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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029084
Receipt No. R000023150
Scientific Title Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3
Date of disclosure of the study information 2017/09/12
Last modified on 2017/09/11

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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
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

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 043-206-3251
Homepage URL
Email khsuzuki@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

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
2017 Year 09 Month 12 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 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
Other related information

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023150

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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