UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation for efficacy and safety of tau PET ligand [18F]AM-PBB3
Title of the study (Brief title)	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	Keisuke Takahata
Organization	National Institute of Radiological Sciences
Division name	Department of Functional Brain Imaging Research
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	Kazuko Suzuki
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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