UMIN-CTR Clinical Trial

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

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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

84 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) 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.

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

40


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 or person

Institute

Clinical Creative Co., Ltd.

Institute

Department

Personal name



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

Completed

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 11 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

2022 Year 11 Month 16 Day



Link to view the page

Value
https://center6.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