An observational study in Mild Cognitive Impairment, Dementia and Subjective Cognitive Decline (SCD), sponsored by Ewha Womans University Mokdong Hospital. Recruiting at 3 sites in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-21.
Sponsored by Ewha Womans University Mokdong Hospital · Observational
The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to evaluate the impact of these new therapies and diagnostic techniques in clinical practice.
In 2024, it is estimated that there will be over 1 million individuals aged 65 and older with dementia in South Korea, with national dementia care costs exceeding approximately 17 trillion KRW (0.9% of GDP). South Korea is experiencing rapid population aging, leading to a projected significant increase in both the number of patients and the associated socio-economic costs. Alzheimer's disease (AD) is the most common cause of dementia and cognitive impairment in the elderly, characterized by the abnormal accumulation of amyloid beta (Aβ) and tau proteins in the brain. Research has shown that beta-amyloid protein begins to accumulate in the brain over 20 years before the onset of memory impairment symptoms. Consequently, Alzheimer's disease progresses through a prolonged asymptomatic stage of normal cognitive function (cognitively unimpaired, CU) to subjective cognitive decline, mild cognitive impairment, and dementia.
In May 2024, the Korean Ministry of Food and Drug Safety approved lecanemab for the treatment of Alzheimer's disease. Recent advancements have been made in the development of new treatments and diagnostic methods for Alzheimer's disease, with some already approved for use in South Korea or anticipated to receive approval soon. These developments are expected to significantly impact the management of dementia and cognitive impairment patients in the near future. Among the new treatments, monoclonal antibody injections targeting the core pathological mechanism of Alzheimer's disease, which is the removal of beta-amyloid protein (e.g., lecanemab, donanemab), currently lack long-term efficacy data, providing only 1-2 years of investigatory data in clinical trials. Such medications may have side effects, including amyloid-related imaging abnormalities (ARIA) such as brain edema or microbleeding and infusion-related adverse reactions. For the advancement of precise treatments for Alzheimer's disease, it is essential to monitor long-term effects and side effects of these drugs in clinical practice to collect and analyze more extensive clinical data to establish additional clinical evidence.
Moreover, the phase 3 clinical trial data for lecanemab suggests that the drug's effectiveness and side effects may vary by ethnicity. Recently, a diagnostic technique that measures Elecsys beta-amyloid 42 (Aβ42) and Elecsys Phospho-Tau181 (ptau181) in cerebrospinal fluid (CSF) has received approval from the Korean Ministry of Food and Drug Safety for the diagnosis of Alzheimer's disease. Additionally, there is a strong potential for new diagnostic methods that measure proteins such as ptau217, ptau181, and Aβ42 in blood to be commercialized in clinical practice. Future advancements through real-world data collection on these new diagnostic methods will be necessary.
The Alzheimer's Association (AA) and researchers in the United States have initiated a registry study named the Alzheimer's Network for Treatment and Diagnostics (ALZ-NET) to collect real-world data on new treatments and diagnostic methods for Alzheimer's disease. Longitudinal studies to investigate the long-term effectiveness and safety of new treatments and diagnostic methods in Alzheimer's patients are also being established in countries such as Japan, Australia, the Netherlands, and Europe. In response to these changes in Alzheimer's disease management, the researchers aim to contribute to the precision of Alzheimer's treatment and the enhancement of new diagnostic methods by collecting real-world data from Korean Alzheimer's patients regarding the long-term effectiveness and safety of new therapies.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Ewha Womans University Mokdong Hospital is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Approximately 40 medical institutions nationwide are expected to participate in the study over a period of 10 years, with about 4,000 participants in total. Our institution anticipates the participation of approximately 100 subjects. Participants in this study are adults with Alzheimer's disease dementia, mild cognitive impairment, or normal cognitive function (including subjective cognitive decline) who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, have made the decision to initiate treatment with these medications, or have already begun treatment with these newly approved Alzheimer's disease medications.
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[Alzheimer's Disease Dementia (ADD)] - Must meet the criteria for probable Alzheimer's dementia as defined by the National Institute on Aging and the Alzheimer's Association working groups (NIA-AA).
[Mild Cognitive Impairment (MCI)]
[Cognitively Unimpaired (CU)]
If the subject reports cognitive decline, they will be classified as having Subjective Cognitive Decline (SCD).
Exclusion Criteria:
Collection of real-world data from enrolled patients being evaluated for or receiving novel Korea MFDS-approved Alzheimer's disease treatments and diagnostics
Change from baseline in the Korean Mini-Mental State Examination-2 (K-MMSE-2) total score
This test consists of orientation to time and place, three-word recall, subtracting 7 from 100 in succession, overlapping pentagon drawing, command execution, reading, writing, repeating, and naming. The score ranges from 0 to 30.
Time frame: Up to 10 years
Change from baseline in the Korean version of Montreal Cognitive Assessment (K-MOCA) total score
This assessment evaluates memory, language, executive function, visuospatial construction, reasoning, and attention, with a scoring range of 0-30 points where higher scores indicate better cognitive function.
Time frame: Up to 10 years
Change from baseline in the Clinical Dementia Rating scale (CDR) total score
Scores include a Global CDR (0-3 points) and a CDR-Sum of Boxes (SB) which sums the scores of the six domains (0-18 points). Higher scores indicate worse cognitive function.
Time frame: Up to 10 years
Change from baseline in the Functional Assessment Questionnaire (FAQ) total score
The informant evaluates the subject, with a score range of 0-30, where higher scores indicate a decline in daily functioning. A score of 9 or more suggests significant deterioration in daily functioning.
Time frame: Up to 10 years
Change from baseline in the Korean version of the Alzheimer disease 8 (K-AD8) total score
The score ranges from 0 to 8, where higher scores indicate more severe cognitive impairment.
Time frame: Up to 10 years
Brain Magnetic Resonance Imaging (MRI)
Data will be collected to diagnose cognitive impairment and to assess for emergence of amyloid related imaging abnormalities.
Time frame: Up to 10 years
Alzheimer's disease (AD) biomarkers
Data from past amyloid Positron Emission Tomography (PET) scans will be collected for the diagnosis of AD. Results for cerebrospinal fluid assays of Elecsys Aβ42, Elecsys ptau181, and ptau181/Aβ42 will also be collected. A ptau181/Aβ42 ratio greater than 0.023 indicates a suggestion of AD.
Time frame: Up to 10 years
Plan to share: Yes — Data will be shared with Eisai and gAAIN.
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Ewha Womans University Mokdong Hospital