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

NCT ID: NCT02137460

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 721 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2023-01-31

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).

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Young normal controls

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

No interventions assigned to this group

Elderly normal controls

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

No interventions assigned to this group

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

No interventions assigned to this group

AD (Alzheimer's diseases)

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Age : 55 - 90
• Clinical Dementia Rating (CDR)=0
• Those with contactable Informant
• Written informed consent

• Age : 20 - 55
• Clinical Dementia Rating (CDR)=0
• Written informed consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Young Lee

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Young Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

NRF-2013M3C7A1072998

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NRF-2013M3C7A1069644

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NRF-2014M3C7A1046042

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NRF-2014M3C7A1046037

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KBASE01

Identifier Type: -

Identifier Source: org_study_id