UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037340 |
|---|---|
| Receipt number | R000042571 |
| Scientific Title | Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers |
| Date of disclosure of the study information | 2019/07/13 |
| Last modified on | 2020/01/09 09:45:28 |
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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
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
Tatsuya.Hayashi@ppdi.com
Sponsor or person
Institute
Biogen Japan Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042571
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
