Mild Cognitive ImpairmentDREAMNCT05938426

Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study

A study testing ET-101 in people with Mild Cognitive Impairment, run by Emocog Inc. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The purpose of this study is to evaluate the efficiency and safety of a digital therapeutics(ET-101) for mild cognitive impairment (MCI). This is a randomized, sham-controlled, assessor-blinded, 24-week parallel study. 100 MCI patients will be randomly assigned to two groups. Read more about this study

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: ET-101
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteSouth Korea
Study dates: 8 Jun 2023to 30 Jun 2024
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

55-85 years old
Patients diagnosed with mild cognitive impairment according to Petersen criteria
A person with subjective memory complaints
Memory degradation of z-score ≤ -1 from the normal range of age, gender, and level of education in the memory area of the CREAD-NP or SNSB battery
The functional performance of overall cognitive function and daily life ability is sufficiently preserved.
Not dementia

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MMSE 27 or less
Adequate vision and hearing for clinical trial
Global CDR 0.5
If approved AD treatment drugs(AChEI, memantine, or both) are being administered, they should be administered at a stable dose for at least 12 weeks prior to randomization.
Have an identified trial partner (defined as someone who can assist the subject during the trial and spends at least 8 hours per week with the subject). The test partner must provide informed consent. This partner must also be willing and able to provide follow-up information to the subject during the trial. In the opinion of the investigator, the trial partner should spend sufficient time with the subject on a regular basis to ensure that the trial requirements are met. The permanent study partner does not have to live in the same residence as the subject. For study partners not residing with the subject, the investigator should ensure that the subject can easily contact the study partner while the study partner is not with the subject. If it is uncertain whether a subject's care arrangement is suitable for selection, the investigator should discuss this with the Medical Monitor. The trial partner should participate directly in visits where the clinical evaluation of CDR, EQ-5D, ADCS MCI-ADL are performed.
No difficulty in using mobile applications using smartphone
A person who owns his/her smartphone
A person who can call his/her guardian using smartphone by himself/herself
No difficulty in reading and writing Korean
Willingness and ability to comply with all aspects of the clinical trial protocol

Who cannot join

History of a transient ischemic attack(TIA), stroke, seizure within 12 months
Psychiatric symptoms that include;
History of diagnosis of psychiatric disorders or symptoms that may interfere with the subject's testing procedure (e.g., psychosis, major depression)
Responding "yes" to item 4 or 5 to suicidal ideation part of C-SSRS or any suicidal behavior within 6 months prior to screening, at screening or at randomization visit, or being hospitalized or treated for suicidal behavior in the past 5 years prior to screening
All other clinically significant abnormalities, such as
Physical examinations, neurological examinations, and vital signs at screening or baseline that, in the opinion of the investigator, may require additional examination or treatment that may interfere with the study procedure or safety

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Other medical conditions (e.g., heart, respiratory, gastrointestinal, kidney disease) that are not adequately stable controlled or that, in the investigator's opinion, may affect the safety of the subject or interfere with the evaluation of the trial
A known or suspected history of drug or alcohol abuse or dependence within 2 years prior to screening
Prohibited concomitant medication
Surgery that requires general anesthesia is scheduled during the trial period.If only local anesthesia is required and the surgery is the day case without hospitalization after surgery or if, in the opinion of the investigator, the operation does not interfere with the test procedure and the safety of the subject, they should not be excluded
History of any type(online/offline) of cognitive intervention or participation in clinical trial regarding cognitive intervention within 12 months

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Gachon University Gil Medical Center
Incheon

Other trials in South Korea

About this study

Official title: Digital Therapeutics (ET-101) Research on Efficiency and Safety About Mild Cognitive Impairment, Randomized, Sham Device, Assessor-blinded, Multi-center Pivotal Study

The purpose of this study is to evaluate the efficiency and safety of a digital therapeutics(ET-101) for mild cognitive impairment (MCI).

This is a randomized, sham-controlled, assessor-blinded, 24-week parallel study.

100 MCI patients will be randomly assigned to two groups. The control group will be provided with a sham device.

Conditions: Mild Cognitive Impairment
Being tested: ET-101, Sham Device
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ET-101Device
Patients have training sessions twice a day. Each training session takes about 10~25 minutes. Cognitive training programs include meditation, cognitive training, and cognitive testing.
Sham DeviceDevice
Sham device has only cognitive function test excluding training programs.

Study groups in NCT05938426
Study group	Role	What they receive
ET-101	Active comparator	Treatment group Receives: Device: ET-101
Sham Device	Sham comparator	Sham group Receives: Device: Sham Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of subjects with the same or reduced ADAS-cog14 score
The 14 items of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog14): Total scores range from 0 to 90, with higher scores indicating more worsening. Compare the proportion of subjects with the same or reduced ADAS-cog14 score between ET-101 and Sham group.
Measured: Baseline compared to month 6 (24 weeks)

Secondary outcomes (11)

Proportion of subjects with the same or reduced ADAS-cog14 score
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), month 3 compared to month 6 (12 weeks)
Change in ADAS-cog14 total score
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Proportion of subjects with decreased ADAS-Cog scores each at 0, 1, 2, 3, 4, 5 or more points.
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Proportion of subjects with increased K-MMSEII score
Korean Mini-Mental State Examination 2nd edition (K-MMSE): A score of 30 represents the least impairment and 0 represents the most severe impairment.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in CDR-SB
Clinical Dementia Rating-Sum of Boxes (CDR-SB): Total scores range from 0 to 18, with higher scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in K-MMSEII
K-MMSE II: Total scores range from 0 to 30, with lower scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
CIBIC-plus score
Clinicians Interview-based Impression of Change (CIBIC-plus): The patient and their care giver are interviewed and questioned by the clinician. It evaluates global function and is scored from 1 (marked improvement) to 7 (marked worsening). The baseline value for CIBIC-plus is represented by Clinician's Interview-based Impression of Severity score (CIBIS).
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in ADCOMS
Alzheimer's Disease Composite Score (ADCOMS): Composite scores range from 0.0 to 1.97, with higher scores indicating more worsening.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in DSC
Digit Symbol Coding (DSC): DSC test is sensitive to changes in information processing speed, provides measures of response speed and accuracy. A test score measures the number of correct responses in 120 seconds. A higher score indicates greater processing speed.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in ADCS-ADL
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Scale (ADCS-ADL): Total scores range from 0 to 78, with lower scores indicating worse function.
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in EQ-5D
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D): EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Total scores range from 3 (worst health state) to 1 (perfect health state).
Measured: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202330 Jun 2024

First posted10 Jul 2023
Study start8 Jun 2023
Primary completion31 Mar 2024 (estimated)
Study completion30 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05938426
Sponsor's protocol ID: EMC-ET-101
Acronym: DREAM
Status last verified: Feb 2024
First submitted: 12 Jun 2023
Last updated: 23 Feb 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kang S, Lim JI, Stenzel L, Kim KY, Kim E, Jeon HJ, Park DH, Lim HK, Shim Y, Jang JW, Kim Y, Lee S, Park KH. Efficacy and Safety of Mobile App-Based Metamemory Cognitive Training for Mild Cognitive Impairment: Multicenter Randomized Clinical Trial. JMIR Mhealth Uhealth. 2026 Jan 19;14:e73464. doi: 10.2196/73464.
PubMed 41554532

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mild Cognitive Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital Therapeutics (ET-101) Research on Efficiency and Safety About Mild Cognitive Impairment, Randomized, Sham Device, Assessor-blinded, Multi-center Pivotal Study
ClinicalTrials.gov ID: NCT05938426
Acronym / sponsor ID: DREAM / EMC-ET-101
Conditions: Mild Cognitive Impairment
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 100 participants (estimated)
Lead sponsor: Emocog Inc.Industry (pharma, biotech, devices)
Study start: 8 Jun 2023 (actual)
Primary completion: 31 Mar 2024 (estimated)
Study completion: 30 Jun 2024 (estimated)
First posted: 10 Jul 2023 (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.

The purpose of this study is to evaluate the efficiency and safety of a digital therapeutics(ET-101) for mild cognitive impairment (MCI).

This is a randomized, sham-controlled, assessor-blinded, 24-week parallel study.

100 MCI patients will be randomly assigned to two groups. The control group will be provided with a sham device.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ET-101	Active comparator	Device: ET-101Treatment group
Sham Device	Sham comparator	Device: Sham DeviceSham group

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

55-85 years old
Patients diagnosed with mild cognitive impairment according to Petersen criteria
MMSE 27 or less
Adequate vision and hearing for clinical trial
Global CDR 0.5

Key exclusion criteria (11 listed)

History of a transient ischemic attack(TIA), stroke, seizure within 12 months
Psychiatric symptoms that include;
All other clinically significant abnormalities, such as
A known or suspected history of drug or alcohol abuse or dependence within 2 years prior to screening
Prohibited concomitant medication

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
ET-101Patients have training sessions twice a day. Each training session takes about 10~25 minutes. Cognitive training programs include meditation, cognitive training, and cognitive testing.	Device	ET-101
Sham DeviceSham device has only cognitive function test excluding training programs.	Device	Sham Device

Primary outcome

Proportion of subjects with the same or reduced ADAS-cog14 score
Time frame: Baseline compared to month 6 (24 weeks)
The 14 items of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog14): Total scores range from 0 to 90, with higher scores indicating more worsening. Compare the proportion of subjects with the same or reduced ADAS-cog14 score between ET-101 and Sham group.

11 secondary outcomes

Proportion of subjects with the same or reduced ADAS-cog14 score
Time frame: Baseline compared to month 3 (12 weeks), month 3 compared to month 6 (12 weeks)
Change in ADAS-cog14 total score
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Proportion of subjects with decreased ADAS-Cog scores each at 0, 1, 2, 3, 4, 5 or more points.
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Proportion of subjects with increased K-MMSEII score
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in CDR-SB
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in K-MMSEII
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
CIBIC-plus score
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in ADCOMS
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in DSC
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in ADCS-ADL
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)
Change in EQ-5D
Time frame: Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Derived from this study: PubMed 41554532Kang S, Lim JI, Stenzel L, Kim KY, Kim E, Jeon HJ, Park DH, Lim HK, Shim Y, Jang JW, Kim Y, Lee S, Park KH. Efficacy and Safety of Mobile App-Based Metamemory Cognitive Training for Mild Cognitive Impairment: Multicenter Randomized Clinical Trial. JMIR Mhealth Uhealth. 2026 Jan 19;14:e73464. doi: 10.2196/73464.
Individual participant dataSharing planned: No

Related trials for Mild Cognitive Impairment

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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.

KeeHyung Park principal investigator

Gachon University Gil Medical Center

JaeWon Jang principal investigator

KangWon National University Hospital

HongJun Jeon principal investigator

Konkuk University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ET-101 in people with Mild Cognitive Impairment, run by Emocog Inc. 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 16 inclusion and 11 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 23 Feb 2024. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects with the same or reduced ADAS-cog14 score (time frame: Baseline compared to month 6 (24 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05938426, which also lists 1 linked publication.

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 23 Feb 2024.