UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020065
Receipt number R000023179
Scientific Title Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3
Date of disclosure of the study information 2015/12/07
Last modified on 2017/03/10 09:10:24

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Basic information

Public title

Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3

Acronym

Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3

Scientific Title

Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3

Scientific Title:Acronym

Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3

Region

Japan


Condition

Condition

Alzheimer's disease and mild cognitive impairment

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]AM-PBB3 among dementia (Alzheimer's disease and mild cognitive impairment) 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]AM-PBB3
Effective dose of [18F]AM-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]AM-PBB3
administration dose: 10mCi
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

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. 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

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, symptomatic cerebral infarction, Parkinson's disease and similar conditions)

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 Soichiro Kitamura

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

kitaso@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 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


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

2015 Year 12 Month 07 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

Date of protocol fixation

2015 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 17 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

2015 Year 12 Month 03 Day

Last modified on

2017 Year 03 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name