Mild Cognitive ImpairmentNCT04350801
Home-based Cognitive Monitoring in MCI
An observational study of Mild Cognitive Impairment, run by Asan Medical Center at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- home-based cognitive monitoring
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2019to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinically diagnosed mild cognitive impairment according to Petersen's criteria
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Uijeongbu St. Mary's hospital
Uijeongbu-si, 11765
YunJeong Hong, MD, PhD, 820318203933, hyj2009@hanmail.net
About this study
Official title: 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
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- home-based cognitive monitoring
- Keywords
- mild cognitive impairment, blood amyloid beta, home-based cognitive monitoring
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based cognitive monitoringDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| high risk MCI | MCI patients with amyloid beta positive (based on peripheral blood level) Receives: Diagnostic Test: home-based cognitive monitoring | |
| low risk MCI | MCI patients with amyloid beta negative (based on peripheral blood level) Receives: Diagnostic Test: home-based cognitive monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
home-based cognitive monitoring score
a 3-5 minutes brief cognitive testing (range 0~30, higher score means better outcome) using telephone
Measured: 3 months (at baseline, 3 months from baseline, 6 months from baseline)
Secondary outcomes (3)
Hippocampal atrophy grade
baseline brain MRI markers for hippocampal atrophy using Scheltens' visual rating scale (range 0~4, higher score means more hippocampal atrophy)
Measured: at baseline
Number of lacunes
number of lacunes using manual counting on brain MRI (no limit)
Measured: at baseline
Number of microbleeds
number of microbleeds using manual counting on brain MRI (no limit)
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Dec 2019
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YunJeong Hong, MD, Asan Medical Center
- Investigators
- YunJeong Hong, MD, PhD, Principal investigator, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350801
- Sponsor's protocol ID
- Hom-based cognitive monitoring
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of a Home-based Cognitive Monitoring in Non-demented Patients With High-risk of Dementia: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04350801
- Acronym / sponsor ID
- Hom-based cognitive monitoring
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment, blood amyloid beta, home-based cognitive monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high risk MCI | – | Diagnostic Test: home-based cognitive monitoringMCI patients with amyloid beta positive (based on peripheral blood level) |
| low risk MCI | – | Diagnostic Test: home-based cognitive monitoringMCI patients with amyloid beta negative (based on peripheral blood level) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinically diagnosed mild cognitive impairment according to Petersen's criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based cognitive monitoringa newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0~30; higher score indicates better cognition) | Diagnostic test | high risk MCI, low risk MCI |
Primary outcome
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 secondary outcomes
Hippocampal atrophy grade
Time frame: at baseline
Number of lacunes
Time frame: at baseline
Number of microbleeds
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YunJeong Hong, MD, PhD principal investigator
Uijeongbu St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YunJeong Hong, MD,PhD (820318203933, hyj2009@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
home-based cognitive monitoring score (time frame: 3 months (at baseline, 3 months from baseline, 6 months from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.