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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name