UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041383 |
|---|---|
| Receipt number | R000047241 |
| Scientific Title | Multicenter study of brain imaging-fluid biomarker correlation in neuropsychiatric disorders |
| Date of disclosure of the study information | 2020/08/11 |
| Last modified on | 2020/08/11 08:02:56 |
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Basic information
Public title
Multicenter study of brain imaging-fluid biomarker correlation in neuropsychiatric disorders
Acronym
Brain imaging-fluid biomarker correlation in neuropsychiatric disorders
Scientific Title
Multicenter study of brain imaging-fluid biomarker correlation in neuropsychiatric disorders
Scientific Title:Acronym
Brain imaging-fluid biomarker correlation in neuropsychiatric disorders
Region
| Japan |
Condition
Condition
Alzheimer's disease and other psychiatric and neurological disorders underlying the accumulation of abnormal proteins such as tau protein
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to explore the relevance of brain imaging findings/ fluid biomarkers to clinical information., fluid biomarkers to clinical information, and fluid biomarkers to brain imaging findings
Basic objectives2
Others
Basic objectives -Others
to explore the relevance of brain imaging findings and fluid biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the association among tau/amyloid PET tracer, brain atrophy/function, fluid biomarkers and clinical information
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
[11C]PiB: approx. 370MBq (10mCi)
18F]PM-PBB3: approx. 185MBq (5mCi)
PET scan,
MRI scan
Neuropsychological testing, and
up to 10 ml of blood and CSF examinations
Interventions/Control_2
[11C]PiB: approx. 370MBq (10mCi)
18F]PM-PBB3: approx. 185MBq (5mCi)
PET scan,
MRI scan
Neuropsychological testing, and
up to 10 ml of blood and CSF examinations
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who meet the diagnostic criteria for psychiatric and neurological disorders, such as Alzheimer's disease, where the accumulation of abnormal proteins, such as tau protein, has been suggested to be involved in the disorder.
Key exclusion criteria
(1) Patients with complications or those with a history of such complications and who are judged by the researcher or other physicians to be inappropriate for the study.
(2) Patients with severe claustrophobia.
(3) The person who is pregnant or may be pregnant and the person who is breastfeeding.
(4) In the case of PET examination in this study, in consideration of exposure in nuclear medicine examination, the subject must be within 6 months from the time of participation in other studies involving radiation exposure.
(5) Other persons who are judged by the physician to be unsuitable as research subjects.
Target sample size
460
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Higuchi |
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba
TEL
043-251-2111
higuchi.makoto@qst.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tagai |
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Scienc
Division name
Department of Functional Brain Imaging Research
Zip code
263-8555
Address
4-9-1 Anakawa, Inage-ku, Chiba City, Chiba
TEL
043-251-2111
Homepage URL
tagai.kenji@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science
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
Certified Review Board
Address
4-9-1 Anagawa, Inage-ku, Chiba
Tel
043-206-4709
helsinki@qst.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 08 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047241
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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