A Study to Evaluate Alzheimer's Disease Conversion Rate Differences Between High-risk Mild Cognitive Impairment (MCI) and Low-risk MCI in a Real World Setting

Study Overview
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Brief Summary
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This study will be conducted to evaluate the rate of Alzheimer's disease conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI.

Official Title
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An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Other: Usual care setting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant over 55 years old and less than 90 years old Participant with subjective memory complaint by informant Clinical Dementia Rating (CDR) of 0.5; memory score box must be at least 0.5 General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the screening visit Essentially preserved activities of daily living Absence of dementia Participant with Seoul Neuropsychological Screening Battery-Dementia Version cut-off score between 134.25 and 188.25 Participants and caregivers who give written authorization to use their personal and health data Cognitive decline history within past 6 months from the baseline Exclusion Criteria: Diagnostic evidence of probable Alzheimer's disease consistent with National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association CDR-Global score (CDR-GS) >1 Participant who has taken memantine, acetylcholinesterase inhibitors, or nootropics prior to participating in this study Any significant neurologic disease: other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities Neuroimaging: participant with severe subcortical hyperintensities: D3-P3 Magnetic resonance imaging exclusions: presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body Participant who is pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk MCI<br>This cohort will include participants with high-risk mild cognitive impairment (MCI). | Other: Usual care setting<br>* usual care settings without any intervention<br>|
| Low-risk MCI<br>This cohort will include participants with low-risk MCI. | Other: Usual care setting<br>* usual care settings without any intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI | AD conversion differences will be assessed according to National Institute of Neurological and Communicative Diseases and Stroke-Alzheimer's Disease and Related Disorders Association Criteria for Probable AD. | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in the CDR-Global Score |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in Geriatric Depression Scale scores |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in the volume of the whole brain according to Baseline demographics |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in other structural magnetic resonance imaging (MRI) measures according to Baseline demographics |  | Baseline, Month 12, Month 24 | 
| Mean change from Baseline in the volume of the hippocampus according to Baseline demographics |  | Baseline, Month 12, Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High-risk, Low-risk, Alzheimer's disease, Observational study