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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02137460

Acronym

KBASE

Enrollment

721

Registered

2014-05-13

Start date

2014-05-31

Completion date

2023-01-31

Last updated

2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Mild Cognitive Impairment

Keywords

Alzheimer's disease, Early diagnosis, Prediction, Biomarker, Imaging

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
The amount of brain amyloid deposition	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

Measure	Time frame	Description
Change of brain amyloid deposition	baseline, 2yr, 4yr	The change of brain amyloid deposition and its relation to the clinical, neuropsychological, neuroimaging, genetic and biochemical variables will be assessed.
Change of clinical, neuropsychological measures	baseline, 1yr, 2yr,3yr, 4yr	The change of clinical, neuropsychological measurement and the relationship between these variables and other biomarkers will be assessed.
Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures	baseline	Group difference for clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical variables and correlations among these variables will be investigated.
Change of biochemical measures	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.
Chage of tau imaging measures	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.
Change of structural and functional neuroimaging measures	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.

Countries

South Korea

Outcome results