Mild Cognitive Impairment
Conditions
Keywords
High-risk, Low-risk, Alzheimer's disease, Observational study
Brief summary
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.
Interventions
OTHERUsual care setting
usual care settings without any intervention
Sponsors
Eisai Korea Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI | Up to 36 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 Seoul Neuropsychological Screening Battery-Dementia Version scores | 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 |
| Mean change from Baseline in the volume of the whole brain according to Baseline demographics | Baseline, Month 12, Month 24 |
Countries
South Korea
Outcome results
None listed