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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease

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 Type: Observational
• Enrollment (Anticipated): 920

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Elderly normal controls; age : 55 ~ 90; without dementia, MCI, or other major neurological/psychiatric illness
Young normal controls; age : 20 ~ 55; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	2yr, 4yr

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Science and ICT, Republic of Korea
• Investigators: Principal Investigator: Dong Young Lee, MD, PhD, Department of Psychiatry, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 10, 2014
• First Posted (Estimate): May 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Imaging; Alzheimer's disease; Prediction; Early diagnosis
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• 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)