NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2 (KBASE2)

Active Not RecruitingN/A

Sponsor: Seoul National University Hospital

Conditions: Alzheimer Disease, Mild Cognitive Impairment

Countries: South Korea

The KBASE2 is the second phase of the KBASE project, which consists of roll-over participants from the first phase of the KBASE as well as newly enrolled participants with varying degrees of cognitive functions (e.g. individuals with normal cognition, mild cognitive impairment, or AD dementia). In addition to the aims of the first phase of the KBASE, the KBASE2 will focus on new data collection and integrative analysis of the rich structural, functional, and molecular neuroimaging data in relation to whole genome sequencing and other -omics. Network analysis of disruption in brain connectivity in relation to clinical status and AD biomarker profiles also will be conducted.

Eligibility overview

Sex: ALL

Age: 20 Years to 90 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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:

\[Inclusion criteria: AD\]

* 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 any cognitive domain 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 - 54
* Clinical Dementia Rating (CDR)=0
* Written informed consent

Exclusion Criteria:

\[Exclusion criteria: general\]

* 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

Locations (2)

Seoul, Seoul, South Korea
Seoul, South Korea