NCT04350801

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

April 15, 2020

Last Update Submit

April 16, 2020

Conditions

Keywords

mild cognitive impairmentblood amyloid betahome-based cognitive monitoring

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)

Diagnostic Test: home-based cognitive monitoring

low risk MCI

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

Diagnostic Test: home-based cognitive monitoring

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)

high risk MCIlow risk MCI

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • YunJeong Hong, MD, PhD

    Uijeongbu St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YunJeong Hong, MD,PhD

CONTACT

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

Locations