UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009863 |
|---|---|
| Receipt number | R000011558 |
| Scientific Title | Mapping of brain tau deposition in tauopathy by PET with [11C]PBB3 |
| Date of disclosure of the study information | 2013/02/14 |
| Last modified on | 2022/08/02 12:43:36 |
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Basic information
Public title
Mapping of brain tau deposition in tauopathy by PET with [11C]PBB3
Acronym
PBB3 3rd protocol
Scientific Title
Mapping of brain tau deposition in tauopathy by PET with [11C]PBB3
Scientific Title:Acronym
PBB3 3rd protocol
Region
| Japan |
Condition
Condition
Healthy volunteers 20 years of age or older at the time of obtaining consent
Patients with mild cognitive impairment (MCI) 20 years of age or older at the time of obtaining consent
Patients with Alzheimer's disease (AD) 20 years of age or older at the time of obtaining consent
Patients with corticobasal degeneration (CBD) 20 years of age or older at the time of obtaining consent
Patients with progressive supranuclear palsy (PSP) 20 years of age or older at the time of obtaining consent
Patients with frontotemporal dementia (FTD) 20 years of age or older at the time of obtaining consent
Patients with familial Parkinson's disease with the LRRK2 genetic mutation (PARK8)
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize brain tau deposition in tauopathy in vivo using PET.
Basic objectives2
Others
Basic objectives -Others
To characterize brain tau deposition in tauopathy in vivo using PET.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution volume and binding potential measured by positron emission tomography with [11C]PBB3
- Comparison between patients and age- and gender-matched healthy controls
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/psychological batteries/neurological examinations
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
healthy volunteer
1. 20 years of age or older at the time of obtaining consent. For the judgment of whether or not subject cognitive function can be deemed normal.
2. In order to reduce gender bias, subjects will be selected to match the male-to-female ratios of the patient groups to the maximum extent possible.
3. Healthy subjects who have the ability to consent to participate in this study, to read and understand the informed consent form.
Patients with MCI, AD, CBD, PSP, FTD and PARK8
1. Patients 20 years of age or older at the time of obtaining consent.
2. Patients with MCI and patients with AD: Patients 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, and the acceptable range of drugs that can be used will be partially changed.
Patients with CBD: Patients meeting the diagnostic criteria of the Mayo Clinic (Boeve BF, 2003) and/or the modified version of the Cambridge diagnostic criteria (Mathew R, 2011).
Patients with PSP: Patients meeting the NINDS-SPSP diagnostic criteria (Litvan I, 1996).
Patients with FTD: Patients meeting the diagnostic criteria of Neary et al. (Neary D, 1998), and/or patients diagnosed with FTD and parkinsonism linked to chromosome 17; FTDP-17 (MAPT) based on genetic testing (including presymptomatic carriers).
Patients with PARK8: Patients diagnosed as PARK8 based on genetic testing.
3. Patients who can be accompanied by a legal guardian on the day of study participation at the NIRS.
4. Patients who can understand the outline of this study at the time consent is obtained. Two or more doctors in the collaborating study institutions and the NIRS will judge whether or not the patient can understand the study outline.
Key exclusion criteria
healthy volunteer
1. Subjects with organic brain complications/disorders (including a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions).
2. Patients with substance-related disorders (including drug abuse). For the acceptable range of allowable drugs.
3. 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.
4. Subjects with a pacemaker or other metallic medical device in the body (brain clip, bolts, etc.).
5. Subjects with tattoos. Subjects with claustrophobia.
6. Pregnant, possibly pregnant or lactating women.
7. 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 6 months prior to the start of this study.
8. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study.
Patients with MCI, AD, CBD, PSP, FTD and PARK8
1. Patients with other organic brain complications/disorders (including a history of symptomatic cerebral infarction, Parkinson's disease and similar conditions).
2. Patients with substance-related disorders (including drug abuse). For the acceptable range of allowable drugs.
3. Patients with severe physical complications/disorders or a history of such conditions and who are considered to be inappropriate for participation by doctors with responsibilities in this study.
4. Patients with claustrophobia.
5. Pregnant, possibly pregnant or lactating women.
6. Patients who are considered to be inappropriate for participation by doctors with responsibilities in this study.
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | hitoshi |
| Middle name | |
| Last name | Shimada |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
2638555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
shim@alpha.ocn.ne.jp
Public contact
Name of contact person
| 1st name | kazuko |
| Middle name | |
| Last name | Suzuki |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
2638555
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
a consignment expense for Molecular Imaging
Program on "Research Base for PET
diagnosis" from the Ministry of Education,
Culture, Sports, Science and Technology
(MEXT), Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Radiological Sciences
Address
4-9-1,Anagawa,Inage-ku, Chiba
Tel
+81-(0)43-206-3025
helsinki@qst.go.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
| 2013 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
124
Results
The distribution of tau PET ([11C]PBB3-PET) were consistent with pathological findings. The increased accumulation was associated with the severity of dementia and brain atrophy.
Results date posted
| 2022 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
none
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | 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
| 2013 | Year | 01 | Month | 24 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011558
