Home-based Cognitive Monitoring in MCI
Usefulness of a Home-based Cognitive Monitoring in Non-demented Patients With High-risk of Dementia: a Prospective Observational Study
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedApril 20, 2020
April 1, 2020
11 months
April 15, 2020
April 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Hippocampal atrophy grade
at baseline
Number of lacunes
at baseline
Number of microbleeds
at baseline
Study Arms (2)
high risk MCI
MCI patients with amyloid beta positive (based on peripheral blood level)
low risk MCI
MCI patients with amyloid beta negative (based on peripheral blood level)
Interventions
a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0\~30; higher score indicates better cognition)
Eligibility Criteria
clinically diagnosed mild cognitive impairment according to Petersen's criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uijeongbu St. Mary's hospital
Uijeongbu-si, 11765, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YunJeong Hong, MD, PhD
Uijeongbu St. Mary's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 17, 2020
Study Start
December 1, 2019
Primary Completion
November 1, 2020
Study Completion
December 30, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share