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Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study (DREAM)

Primary Purpose

Mild Cognitive Impairment

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ET-101
Sham Device
Sponsored by
Emocog Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 MMSE 25 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 Exclusion Criteria: 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 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

Sites / Locations

  • Gachon University Gil Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ET-101

Sham Device

Arm Description

Treatment group

Sham group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in ADAS-cog14 total score
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Proportion of subjects with decreased ADAS-Cog score
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
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.
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.
Change in K-MMSEII
K-MMSE II: Total scores range from 0 to 30, with lower scores indicating more worsening.
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).
Change in ADCOMS
Alzheimer's Disease Composite Score (ADCOMS): Composite scores range from 0.0 to 1.97, with higher scores indicating more worsening.
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.
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.
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).

Full Information

First Posted
June 12, 2023
Last Updated
July 3, 2023
Sponsor
Emocog Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05938426
Brief Title
Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study
Acronym
DREAM
Official Title
Digital Therapeutics (ET-101) Research on Efficiency and Safety About Mild Cognitive Impairment, Randomized, Sham Device, Assessor-blinded, Multi-center Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emocog Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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, 12-week parallel study. 100 MCI patients will be randomly assigned to two groups. The control group will be provided with a sham device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ET-101
Arm Type
Active Comparator
Arm Description
Treatment group
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Sham group
Intervention Type
Device
Intervention Name(s)
ET-101
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Sham device has only cognitive function test excluding training programs.
Primary Outcome Measure Information:
Title
Proportion of subjects with the same or reduced ADAS-cog14 score
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in ADAS-cog14 total score
Description
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Time Frame
12 weeks
Title
Proportion of subjects with decreased ADAS-Cog score
Description
ADAS-cog14: Total scores range from 0 to 90, with higher scores indicating more worsening.
Time Frame
12 weeks
Title
Proportion of subjects with increased K-MMSEII score
Description
Korean Mini-Mental State Examination 2nd edition (K-MMSE): A score of 30 represents the least impairment and 0 represents the most severe impairment.
Time Frame
12 weeks
Title
Change in CDR-SB
Description
Clinical Dementia Rating-Sum of Boxes (CDR-SB): Total scores range from 0 to 18, with higher scores indicating more worsening.
Time Frame
12 weeks
Title
Change in K-MMSEII
Description
K-MMSE II: Total scores range from 0 to 30, with lower scores indicating more worsening.
Time Frame
12 weeks
Title
CIBIC-plus score
Description
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).
Time Frame
12 weeks
Title
Change in ADCOMS
Description
Alzheimer's Disease Composite Score (ADCOMS): Composite scores range from 0.0 to 1.97, with higher scores indicating more worsening.
Time Frame
12 weeks
Title
Change in DSC
Description
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.
Time Frame
12 weeks
Title
Change in ADCS-ADL
Description
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.
Time Frame
12 weeks
Title
Change in EQ-5D
Description
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).
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Adverse events rate
Description
Adverse events rate
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 MMSE 25 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ye-Eun Byeon
Phone
82-2-6745-0001
Email
grace@emocog.com
First Name & Middle Initial & Last Name or Official Title & Degree
JuneSik Mune
Phone
82-2-6745-0001
Email
js@emocog.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KeeHyung Park
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JaeWon Jang
Organizational Affiliation
KangWon National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HongJun Jeon
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EoSu Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HyunKook Lim
Organizational Affiliation
Yeouido St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YongSoo Shim
Organizational Affiliation
Eunpyeong St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KeeHyung Park

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study

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