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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06264557
Other study ID # RW-MCI-01
Secondary ID ROWAN
Status Recruiting
Phase N/A
First received
Last updated
Start date January 17, 2024
Est. completion date May 1, 2025

Study information

Verified date February 2024
Source Rowan
Contact Hyunsung Yoon
Phone 010-5544-0970
Email yswon111@rowan.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cognitive therapy software for improving cognitive function for patients with mild cognitive impairment


Description:

A multicenter, prospective, comparative, randomized, independent rater-blind, superiority, pivotal clinical trial to compare the safety and efficacy of the Cognitive therapy software 'SUPERBRAIN DEX' for improving cognitive function with a control group for patients with mild cognitive impairment


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
SB-100
Cognitive training will be conducted once a day, and it will take 15 to 30 minutes. It consists of cognitive training and educational videos.
Other:
Educational book
Book of education on daily rules for preventing dementia

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Sponsors (1)

Lead Sponsor Collaborator
Rowan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary K-RBANS The closer the total score of 160 points, the worse the cognitive state is, and the closer it is to 40, the worse the cognitive state is Baseline, 16 weeks after treatment
Secondary K-RBANS The closer the total score of 160 points, the worse the cognitive state is, and the closer it is to 40, the worse the cognitive state is Baseline, 8 weeks after treatment
Secondary K-MMSE-2 Total scores range from 0 to 30, with lower scores indicating more worsening. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary CDR-SB The closer to CDR 0 grade, the more normal the cognitive state, and the closer to CDR 3 grade, the worse the cognitive state. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary K-IADL It consists of a total of 11 items (0-3 points), and the score is calculated by dividing the total score by the number of corresponding items, and the closer it is to 3, the worse the cognitive state is. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary PRMQ The closer to the lowest 16 points, the normal memory ability, and the closer to the total score of 80 points, the worse the memory ability. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary GDS-15 The closer it is to 0, the less depressed it is, and the closer it is to the total score of 15, the more depressed it is. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary QOL-AD The closer the total score of 52 points, the higher the quality of life, and the closer the minimum score of 13 points, the lower the quality of life. Baseline, 8 weeks after treatment, and 16 weeks after treatment
Secondary ADAS-Cog14 Total scores range from 0 to 90, with higher scores indicating more worsening. Baseline, 16 weeks after treatment
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