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

Seoul National University

Status: Completed

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Study type: Observational

Funder types: Other

Identifiers

NCT02137460

NRF-2014M3C7A1046042 (Other Grant/Funding Number)

NRF-2014M3C7A1046037 (Other Grant/Funding Number)

KBASE01

NRF-2013M3C7A1069644 (Other Grant/Funding Number)

NRF-2013M3C7A1072998 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment: 721 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

721 participants in 4 patient groups

Young normal controls

Description:

* age : 20 \~ 55 * without dementia, MCI, or other major neurological/psychiatric illness

Elderly normal controls

Description:

* age : 55 \~ 90 * without dementia, MCI, or other major neurological/psychiatric illness

MCI (Mild cognitive impairment)

Description:

* 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)

Description:

* age: 55 \~ 90 * National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD dementia