Alzheimer's DiseaseKBASENCT02137460
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- How many people
- 721 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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: 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 episodic memory domains 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 - 55
- Clinical Dementia Rating (CDR)=0
- Written informed consent
[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
1 site in 1 country.
About this study
This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people
Read the detailed description
The aim of the study is 1) to search new biomarkers and develop clinically applicable early diagnosis and prediction methods of Alzheimer's disease, and 2) to investigate how the proposed lifetime risk and protective factors for Alzheimer's disease contribute to pathological hallmarks of AD or other brain changes in living human through annual comprehensive clinical and neuropsychological evaluation and biannual brain imaging (MRI and MRA, Fluorodeoxyglucose(FDG)-PET, Pittsburgh compound B (PiB)-PET), AV--1451 PET, and body specimen (blood, gene, and hair) analysis.
- Note: AV-1451 PET will not be applied to whole subjects, but to 210 subjects (30 young CN, 60 old CN, 60 MCI, and 60 AD).
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Early diagnosis, Prediction, Biomarker, Imaging
- 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 ~ 55 * 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 episodic memory domains 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of brain amyloid deposition
Group difference in baseline brain amyloid deposition (on PIB PET) and the relationship between the amount of brain amyloid deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.
Measured: baseline
Secondary outcomes (6)
Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures
Group difference for clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical variables and correlations among these variables will be investigated.
Measured: baseline
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: baseline, 2yr, 4yr
Change of clinical, neuropsychological measures
The change of clinical, neuropsychological measurement and the relationship between these variables and other biomarkers will be assessed.
Measured: baseline, 1yr, 2yr,3yr, 4yr
Change of structural and functional neuroimaging measures
The change of structural and functional MRI measures and glucose metabolism of the brain the relationship between these variables and other clinical, neuropsychological, neuroimaging, biochemical, genetic biomarkers will be assessed.
Measured: baseline, 2yr, 4yr
Change of biochemical measures
The change of blood or hair-based biochemical measures and the relationship between these variables and other clinical, neuropsychological, neuroimaging, biochemical, genetic biomarkers will be assessed.
Measured: baseline, 2yr, 4yr
Chage of tau imaging measures
The change of tau PET imaging measures and the relationship between these measures and other clinical, neuropsychological, neuroimaging, biochemical, genetic biomarkers will be assessed.
Measured: 2yr, 4yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2022
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- 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
- NCT02137460
- Sponsor's protocol ID
- KBASE01
- Other IDs
- NRF-2013M3C7A1072998, NRF-2013M3C7A1069644, NRF-2014M3C7A1046042, NRF-2014M3C7A1046037
- Acronym
- KBASE
- Status last verified
- May 2024
- First submitted
- 8 May 2014
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. 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 Disease
- ClinicalTrials.gov ID
- NCT02137460
- Acronym / sponsor ID
- KBASE / KBASE01
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Early diagnosis, Prediction, Biomarker, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 13 May 2014 (estimated)
- 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.
This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people
Detailed description
The aim of the study is 1) to search new biomarkers and develop clinically applicable early diagnosis and prediction methods of Alzheimer's disease, and 2) to investigate how the proposed lifetime risk and protective factors for Alzheimer's disease contribute to pathological hallmarks of AD or other brain changes in living human through annual comprehensive clinical and neuropsychological evaluation and biannual brain imaging (MRI and MRA, Fluorodeoxyglucose(FDG)-PET, Pittsburgh compound B (PiB)-PET), AV--1451 PET, and body specimen (blood, gene, and hair) analysis.
- Note: AV-1451 PET will not be applied to whole subjects, but to 210 subjects (30 young CN, 60 old CN, 60 MCI, and 60 AD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young normal controls | – | –* age : 20 ~ 55 * 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 episodic memory domains 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 |
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
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
The amount of brain amyloid deposition
Time frame: baseline
Group difference in baseline brain amyloid deposition (on PIB PET) and the relationship between the amount of brain amyloid deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.
6 secondary outcomes
Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures
Time frame: baseline
Change of brain amyloid deposition
Time frame: baseline, 2yr, 4yr
Change of clinical, neuropsychological measures
Time frame: baseline, 1yr, 2yr,3yr, 4yr
Change of structural and functional neuroimaging measures
Time frame: baseline, 2yr, 4yr
Change of biochemical measures
Time frame: baseline, 2yr, 4yr
Chage of tau imaging measures
Time frame: 2yr, 4yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Seoul National University Hospital at 1 site 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?
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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The amount of brain amyloid deposition (time frame: baseline). 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 3 May 2024.