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

Completed

• Conditions: Mild Cognitive Impairment; Alzheimer's Disease

• Registration Number: NCT02137460
• Lead Sponsor: 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

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 Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-10
• Study First Posted: 2014-05-13
• Primary Completion: 2022-12
• Study Completion: 2023-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 721

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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 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.
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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of