UMIN-CTR Clinical Trial

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

Alzheimer's disease and mild cognitive impairment

Classification by specialty

Neurology

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We aim to elucidate efficacy and safety for tau PET ligand[18F]AM-PBB3 among dementia patients (Alzheimer's disease and mild cognitive impairment) and healthy controls.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Kinetic and quantitative analysis of [18F]AM-PBB3, and effective dose after injection.

Key secondary outcomes

Examination association with extent and distribution of [18F]AM-PBB3, [11C]PBB and [11C]PiB between dementia and healthy controls.

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

Medicine

Interventions/Control_1

PET/MRI/psychological batteries/neurological examinations

Interventions/Control_2

PET/MRI/psychological 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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy controls:
1. Subjects who are considered to be appropriate for participation by doctors with responsibilities in this study.

2. 20 years of age or older at the time of obtaining consent.

Patients:
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, and noticed the disease for clinical treatment. 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 the 1st day of the study.

2. Subjects with organic brain complications/disorders (including traumatic brain injury, a history of 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

Name of lead principal investigator

1st name
Middle name
Last name	Keisuke Takahata

Organization

National Institute of Radiological Sciences

Division name

Department of Functional Brain Imaging Research

Zip code

Address

4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan

TEL

043-206-3251

Email

takahata.keisuke@qst.go.jp

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

043-206-3251

Homepage URL

Email

khsuzuki@nirs.go.jp

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

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

2017

Year

09

Month

12

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

Open public recruiting

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 related information

Registered date

2017

Year

09

Month

11

Day

Last modified on

2017

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023150