Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's disease2
This study is trying to find out how to spot Alzheimer's disease early by looking at brain scans and genetic information from people with different levels of memory and thinking skills.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 640 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05138263 on ClinicalTrials.gov |
What this trial studies
The KBASE2 project is a continuation of the KBASE initiative, focusing on the early diagnosis and prediction of Alzheimer's disease (AD) through comprehensive data collection and analysis. It involves participants with varying cognitive functions, including those with normal cognition, mild cognitive impairment, and AD dementia. The study utilizes advanced neuroimaging techniques and whole genome sequencing to investigate brain connectivity and biomarker profiles. The findings will be compared with data from other large cohorts to enhance the understanding of AD.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 55-90 with either Alzheimer's disease, mild cognitive impairment, or normal cognitive function.
Not a fit: Patients with severe cognitive impairment or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early diagnosis and personalized treatment strategies for Alzheimer's disease.
How similar studies have performed: Previous studies, such as the ADNI, have shown success in similar approaches, indicating the potential for meaningful advancements in understanding Alzheimer's disease.
Eligibility criteria
Show full inclusion / 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: \[Inclusion criteria: AD\] * 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
Where this trial is running
Seoul and 1 other locations
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- SMG-SNU Boramae Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong Young Lee, MD, PhD — Department of Psychiatry, Seoul National University Hospital
- Study coordinator: Dong young Lee, MD, PhD
- Email: selfpsy@snu.ac.kr
- Phone: +82-2-2072-2205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.