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

Last updated: May 2, 2024
Sponsor: Seoul National University Hospital
Overall Status: Completed

Phase

N/A

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT02137460
KBASE01
NRF-2014M3C7A1046042
NRF-2013M3C7A1072998
NRF-2014M3C7A1046037
NRF-2013M3C7A1069644
  • Ages 20-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Participants will be classified as either Alzheimer's disease(AD) group, mild cognitiveimpairment(MCI) group, elderly normal controls or young normal controls. Specific inclusioncriteria 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 ADdementia
  • 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 informantwho knows the subject, or from a skilled clinician observing the subject)
  • Lower performance in episodic memory domains that is greater than would be expectedfor 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

[Exclusion criteria: general]

  • Past history or presence of major psychiatric illness (e.g. schizophrenia, bipolardisorder, 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

Study Design

Total Participants: 721
Study Start date:
May 01, 2014
Estimated Completion Date:
January 31, 2023

Study 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).

Connect with a study center

  • Seoul National University Hospital

    Seoul, 110-744
    Korea, Republic of

    Site Not Available

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