UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026490 |
|---|---|
| Receipt number | R000030428 |
| Scientific Title | Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3 |
| Date of disclosure of the study information | 2017/03/13 |
| Last modified on | 2020/05/29 11:17:31 |
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Basic information
Public title
Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Acronym
Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Scientific Title
Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Scientific Title:Acronym
Investigation for efficacy and safety of tau PET ligand [18F]PM-PBB3
Region
| Japan |
Condition
Condition
Alzheimer's disease (AD), mid cognitive impairment (MCI), progressive supranuclear pusy (PSP) and corticobasal syndrome (CBS).
Classification by specialty
| Neurology | Psychiatry | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to elucidate the efficacy and safety for [18F]PM-PBB3 among neurodegeneration (AD, MCI, PSP and CBS) sucjects and healthy controls.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetic and quantitative analysis of [18F]PM-PBB3
Effective dose of [18F]PM-PBB3
Key secondary outcomes
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)
PET ligand: [18F]PM-PBB3
administration dose: 5mCi
number of dose: single dose
2)
PET ligand: [11C]PBB3
administration dose: (body weight(kg)/5)mCi
number of dose: single dose
3)
PET ligand: [11C]BTA
administration dose: 15mCi
number of dose: single dose
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(efficacy assessment)
Healthy subjects:
1. Healthy subjects who have the ability to consent to participate in this study
2. 20 years of age or older at the time of obtaining consent
Dementia subjects:
1. 20 years of age or older at the time of obtaining consent.
2. Subjects who can be accompanied by a legal guardian on the day of study participation at the NIRS.
3.
AD, MCI: Subjects meeting the inclusion criteria in the J-ADNI core study except for age. However, the range of CDR (Clinical dementia rating) in patients with AD will be 0.5-2, and the range of MMSE (Mini Mental State Examination) will be 26 points or less
PSP:Subjects meeting the criteria of NINDS-SPSP
CBS: Subjects meeting the criteria of Mayo clinic
and/or Cambridge
(exposure dose assessment)
1. Healthy subjects who have the ability to consent to participate in this study
2. 50 years of age or older at the time of obtaining consent
Key exclusion criteria
1. Subjects who show obviously abnormal blood data at 1st day of the study
2. Subjects with organic brain complications/disorders (including a history of traumatic brain injury with loss of consciousness and/or hospital treatment, symptomatic cerebral infarction or hemorrhage)
3. Patients with substance-related disorders (including drug abuse)
4. Subjects with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by the aforementioned doctors with responsibilities in this study
5. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.)
6. Subjects with tattoos
7. Subjects with claustrophobia
8. Pregnant, possibly pregnant or lactating women
9. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 12 months prior to the start of this study
10. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shimada |
Organization
National Institute of Radiological Sciences
Division name
Department of Functional Brain Imaging Research
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
shimada.hitoshi@qst.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Suzuki |
Organization
National Institute of Radiological Sciences
Division name
Clinical Research Support Section
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
Homepage URL
suzuki.kazuko@qst.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
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
Address
Tel
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
| 2017 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030428
