UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060286 |
|---|---|
| Receipt number | R000068965 |
| Scientific Title | Retrospective observational study of cross-sectional molecular brain pathology in dementing disease |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 16:38:34 |
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Basic information
Public title
Retrospective observational study of cross-sectional molecular brain pathology in dementing disease
Acronym
Observational studies of the molecular pathogenesis of dementing disease
Scientific Title
Retrospective observational study of cross-sectional molecular brain pathology in dementing disease
Scientific Title:Acronym
Observational studies of the molecular pathogenesis of dementing disease
Region
| Japan |
Condition
Condition
dementing disease patients and healthy controls
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and examine the differences of each PET tracer between healthy subjects and dementing disease patients, and to elucidate the pathology of dementing disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the differences between dementing disease patients and healthy controls for each PET tracer.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
about 800 subjects who underwent PET scans (FDG,PiB,DPA713,PK11195,PBB3,FBP/FMM,PM-PBB3,QAA,2FA,CFT,RAC,FMZ,Met,BCPP-EF,BU99008)
Key exclusion criteria
No
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | yasuomi |
| Middle name | |
| Last name | ouchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Biofunctional Imaging
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2261
ouchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | tatsuhiro |
| Middle name | |
| Last name | terada |
Organization
Hamamatsu University School of Medicine
Division name
HAMAMATSU BioPhotonics Innovation Laboratory
Zip code
431-3192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2261
Homepage URL
tatuhiro@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
rinri@hama-med.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
| 2026 | Year | 01 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068965
