UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053565 |
|---|---|
| Receipt number | R000061122 |
| Scientific Title | Astrocyte imaging study using positron emission tomography with [11C]BU99008 for dementia and psychiatric disease |
| Date of disclosure of the study information | 2024/02/29 |
| Last modified on | 2024/02/07 16:11:56 |
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Basic information
Public title
Astrocyte imaging study using positron emission tomography for dementia and psychiatric disease
Acronym
Astrocyte imaging study using positron emission tomography for dementia and psychiatric disease
Scientific Title
Astrocyte imaging study using positron emission tomography with [11C]BU99008 for dementia and psychiatric disease
Scientific Title:Acronym
Astrocyte imaging study using positron emission tomography with [11C]BU99008 for dementia and psychiatric disease
Region
| Japan |
Condition
Condition
Alzheimer's disease, dementia with lewy body(Parkinson's disease), fronto-temporal dementia, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, high cortical dysfunction, and mild cognitive impairments
Classification by specialty
| Neurology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to identify the reactive astrocyte by using positron emission tomography with [11C]BU99008 in dementing disease (mild cognitive impairments, Alzheimer's disease, dementia with lewy body, Parkinson's disease, fronto-temporal dementia, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, and high cortical dysfunction)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quantitative analysis of the distribution of the [11C]BU99008
Key secondary outcomes
correlation of reactive astrocyte with cognitive decline, activated microglia, and mitochondrial dysfunction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
1, intravenous injection of 370MBq dose of [11C]BU99008
2, intravenous injection of 370MBq dose of[11C]DPA713
3, intravenous injection of 185MBq of [18F]BCPP-EF
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
Demnetiing disease patients who met the clinical criteria of the MCI, AD, DLB, PD, FTD, PSP, CBD, MSA, high cortical dysfunction.
Healthy subjects whose ADL is normal.
All participants who are able to scan PET imaging.
Key exclusion criteria
1, Pregnant, possibly pregnant or lactating women
2, Subjects with claustrophobia
3, patient who had the illness which influence the results of PET study
4, patient who was medicated the drugs which influence the results of PET study
5, Patient with DM whose BS was more than 240mg/dL
6, Subjects who are considered to be inappropriate for participation by the doctors with responsibilities in this study
Target sample size
90
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, Preeminent Medical Photonics, Education & Research Center
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
Department of Biofunctional Imaging, Preeminent Medical Photonics, Education & Research Center
Zip code
1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka
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
| 2024 | Year | 02 | Month | 29 | 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
| 2024 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061122
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| Registered date | File name |
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| Registered date | File name |
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