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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043650
Receipt No. 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 2021/10/13

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Basic information
Public title Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Acronym Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Scientific Title Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Scientific Title:Acronym Exploratory Evaluation of the Best Brain iRemember System for Cognitive and Executive Functions
Region
Japan

Condition
Condition Diagnostic Phase: Not determined
Treatment Phase: Adults (male and female)with suspected mild cognitive impairment (MCI)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in learning/working memory score from baseline (V1) to 15 weeks after the start of training with the research instrument
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 iRemember device
Interventions/Control_2 Placebo device
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria (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) Those with a score of less than 90 on the Cogstate Brief Battery (CBB) test.
(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.
Key exclusion criteria (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)



Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Maeda
Organization Eisai Co., Ltd.
Division name Conversion Science Section
Zip code 1128088
Address 4-6-10 Koishikawa Bunkyo-ku Tokyo
TEL 03-3817-3755
Email y-maeda@hhc.eisai.co.jp

Public contact
Name of contact person
1st name Kazuhiro
Middle name OHNO
Last name Ohno
Organization Clinical Creative Co., Ltd.
Division name Pharmaceutical Development Division
Zip code 0620933
Address 1-12-102, Hiragishi 3-13-1-12, Toyohira-ku, Sapporo City, Hokkaido
TEL 09031166218
Homepage URL
Email k-ohno@cli-creative.com

Sponsor
Institute Clinical Creative Co., Ltd.
Institute
Department

Funding Source
Organization Eisai Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Sapporo Yurinokai Hospital Clinical Trial Review Committee
Address 11-186 Yurigahara, Kita-ku, Sapporo-shi, Hokkaido
Tel 011-771-1501
Email info@yurinokai.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 医療法人社団 札幌百合の会病院
Medical Corporation Association Sapporo Yurinokai Hospital

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2020 Year 11 Month 14 Day
Date of IRB
2020 Year 11 Month 25 Day
Anticipated trial start date
2021 Year 03 Month 22 Day
Last follow-up date
2022 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 17 Day
Last modified on
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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