Home-based Cognitive Monitoring in MCI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04350801
• Other study ID #: Hom-based cognitive monitoring
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: Asan Medical Center
• Contact: YunJeong Hong, MD,PhD
• Phone: 820318203933
• Email: hyj2009[@]hanmail.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Uijeongbu St. Mary's hospital	Uijeongbu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hippocampal atrophy grade	baseline brain MRI markers for hippocampal atrophy using Scheltens' visual rating scale (range 0~4, higher score means more hippocampal atrophy)	at baseline
Secondary	Number of lacunes	number of lacunes using manual counting on brain MRI (no limit)	at baseline
Secondary	Number of microbleeds	number of microbleeds using manual counting on brain MRI (no limit)	at baseline