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Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease (KBASE)

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ClinicalTrials.gov Identifier: NCT02137460
Recruitment Status : Active, not recruiting
First Posted : May 13, 2014
Last Update Posted : October 5, 2017
Sponsor:
Collaborators:
Ministry of Science and ICT, Republic of Korea
Seoul National University
Information provided by (Responsible Party):
Dong Young Lee, Seoul National University Hospital

Brief Summary:
This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people

Condition or disease
Alzheimer's Disease Mild Cognitive Impairment

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).


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Study Type : Observational
Estimated Enrollment : 920 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease
Study Start Date : May 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures [ Time Frame: baseline ]
    Group difference for clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical variables and correlations among these variables will be investigated.

  2. Change of brain amyloid deposition [ Time Frame: baseline, 2yr, 4yr ]
    The change of brain amyloid deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.

  3. Change of clinical, neuropsychological measures [ Time Frame: baseline, 1yr, 2yr,3yr, 4yr ]
    The change of clinical, neuropsychological measurement and the relationship between these variables and other biomarkers will be assessed.

  4. Change of structural and functional neuroimaging measures [ Time Frame: baseline, 2yr, 4yr ]
    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.

  5. Change of biochemical measures [ Time Frame: baseline, 2yr, 4yr ]
    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.

  6. Chage of tau imaging measures [ Time Frame: 2yr, 4yr ]
    The change of tau PET imaging measures and the relationship between these measures and other clinical, neuropsychological, 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

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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: 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

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): NCT02137460


Locations
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Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong Young Lee
Ministry of Science and ICT, Republic of Korea
Seoul National University
Investigators
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Principal Investigator: Dong Young Lee, MD, PhD Department of Psychiatry, Seoul National University College of Medicine

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Responsible Party: Dong Young Lee, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02137460     History of Changes
Other Study ID Numbers: KBASE01
NRF-2013M3C7A1072998 ( Other Grant/Funding Number: NRF-2013M3C7A1072998 )
NRF-2013M3C7A1069644 ( Other Grant/Funding Number: NRF-2013M3C7A1069644 )
NRF-2014M3C7A1046042 ( Other Grant/Funding Number: NRF-2014M3C7A1046042 )
NRF-2014M3C7A1046037 ( Other Grant/Funding Number: NRF-2014M3C7A1046037 )
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Keywords provided by Dong Young Lee, Seoul National University Hospital:
Alzheimer's disease
Early diagnosis
Prediction
Biomarker
Imaging

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cognitive Dysfunction
Dementia
Tauopathies