UMIN-CTR Clinical Trial

Public title

PET study of brain tau deposition in
late onset psychosis using [11C]PBB3

Acronym

PET study of brain tau deposition in
late onset psychosis using [11C]PBB3

Scientific Title

PET study of brain tau deposition in
late onset psychosis using [11C]PBB3

Scientific Title:Acronym

PET study of brain tau deposition in
late onset psychosis using [11C]PBB3

Region

Japan

Condition

Healthy volunteer,late onset psychosis

Classification by specialty

Neurology	Psychosomatic Internal Medicine	Psychiatry
Radiology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate relations between brain
tau deposition and clinical symptoms of
late onset psychosis using PET with
[11C]PBB3.

Basic objectives2

Others

Basic objectives -Others

To investigate relations between brain
tau deposition and clinical symptoms of
late onset psychosis using PET with
[11C]PBB3.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Distribution volume and binding
potential measured by positron emission
tomography with [11C]PBB3

Key secondary outcomes

Difference of spatial distribution of
[11C]PBB3 and [11C]PIB
Correlations between tau deposition and
various clinical scales

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

PET/MRI/neuropsychological
batteries/neurological examinations

Interventions/Control_2

PET/MRI/neuropsychological
batteries/neurological 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

Age-lower limit

40

years-old

<=

Age-upper limit

88

years-old

>=

Gender

Male and Female

Key inclusion criteria

I. Patients
40 y.o.<=Age<=88 y.o. patients of late onset psychosis.
II.Healthy volunteers
40 y.o.<=Age<=88 y.o., normal subjects

Key exclusion criteria

I. Patients
1. Subjects without ability to make
informed consent
2. Subjects with any psychiatric
disorder not due to late onset psychosis
3. Subjects with any organic brain
disorder
4. Subjects with severe physical
complication
5. Subjects with severe claustrophobia
6. Pregnant women
7. Subjects who was considered to be
inappropriate to participate in the study


II. Healthy volunteers
1. Subjects without ability to make
informed consent
2. Subjects with any psychiatric
disorder
3. Subjects with any organic brain
disorder
4. Subjects with severe physical
complication
5. Subjects with severe claustrophobia
6. Subjects who has participated in
other study in recent 6 months.
7. Pregnant women
8. Subjects with tattoo
9. Subjects with metallic medical device
in the body
10. Subjects who was considered to be
inappropriate to participate in the study

Target sample size

57

Name of lead principal investigator

1st name
Middle name
Last name	Keisuke Takahata

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

takahata.keisuke@qst.go.jp

Name of contact person

1st name
Middle name
Last name	Keisuke Takahata

Organization

National Institute of Radiological Sciences

Division name

Molecular Imaging Center

Zip code

Address

Inage-ku, Chiba-shi, Chiba, Japan

TEL

81432063025

Homepage URL

Email

takahata.keisuke@qst.go.jp

Institute

National Institute of Radiological
Sciences

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

11

Month

10

Day

Date of IRB

2014

Year

11

Month

14

Day

Anticipated trial start date

2015

Year

01

Month

10

Day

Last follow-up date

2019

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

08

Day

Last modified on

2019

Year

12

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018596