UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers
Acronym	Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers
Scientific Title	Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers
Scientific Title:Acronym	Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers
Region	Japan

Condition
Condition	Healthy people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To collect and develop the standard data of the cognitive function screening tool, the Processing Speed test (PST), on Japanese healthy volunteers in order to utilize it for cognitive function test on patients with multiple sclerosis (MS)
Basic objectives2	Others
Basic objectives -Others	To collect and develop the standard data of the cognitive function screening tool, the Processing Speed test (PST), on Japanese healthy volunteers in order to utilize it for cognitive function test on patients with multiple sclerosis (MS)
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Distribution of PST score
Key secondary outcomes	1.Distribution of PST scores stratified by educational status 2.Distribution of PST scores stratified by age 3.Distribution of PST scores stratified by gender

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Mentally healthy subjects without any neurological, psychiatric, or developmental disorders 2.Subjects aged >= 20 years and <= 65 years 3.Subjects who provide written consent form to participate in this study after full explanation of the study. Minor subjects need additional written consent form signed by legal representative 4.Subjects who can communicate in Japanese 5.Subjects who had not conducted iPad-based PST test previously 6.Male and female
Key exclusion criteria	1.Subjects who have treated for or have history of any of following disease motor tic or vocal tic (including diagnosis of Tourette syndrome), head trauma with severe unconsciousness (more than 30 min), stroke (including ischemic and hemorrhagic stroke or transient ischemic attack (TIA)), neurological, developmental, medical, or conditional arterial disease including that in carotid artery, cerebral palsy, epilepsy, brain tumor, dementia (including mild cognitive disorder and Alzheimer's disease), chronic meningitis, multiple sclerosis, pernicious anemia, normal pressure hydrocephalus, HIV infection, Parkinson's disease, Huntington's disease, learning disability, attention deficit disorder, untreated hypertension (160/100 mmHg), severe cardiac disease, insulin-dependent diabetes mellitus, endocrine disorder, renal disease, glaucoma, or chronic obstructive pulmonary disease 2.Subjects with psychiatric disorder diagnosed by DSM-V criteria 3. Subjects with history of drug abuse and alcohol dependence syndrome 4. Subjects who are treated by currently prescribed psychotropic drugs for psychotic disorder, epilepsy, chronic sedative drug/hypnotic or narcotic analgesic (selective serotonin reuptake inhibitors (SSRI) and serotonin & norepinephrine reuptake inhibitors (SNRI) are permitted) 5. Subjects who are treated by any of following drugs which are expected to affect cognitive function Adderall, Ritalin(methylphenidate), TOPINA(topiramate), EXELON(rivastigmine tartrate), ARICEPT(donepezil hydrochloride), specific analgesic drug such as oxycodone
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Niino
Organization	National Hospital Organization Hokkaido Medical Center
Division name	Department of Clinical Research
Zip code	063-0005
Address	7-1-1, Yamanote 5 jo, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-8111
Email	niino.masaaki.tc@mail.hosp.go.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Hayashi
Organization	PPD-SNBL
Division name	Department of Clinical Development
Zip code	530-6116
Address	Nakanoshima daibiru 16F, 3-3-23 Nakanoshima, Kita-ku, Osaka
TEL	06-4560-6949
Homepage URL
Email	Tatsuya.Hayashi@ppdi.com

Sponsor
Institute	Biogen Japan Ltd.
Institute
Department

Funding Source
Organization	Biogen Japan Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Ethics commitee of Hokkaido Medical Center
Address	7-1-1, Yamanote 5 jo, Nishi-ku, Sapporo, Hokkaido
Tel	011-611-8111
Email	hashiba.miki.er@mail.hosp.go.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	北海道医療センター（北海道）

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 13 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	270
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	2019 Year 06 Month 07 Day
Date of IRB	2019 Year 06 Month 25 Day
Anticipated trial start date	2019 Year 07 Month 13 Day
Last follow-up date	2019 Year 08 Month 29 Day
Date of closure to data entry	2019 Year 09 Month 17 Day
Date trial data considered complete	2019 Year 09 Month 19 Day
Date analysis concluded

Other
Other related information	The items to be examined in healthy subjects are described below. Age, sex, years of education, PST score

Management information
Registered date	2019 Year 07 Month 11 Day
Last modified on	2020 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042571