Clinical trial NCT03448445: 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
Official title: An Observational Study to Evaluate AD Conversion Rate Differences Between High-risk MCI and Low Risk MCI in Real World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Keywords: High-risk
Low-risk
Alzheimer's disease
Observational study
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 201
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with mild cognitive impairment

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 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)

Primary outcomes:
measure: Rate of Alzheimer's Disease (AD) conversion differences between high-risk mild cognitive impairment (MCI) and low-risk MCI
timeFrame: Up to 36 months
Secondary outcomes:
measure: Mean change from Baseline in Seoul Neuropsychological Screening Battery-Dementia Version scores
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in Clinical Dementia Rating (CDR) Sum of Boxes scores
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in the CDR-Global Score
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in Geriatric Depression Scale scores
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in the volume of the whole brain according to Baseline demographics
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in other structural magnetic resonance imaging (MRI) measures according to Baseline demographics
timeFrame: Baseline, Month 12, Month 24
measure: Mean change from Baseline in the volume of the hippocampus according to Baseline demographics
timeFrame: Baseline, Month 12, Month 24
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Eisai Trial site_12
city: Busan
country: Korea, Republic of
facility: Eisai Trial site_11
city: Busan
country: Korea, Republic of
facility: Eisai Trial site_15
city: Changwon
country: Korea, Republic of
facility: Eisai Trial site_08
city: Daegu
country: Korea, Republic of
facility: Eisai Trial site_09
city: Daejeon
country: Korea, Republic of
facility: Eisai Trial site_05
city: Gachon
country: Korea, Republic of
facility: Eisai Trial site_03
city: Guri
country: Korea, Republic of
facility: Eisai Trial site_07
city: Gwangju
country: Korea, Republic of
facility: Eisai Trial site_10
city: Jeju
country: Korea, Republic of
facility: Eisai Trial site_16
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_01
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_02
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_04
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_06
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_13
city: Seoul
country: Korea, Republic of
facility: Eisai Trial site_14
Study officials:
References: