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

Mild Cognitive Impairment Clinical Trial

— KBASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137460
• Other study ID #: KBASE01
• Secondary ID: NRF-2013M3C7A107
• Status: Completed
• Start date: May 2014
• Est. completion date: January 2023

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 721
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Science and ICT, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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