臨床研究等提出・公開システム

BAC App Japanese Standardized Data Acquisition Study

BAC App Japanese Standardized Data Acquisition Study

120

Baseline Characteristics The subjects for analyses were 120 healthy adults and children, who were stratified by age and sex. Ages 12 to 17MALE10FEMALE10,Ages 18 to 29MALE10FEMALE10,Ages 30 to 39MALE10FEMALE10,Ages 40 to 49MALE10FEMALE10,Ages 50 to 59MALE10FEMALE10,Ages 60 to 69MALE10FEMALE10

Initial approval from the Ethics Committee was granted on 6 March 2024, and informed consent was obtained from the first participant on 8 October 2024. Patient enrolment was subsequently completed on 12 June 2025, ahead of the September 2025 deadline specified in the study protocol.

not applicable

The mean and standard deviation for each subscale of the BAC App were calculated for each sex and age category in the healthy adult and pediatric cohorts.However, in the verbal memory task, a difference in scores was observed between Form 1 and Form 3.

We compiled data to support standardization of scores based on sex and age categories. However, since a difference in scores was observed between Forms 1 and 3 of the verbal memory task, it was suggested that when using the BAC App in clinical research, it may be necessary to avoid using Forms 1 and 3 together or to include the differences between the forms as adjustment factors.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1030240378

Nakagome Kazuyuki

National Center of Neurology and Psychiatry

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan

nakagome@ncnp.go.jp

Kubota Ryotaro

National Center of Neurology and Psychiatry

4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan

+81-42-341-2711

rkubota@ncnp.go.jp

Complete

Oct. 07, 2024

Observational

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

health services research

1)Japanese nationals
2)12 years old (junior high school student or older) to 69 years old or younger
3)Healthy adults or children who are determined to be healthy adults or children by SCID-5-RV
4)No history of hospital visits related to mental illness
5)Those who have given written consent

1)Non-native Japanese speakers
2)Estimated IQ less than 70 on the JART-25 test
3)Those who are unsuitable for web-based screening
4)Those who have taken any medications, including over-the-counter medications, within the last week prior to the date consent was obtained.
5)Those who are deemed inappropriate as research subjects by the principal investigator or research assistants

Both

Healthy adults and children

BAC App

+81-42-341-2711

Mar. 01, 2024

None