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Completed

NCT Number: NCT02137460

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

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Science and ICT, Republic of Korea

Registry information

Acronym: KBASE

Important dates

Study start
2014
Primary completion
2022
Study completion
2023
First posted
May 13, 2014
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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