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

Emocog Inc.1 site in 1 country100 target enrollmentJune 8, 2023

ConditionsMild Cognitive Impairment

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Cognitive Impairment
Sponsor: Emocog Inc.
Enrollment: 100
Locations: 1
Primary Endpoint: Proportion of subjects with the same or reduced ADAS-cog14 score
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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, 24-week parallel study.

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

Registry

clinicaltrials.gov

Start Date

June 8, 2023

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Emocog Inc.

Responsible Party

Sponsor

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 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.

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change in CDR-SB(Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks))
Change in DSC(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 the same or reduced ADAS-cog14 score(Baseline compared to month 3 (12 weeks), 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.(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(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(Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks))
CIBIC-plus score(Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks))
Change in ADCOMS(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(Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks))
Change in ADAS-cog14 total score(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(Baseline compared to month 3 (12 weeks), Baseline compared to month 6 (24weeks), month 3 compared to month 6 (12 weeks))