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Digital Therapeutics Research on Efficiency About Mild Cognitive Impairment Study

NCT05938426 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-23

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

ET-101

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.

DEVICE

Sham Device

Sham device has only cognitive function test excluding training programs.

Sponsors & Collaborators

  • Emocog Inc.

    lead INDUSTRY

Principal Investigators

  • KeeHyung Park · Gachon University Gil Medical Center

  • JaeWon Jang · KangWon National University Hospital

  • HongJun Jeon · Konkuk University Medical Center

  • EoSu Kim · Severance Hospital

  • HyunKook Lim · Yeouido St. Mary's Hospital

  • YongSoo Shim · Eunpyeong St. Mary's Hospital

  • KeunYou Kim · SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938426 on ClinicalTrials.gov