Unique ID issued by UMIN | UMIN000043650 |
---|---|
Receipt number | R000049845 |
Scientific Title | Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions |
Date of disclosure of the study information | 2021/03/22 |
Last modified on | 2022/11/16 13:31:23 |
Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Japan |
Diagnostic Phase: Not determined
Treatment Phase: Adults (male and female)with suspected mild cognitive impairment (MCI)
Adult |
Others
NO
Diagnostic Phase
EEG data (ERP*1, ERD/S*2 and resting state biomarkers) will be measured and correlated with cognitive function scores measured by the Cogstate Brief Battery (CBB) test.
Treatment Phase
To evaluate the correlation between the iRemember device and the placebo device in adults with suspected mild cognitive impairment (MCI) using the change in CBB test score from baseline (V1) to 15 weeks after the start of training with the research device as an index.
Efficacy
Change in learning/working memory score from baseline (V1) to 15 weeks after the start of training with the research instrument
Change in psychomotor function/Attention score from baseline (V1) to 15 weeks after the start of training with the research instrument
Change in each task (Detection, Identification, One-Card Learning, and One-Back) score from baseline (V1) to 15 weeks after the start of training with the research instrument
Change in QOL from baseline (V1) to 15 weeks after the start of training with the research device, calculated using EQ-5D-5L.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Other |
iRemember device
Placebo device
65 | years-old | <= |
84 | years-old | >= |
Male and Female
(1) Age: Japanese between 65 and 80 years old (at the time of obtaining consent)
(2) Gender: male and female
3) Those who can commute to the medical institution where the study will be conducted
4) Composite score B less than 90 both times in the two Cogstate Brief Battery (CBB) tests conducted in the DiagnosticPhase.
(5) Those who have the ability to operate a computer mouse and keyboard.
(6) Those who can participate in the study for about 15 weeks.
7) Those who have normal to almost normal vision and hearing. (vii) Those with normal to almost normal vision and hearing, and those who can use corrective lenses, hearing aids, etc. if necessary.
(viii) A person who is willing to participate twice a week for the trial of the research equipment.
(1) Those who have participated in a clinical study using the investigational drug within 6 months prior to study enrollment.
2) Those with a history of psychotic disorder, currently active depression, bipolar disorder, adjustment disorder, somatoform disorder, anxiety disorder OCD, or PTSD. (following Axis-1 disorders listed in ICD-10) Those who drink a lot of alcohol on a daily basis
(iii) Alcoholism or drug addiction as defined in ICD-10 within the past 5 years (in remission for more than 1 year and/or less than 3 years) or severe sleep deprivation.
4) History of clinically defined neurological/psychiatric disorders including but not limited to: epilepsy, dementia, clinical stroke (hemiplegia, paraplegia), substance abuse, Parkinson's or other extrapyramidal disorders, major head injury, multiple sclerosis, or personal history of previous neurosurgery or head injury resulting in loss of consciousness, use of drugs intended to improve cognition (cholinesterase inhibitors)
40
1st name | Yoshitaka |
Middle name | |
Last name | Maeda |
Eisai Co., Ltd.
Conversion Science Section
1128088
4-6-10 Koishikawa Bunkyo-ku Tokyo
03-3817-3755
y-maeda@hhc.eisai.co.jp
1st name | Kazuhiro |
Middle name | OHNO |
Last name | Ohno |
Clinical Creative Co., Ltd.
Pharmaceutical Development Division
0620933
1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
09031166218
k-ohno@cli-creative.com
Clinical Creative Co., Ltd.
Eisai Co., Ltd.
Self funding
Japan
Sapporo Yurinokai Hospital Clinical Trial Review Committee
11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
011-771-1501
info@yurinokai.jp
NO
医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital
2021 | Year | 03 | Month | 22 | Day |
Unpublished
Completed
2020 | Year | 11 | Month | 14 | Day |
2020 | Year | 11 | Month | 25 | Day |
2021 | Year | 03 | Month | 22 | Day |
2022 | Year | 11 | Month | 30 | Day |
2021 | Year | 03 | Month | 17 | Day |
2022 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049845
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