Home-based Cognitive Monitoring in MCI

Study Overview
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Brief Summary
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This study is an observational study to confirm usefulness of a home-based cognitive monitoring in non-demented patients with high-risk of dementia

Detailed Description
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We prospectively enroll subjects who were diagnosed as mild cognitive impairment based on neuropsychological tests battery, brain MRI, and routine blood labs including thyroid function tests, vitamine B12 & folate levels, and syphilis screening to rule out other secondary causes of dementia. We undergo peripheral blood-based amyloid beta levels and regular home-based cognitive monitoring (every 3 months) to investigate whether amyloid-positive MCIs progress rapidly using home-based cognitive monitoring during 6 months.

Official Title
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Usefulness of a Home-based Cognitive Monitoring in Non-demented Patients With High-risk of Dementia: a Prospective Observational Study

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Diagnostic Test: home-based cognitive monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent cognitive complaints aged 50 years old or older below -1.0 standard deviation in any domain of detailed neuropsychological tests battery named SNSB (Seoul neuropsychological screening battery) no ADL (activities of daily living) limitation subjects who agreed to participate Exclusion Criteria: dementia patients other structural brain disorders such as hydrocephalus, hemorrhage, or tumors other neurological disease such as Huntington's disease, Parkinson's disease, or epilepsy

Ages Eligible for Study
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Minimum Age: 50 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>MCI patients with amyloid beta positive (based on peripheral blood level) | Diagnostic Test: home-based cognitive monitoring<br>* a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0 30; higher score indicates better cognition)<br>|
| low risk MCI<br>MCI patients with amyloid beta negative (based on peripheral blood level) | Diagnostic Test: home-based cognitive monitoring<br>* a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0 30; higher score indicates better cognition)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| home-based cognitive monitoring score | a 3-5 minutes brief cognitive testing (range 0 30, higher score means better outcome) using telephone | 3 months (at baseline, 3 months from baseline, 6 months from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hippocampal atrophy grade | baseline brain MRI markers for hippocampal atrophy using Scheltens' visual rating scale (range 0 4, higher score means more hippocampal atrophy) | at baseline | 
| Number of lacunes | number of lacunes using manual counting on brain MRI (no limit) | at baseline | 
| Number of microbleeds | number of microbleeds using manual counting on brain MRI (no limit) | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild cognitive impairment, blood amyloid beta, home-based cognitive monitoring