time frame: 2 years
Change of CERAD total score
Time frame: 2 years
Change of cortical thickness
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Young Lee, MD, PhD principal investigator
Department of Psychiatry, Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of brain amyloid deposition (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.