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Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers

Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers - Clinical Study to develop standard data of cognitive function screening tool, Processing Speed Test, on Japanese healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000037340
Enrollment
200
Registered
2019-07-13
Start date
2019-07-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy people

Interventions

None listed

Sponsors

Biogen Japan Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Distribution of PST score

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTatsuya Hayashi

PPD-SNBL Department of Clinical Development

Tatsuya.Hayashi@ppdi.com06-4560-6949

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026