No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Study type
Observational
Participants needed
4,000 (estimated)
Sponsor
Ewha Womans University Mokdong Hospital · Other
Who this trial is looking for
This trial is looking for people with mild cognitive issues or Alzheimer's disease to help test new treatments and improve diagnosis methods. Participants will provide information about their health and may take new medications designed for Alzheimer's.
Are You a Good Fit for This Trial?
You may be able to join if
I am 19 years of age or older.
I am being evaluated for new Alzheimer's medications approved after 2021.
I have had an amyloid PET scan or cerebrospinal fluid testing for Alzheimer's.
I have been diagnosed with Alzheimer's disease or mild cognitive impairment.
I am still able to live independently.
I can walk, even with mobility aids.
I am able to give written consent to participate.
You may not be able to join if
I have severe psychiatric disorders.
I have a history of substance abuse requiring treatment in the last five years.
I currently have untreated cancer.
I have severe health conditions that are unstable.
I have visual or auditory problems that affect cognitive testing.
I have metallic substances in my body preventing an MRI.
I am currently in another drug trial.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 t…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. Participants must be 19 years of age or older at the time of informed consent.
2. Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultati…
Inclusion Criteria:
1. Participants must be 19 years of age or older at the time of informed consent.
2. Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultation with their physician after 2021, or patients who have already started treatment with newly approved Alzheimer's disease medications after 2021.
3. Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.
4. Clinical diagnosis of Alzheimer's disease, defined as follows:
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1. \[Alzheimer's Disease Dementia (ADD)\] - 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).
* Must exhibit cognitive decline that impairs independent daily living.
2. \[Mild Cognitive Impairment (MCI)\]
\- Must meet NIA-AA diagnostic criteria for MCI.
\- The subject or informant must report cognitive decline.
\- Performance on delayed recall of verbal memory must be more than -1.0 SD below the age- and education-adjusted normative mean, or scores on any one or more tests of executive function, language, visuospatial abilities, or attention must be more than -1.5 SD below the age- and education-adjusted normative mean.
\- Clinical Dementia Rating scale (CDR) of 0.5.
\- Maintenance of independent daily living ability.
\- Not categorized as dementia.
3. \[Cognitively Unimpaired (CU)\]
\- Delayed recall of verbal memory must be at or above -1.0 SD versus the age- and education-adjusted normative mean, and all executive function, language, visuospatial abilities, and attention tests must be at or above -1.5 SD versus the age- and education-adjusted normative mean.
\- Maintenance of independent daily living ability.
* If the subject reports cognitive decline, they will be classified as having Subjective Cognitive Decline (SCD).
5\. Patients must be ambulatory (use of mobility aids is acceptable). 6. The subject must provide written informed consent to participate in the study. In the case of dementia patients, additional written consent from a guardian is required.
Exclusion Criteria:
1. Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.
2. History of substance abuse or alcohol dependence that required treatment within the past five years.
3. A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded.
4. Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).
5. Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.
6. Inability to perform MRI due to the presence of metallic substances in the body.
7. Currently participating in another drug clinical trial.
8. Currently pregnant or breastfeeding.
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