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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009863
Receipt No. 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 2017/08/28

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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 Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_2 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_3 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_4 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_5 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_6 PET/MRI/psychological batteries/neurological examinations
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
Middle name
Last name hitoshi Shimada
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 81432063025
Email shimada@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuko Suzuki
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 81432063025
Homepage URL
Email khsuzuki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 No longer recruiting
Date of protocol fixation
2012 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 21 Day
Last follow-up date
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
2017 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011558

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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