The Efficacy and Safety of tDCS in Patients With Mild Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Dementia
• Intervention / Treatment: Device: Sham stimulation using YMS-201B; Device: YMS-201B (Device: Mind STIM)

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 Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiwon Lee, PhD; Phone Number: +82-10-3911-3010; Email: kwanghyuk.lee@ybrain.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 06591
    • Recruiting
    • The Catholic University of Korea at incheon
    • Contact: yongan jung, Professor; Phone Number: +82-032-1544-9004; Email: nucmedkr@gmail.com
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Korea University
    • Contact: kunwoo park, Professor; Phone Number: +82-02-920-5347; Email: kunu@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Stimulation	Device: Sham stimulation using YMS-201B; Sham stimulation; only 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
Experimental: Real Stimulation (Active); transcranial Direct Current Stimulation (tDCS) application 5 ~7 days a week for 26 weeks	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	After 26 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	After 26 weeks after treatment

Collaborators and Investigators

• Sponsor: Ybrain Inc.
• Investigators: Principal Investigator: jung yong an, MD, Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 25, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: YB_ST_SIT1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: to be determine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No