Home-based Cognitive Monitoring in MCI

April 16, 2020 updated by: YunJeong Hong, MD, Asan Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

clinically diagnosed mild cognitive impairment according to Petersen's criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
high risk MCI
MCI patients with amyloid beta positive (based on peripheral blood level)
Diagnostic test: 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)
low risk MCI
MCI patients with amyloid beta negative (based on peripheral blood level)
Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
home-based cognitive monitoring score
Time Frame: 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
3 months (at baseline, 3 months from baseline, 6 months from baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hippocampal atrophy grade
Time Frame: at baseline
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
Time Frame: at baseline
number of lacunes using manual counting on brain MRI (no limit)
at baseline
Number of microbleeds
Time Frame: at baseline
number of microbleeds using manual counting on brain MRI (no limit)
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: YunJeong Hong, MD, PhD, Uijeongbu St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hom-based cognitive monitoring

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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