Clinical trial NCT02137460: Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease
Official title: Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Alzheimer's disease
Early diagnosis
Prediction
Biomarker
Imaging
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2014-05-13
Enrollment: 721
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population

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).

Eligibility 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

Primary outcomes:
measure: The amount of brain amyloid deposition
timeFrame: baseline
Secondary outcomes:
measure: Group difference for each clinical, neuropsychological, structural and functional neuroimaging, tau imaging, genetic, biochemical measures
timeFrame: baseline
measure: Change of brain amyloid deposition
timeFrame: baseline, 2yr, 4yr
measure: Change of clinical, neuropsychological measures
timeFrame: baseline, 1yr, 2yr,3yr, 4yr
measure: Change of structural and functional neuroimaging measures
timeFrame: baseline, 2yr, 4yr
measure: Change of biochemical measures
timeFrame: baseline, 2yr, 4yr
measure: Chage of tau imaging measures
timeFrame: 2yr, 4yr
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Department of Psychiatry, Seoul National University Hospital
name: Dong Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: