Mild DementiaNCT05495113
The Efficacy and Safety of tDCS in Patients With Mild Dementia
A study testing YMS-201B (Device: Mind STIM) in people with Mild Dementia, run by Ybrain Inc. at 2 sites in South Korea.
Trial summary
This study evaluated the effectiveness and safety of improving Mild Dementia by applying tDCS for 26 weeks to patients with Mild Dementia. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Dementia
- What is being tested?
- YMS-201B (Device: Mind STIM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Dec 2019to 30 Dec 2022
- Phase
- Interventional
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 55 to 90 years old.
- Those diagnosed with dementia (major neurocognitive disorder, neurocognitive disorder) according to the criteria of Diagnostic and Statistical Manual (DSM-V) or The International Statistical Classification of Diseases and Related Health Provisions (ICD-10).
- Patients with mild dementia with a MMSE (Mini Mental State Examination) score of 18 points or more and less than 26 points) and less than 26 points.
- Person who has a clinical dementia rating (CDR) global score of 0.5 or 1.0, while CDR-SOB (Sum of Boxes) score satisfies 0.5 to 4.0 points 2)
- Acetylcholinease inhibitors (ACEI) and NMDA receptor inhibitors are those with the same usage and capacity for at least 3 months from the date of screening.
- Patients who are taking drugs for cognitive functional treatment (e.g., pregabalin, gabapentincholinephocerate, etc.) other than acetylcholine inhibitor and NMDA receptor antagonist, and drugs for chronic diseases including hypertension, diabetes, hyperlipidemia, thyroid disease, etc.
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- A person who can read and understand the subject's explanation and consent form, and who can speak at the level of ability to respond to questionnaires.
- A person who can be accompanied by a guardian when visiting a research institute during the clinical trial process, and who can help the guardian to proceed with the clinical trial process normally.
- A person who voluntarily decided to participate in this clinical trial and agreed in writing to the subject's written consent, who can participate in the pre-clinical trial period.
Who cannot join
- A person with a history of uniaxial psychiatric diseases including intellectual disability, schizophrenia, alcoholism, and bipolar disorder in the past.
- A person who has a history of convulsions within 5 years of screening.
- Those who have been diagnosed with severe cerebrovascular stenosis, subdural hemorrhage, brain tumor, and brain abscess through transient ischemic attack, stroke or MRI within one year from the screening date and are considered inappropriate for participation in this test.
- A person who has cerebral damage due to trauma, ischemia, hypoxia, etc.
- A person who has been hospitalized for mental or emotional problems within 5 years of screening.
- A person who abused drugs within 5 years of screening.
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- A person who received treatment for alcoholism within 5 years of screening.
- A person who can't read even with glasses on due to poor eyesight.
- A person who can't understand a conversation because of hearing impairment even when wearing a hearing aid.
- A person who has difficulty breathing when sitting still.
- A person who attempted suicide within 6 months from the screening date.
- A person who is judged to have a problem with brain waves and direct current stimulation electrodes due to deformities, inflammatory reactions, or other dermatological problems in the scalp.
- A person who is judged to have other reasons for prohibition of use of tDCS medical devices (e.g., when a metal plate is inserted into the head, etc.).
- Those who participated in other clinical trials within 30 days of screening.
- Among female subjects who are likely to be pregnant, those who disagree with contraception* in a medically permitted manner during this clinical trial period.
- Medically permitted contraceptive methods: condoms, oral contraceptives that last at least 3 months, injections or insertion contraceptives, etc. are used, and intrauterine contraceptives are installed, etc.
- Pregnant women or lactating women.
- In addition to the above, a person in charge of the test or a person in charge has a clinical significance that is medically judged and deemed inappropriate for this test.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
The Catholic University of Korea at incheon
Incheon, 06591
yongan jung, Professor, +82-032-1544-9004, nucmedkr@gmail.com
- Recruiting
Korea University
Seoul, 02841
kunwoo park, Professor, +82-02-920-5347, kunu@korea.ac.kr
About this study
Official title: In a Patient With Mild Dementia, Improvement of Cognitive Function Using YMS-201B, To Evaluate the Effectiveness and Safety, Randomized, Double-blinded, Sham Control Comparison, Confirmatory
This study evaluated the effectiveness and safety of improving Mild Dementia by applying tDCS for 26 weeks to patients with Mild Dementia.
Read the detailed description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 26weeks through questionnaires.
- Conditions
- Mild Dementia
- Being tested
- YMS-201B (Device: Mind STIM), Sham stimulation using YMS-201B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YMS-201B (Device: Mind STIM)Device
transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Sham stimulation using YMS-201BDevice
Sham stimulation; only 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | Sham Stimulation Receives: Device: Sham stimulation using YMS-201B |
| Real Stimulation (Active) | Experimental | transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 26 weeks Receives: Device: YMS-201B (Device: Mind STIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in K-MMSE (Mini Mental State Examination)
Changes in K-MMSE after 26 weeks form pretreatment (min value : 0 / max value: 30 / Higher scores mean a better outcome)
Measured: After 26 weeks after treatment
Secondary outcomes (7)
Changes in K-IADL(Korean-Isturemental Activities of Daily Living)
Changes in K-IADL after 26 weeks from pretreatment (min value : 0 / max value: 33 / Higher scores mean a worse outcome)
Measured: After 26 weeks after treatment
Changes in CDR(Clinical Dementia rating)
Changes in CDR after 26 weeks from pretreatment (min value : 0 / max value: 3 / Higher scores mean a worse outcome)
Measured: After 26 weeks after treatment
Changes in MoCA-K (Korean version of Montreal Cognitive Assessment)
Changes in MoCA-K after 26 weeks from pretreatment (min value : 0 / max value: 30 / Higher scores mean a better outcome)
Measured: After 26 weeks after treatment
Changes in NPI (Neuropsychiatric Inventory)
Changes in NPI after 26 weeks from pretreatment (min value : 0 / max value: 144 / Higher scores mean a worse outcome)
Measured: After 26 weeks after treatment
Changes in QoL-AD(Quality of life-ADL-AD)
Changes in QoL-AD after 26 weeks from pretreatment (min value : 13 / max value: 52 / Higher scores mean a better outcome)
Measured: After 26 weeks after treatment
Changes in FQoL-AD (Family's Quality of life-ADL-AD)
Changes in FQoL-AD after 26 weeks from pretreatment (min value : 13 / max value: 52 / Higher scores mean a better outcome)
Measured: After 26 weeks after treatment
Changes in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale-Cog 11)
Changes in ADAS-Cog 11 after 26 weeks from pretreatment (min value : 0 / max value: 70 / Higher scores mean a worse outcome)
Measured: After 26 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Dec 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DementiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ybrain Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jung yong an, MD, Principal investigator, Incheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495113
- Sponsor's protocol ID
- YB_ST_SIT1901
- Status last verified
- Sep 2022
- First submitted
- 19 Jan 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to be determine
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In a Patient With Mild Dementia, Improvement of Cognitive Function Using YMS-201B, To Evaluate the Effectiveness and Safety, Randomized, Double-blinded, Sham Control Comparison, Confirmatory
- ClinicalTrials.gov ID
- NCT05495113
- Acronym / sponsor ID
- YB_ST_SIT1901
- Conditions
- Mild Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Ybrain Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 10 Aug 2022 (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 evaluated the effectiveness and safety of improving Mild Dementia by applying tDCS for 26 weeks to patients with Mild Dementia.
Detailed description
Patients received tDCS for 30 minutes with an intensity of 1.5 to 2 mA. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC) 5~7 times a week and they were evaluated every 26weeks through questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Device: Sham stimulation using YMS-201BSham Stimulation |
| Real Stimulation (Active) | Experimental | Device: YMS-201B (Device: Mind STIM)transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 26 weeks |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women aged 55 to 90 years old.
- Those diagnosed with dementia (major neurocognitive disorder, neurocognitive disorder) according to the criteria of Diagnostic and Statistical Manual (DSM-V) or The International Statistical Classification of Diseases and Related Health Provisions (ICD-10).
- Patients with mild dementia with a MMSE (Mini Mental State Examination) score of 18 points or more and less than 26 points) and less than 26 points.
- Person who has a clinical dementia rating (CDR) global score of 0.5 or 1.0, while CDR-SOB (Sum of Boxes) score satisfies 0.5 to 4.0 points 2)
- Acetylcholinease inhibitors (ACEI) and NMDA receptor inhibitors are those with the same usage and capacity for at least 3 months from the date of screening.
Key exclusion criteria (18 listed)
- A person with a history of uniaxial psychiatric diseases including intellectual disability, schizophrenia, alcoholism, and bipolar disorder in the past.
- A person who has a history of convulsions within 5 years of screening.
- Those who have been diagnosed with severe cerebrovascular stenosis, subdural hemorrhage, brain tumor, and brain abscess through transient ischemic attack, stroke or MRI within one year from the screening date and are considered inappropriate for participation in this test.
- A person who has cerebral damage due to trauma, ischemia, hypoxia, etc.
- A person who has been hospitalized for mental or emotional problems within 5 years of screening.
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 |
|---|---|---|
| YMS-201B (Device: Mind STIM)transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | Real Stimulation (Active) |
| Sham stimulation using YMS-201BSham stimulation; only 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC) | Device | Sham Stimulation |
Primary outcome
Changes in K-MMSE (Mini Mental State Examination)
Time frame: After 26 weeks after treatment
Changes in K-MMSE after 26 weeks form pretreatment (min value : 0 / max value: 30 / Higher scores mean a better outcome)
7 secondary outcomes
Changes in K-IADL(Korean-Isturemental Activities of Daily Living)
Time frame: After 26 weeks after treatment
Changes in CDR(Clinical Dementia rating)
Time frame: After 26 weeks after treatment
Changes in MoCA-K (Korean version of Montreal Cognitive Assessment)
Time frame: After 26 weeks after treatment
Changes in NPI (Neuropsychiatric Inventory)
Time frame: After 26 weeks after treatment
Changes in QoL-AD(Quality of life-ADL-AD)
Time frame: After 26 weeks after treatment
Changes in FQoL-AD (Family's Quality of life-ADL-AD)
Time frame: After 26 weeks after treatment
Changes in ADAS-Cog 11 (Alzheimer's Disease Assessment Scale-Cog 11)
Time frame: After 26 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No. to be determine
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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.
jung yong an, MD principal investigator
Incheon St.Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YMS-201B (Device: Mind STIM) in people with Mild Dementia, run by Ybrain Inc. at 2 sites 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 9 inclusion and 18 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Kiwon Lee, PhD (+82-10-3911-3010, kwanghyuk.lee@ybrain.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in K-MMSE (Mini Mental State Examination) (time frame: After 26 weeks after treatment). 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 28 Sep 2022.