Home-based Cognitive Monitoring in MCI

• Conditions: Mild Cognitive Impairment
• Interventions: Diagnostic Test: home-based cognitive monitoring

• Registration Number: NCT04350801
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-17
• Last Update Posted: 2020-04-20
• Primary Completion: 2020-11-01
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
high risk MCI	home-based cognitive monitoring	MCI patients with amyloid beta positive (based on peripheral blood level)
low risk MCI	home-based cognitive monitoring	MCI patients with amyloid beta negative (based on peripheral blood level)

Primary Outcome Measures

Name	Time	Method
home-based cognitive monitoring score	3 months (at baseline, 3 months from baseline, 6 months from baseline)	a 3-5 minutes brief cognitive testing (range 0\~30, higher score means better outcome) using telephone

Secondary Outcome Measures

Name	Time	Method
Hippocampal atrophy grade	at baseline	baseline brain MRI markers for hippocampal atrophy using Scheltens' visual rating scale (range 0\~4, higher score means more hippocampal atrophy)
Number of lacunes	at baseline	number of lacunes using manual counting on brain MRI (no limit)
Number of microbleeds	at baseline	number of microbleeds using manual counting on brain MRI (no limit)

Trial Locations

Locations (1)

Uijeongbu St. Mary's hospital; 🇰🇷 Uijeongbu, Korea, Republic of