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

NCT05138263 | Recruiting DMC

• 2 other identifiers: KBASE02U01AG072177
• Study Type: observational
• Target: 640
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Alzheimer Disease; Early diagnosis; Prediction; Biomarker; Neuroimaging; Network-based analysis; Multiomics; Systems biology

Outcome Measures

Primary Outcomes (2)

• Amount of brain amyloid deposition

  Group difference in baseline brain amyloid deposition on florbetaben PET and the relationship between the amount of brain amyloid deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.

  baseline

• Amount of brain tau deposition

  Group difference in baseline brain amyloid deposition on AV1451 PET and the relationship between the amount of brain tau deposition and clinical, neuropsychological, neuroimaging, genetic, biochemical measurement will be investigated.

  baseline

Secondary Outcomes (4)

• Change of brain amyloid deposition

  2 years

• Change of brain tau deposition

  2 years

• Change of CERAD total score

  2 years

• Change of cortical thickness

  2 years

Study Arms (4)

Young normal controls

* age : 20 \~ 54 * without dementia, MCI, or other major neurological/psychiatric illness

Elderly normal controls

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

MCI (Mild cognitive impairment)

* age : 55 \~ 90 * without major neurological/psychiatric illness * concern regarding a change in cognition, lower performance in any cognitive domain that is greater than would be expected for the subject's age and educational background and preservation of independence in functional abilities

AD (Alzheimer's diseases)

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

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Young and elderly normal controls: community-based population AD and MCI: clinic or community-based population

You may qualify if:

• 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 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
• Age : 55 - 90
• Clinical Dementia Rating (CDR)=0

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, DNA, RNA, hair, and stool

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dong Young Lee, MD, PhD

  Department of Psychiatry, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong young Lee, MD, PhD

CONTACT

+82-2-2072-2205; selfpsy@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 30, 2021
• Study Start: January 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

KR (2)