Home-based Cognitive Monitoring in MCI

NCT ID: NCT04350801

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-30

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.

Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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high risk MCI

MCI patients with amyloid beta positive (based on peripheral blood level)

home-based cognitive monitoring

Intervention Type DIAGNOSTIC_TEST

a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0\~30; higher score indicates better cognition)

low risk MCI

MCI patients with amyloid beta negative (based on peripheral blood level)

home-based cognitive monitoring

Intervention Type DIAGNOSTIC_TEST

a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0\~30; higher score indicates better cognition)

Interventions

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home-based cognitive monitoring

a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0\~30; higher score indicates better cognition)

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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YunJeong Hong, MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YunJeong Hong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uijeongbu St. Mary's Hospital

Locations

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Uijeongbu St. Mary's hospital

Uijeongbu-si, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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YunJeong Hong, MD,PhD

Role: CONTACT

820318203933

Facility Contacts

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YunJeong Hong, MD, PhD

Role: primary

820318203933

Other Identifiers

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Hom-based cognitive monitoring

Identifier Type: -

Identifier Source: org_study_id

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