Status:
COMPLETED
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
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-89 years
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT03448445
Start Date
June 22 2018
End Date
August 10 2021
Last Update
October 6 2021
Active Locations (16)
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1
Eisai Trial site_12
Anyang, South Korea
2
Eisai Trial site_11
Busan, South Korea
3
Eisai Trial site_15
Busan, South Korea
4
Eisai Trial site_08
Changwon, South Korea