UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057504 |
|---|---|
| Receipt number | R000065703 |
| Scientific Title | Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ) for Social Cognition Assessment in Individuals with Dementia |
| Date of disclosure of the study information | 2025/04/03 |
| Last modified on | 2026/04/10 17:49:08 |
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Basic information
Public title
Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ) for Social Cognition Assessment in Individuals with Dementia
Acronym
Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ)
Scientific Title
Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ) for Social Cognition Assessment in Individuals with Dementia
Scientific Title:Acronym
Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ)
Region
| Japan |
Condition
Condition
Frontotemporal dementia, Alzheimer's disease
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and Validation of the Japanese Version of the Social Norms Questionnaire (SNQ-J): An Examination of Reliability and Validity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The Japanese Version of the Social Norms Questionnaire (SNQ-J)
Key secondary outcomes
Social Functioning: Japanese Version of the Social Function in Dementia (SF-DEM-J)
Social Emotional Cognition Assessment: Dynamic Socioemotional Test Battery (DSTB), 20-Item Totonto Alexithymia Scale (TAS-20)
Neuropsychiatric Symotoms: Subset of the Neuropsychiatric Inventory Questionnaire (NPI) (i.e., Excitement, Depression, Anxiety, Apathy, Disinhibition, and Irritability)
Global Cognitive Function: CDR plus NACC FTLD (FTLD-CDR), MMSE, Subset of the Addenbrooke's Cognitive Examination-III (ACE-III) (i.e., "Language" tasks)
Base
Study type
Observational
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals diagnosed with FTD (bvFTD, SD, PNFA) or AD.
Participants with a family caregiver who has a comprehensive understanding of their daily life, non-family caregivers such as professional care staff, or medical professionals (e.g., nurses) who are well-acquainted with the patient's daily life, especially in the case of hospitalized patients (as evaluation of neuropsychiatric symptoms and social functioning is required).
Individuals (and their caregivers) who have provided informed consent both verbally and in writing.
Key exclusion criteria
Individuals who have lived in Japan for less than 20 years.
Participants who provided invalid responses (i.e., incomplete responses or clearly incorrect answers).
Individuals who exhibit significant language comprehension impairment on language function tests (i.e., those with a score below 22 on the language subscale of the ACE-III).
Patients with dementia due to medication or cerebrovascular disorders, those with physical conditions that may affect cognitive function (e.g., severe medical illnesses), or patients with co-occurring psychiatric disorders such as schizophrenia, mood disorders, or substance abuse.
Other individuals deemed unsuitable by the principal investigator, co-investigators, or attending physician.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yoshiyama |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Psychiatry
Zip code
565-0871
Address
D3, 2-2 Yamadaoka, Suita City, Osaka
TEL
+81-6-6873-3058
yukiyamamoto@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kanemoto |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Psychiatry
Zip code
565-0871
Address
D3, 2-2 Yamadaoka, Suita City, Osaka
TEL
+81-6-6879-3051
Homepage URL
yukiyamamoto@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research (KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board, Osaka University Hospital
Address
4th Floor, Advanced Medical Innovation Center, Osaka University Hospital, 2-2 Yamadaoka, Suita City, Osaka
Tel
+81-6-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the clinical utility of the SNQ-J, we will examine the correlations between the SNQ-J scores, collected from patients with FTD and AD, and the scores from various assessments (SF-DEM-J, DSTB, TAS-20, subsets of the NPI, FTLD-CDR, MMSE, and ACE-III). Additionally, we will assess the diagnostic validity of the SNQ-J using ROC analysis.
Management information
Registered date
| 2025 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065703
