UMIN-CTR Clinical Trial

Basic information
Public title	The study on the usefulness of positron emission tomography wtih [11C]PBB3
Acronym	The usefulness of tau imaging
Scientific Title	The study on the usefulness of positron emission tomography wtih [11C]PBB3
Scientific Title:Acronym	The usefulness of tau imaging
Region	Japan

Condition
Condition	Alzheimer's disease Psychotic disorders Mood disorders Traumatic brain injury Epilepsy
Classification by specialty	Neurology Geriatrics Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the tau accumulation, progress of pathology, and types of the tau pathology among various disease which were affected by tau pathology. To clarify the relationship between clinical symptoms of the disease and tau protein.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of accumulation and distribution of tau protein in brain.
Key secondary outcomes	Degree of accumulation and distribution of beta-amyloid in brain neuropsychiatrci examination clinical symptoms morphometric MRI functional MRI blood test

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	8
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_2	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_3	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_4	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_5	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_6	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_7	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_8	PET (tau and beta-amyloid), MRI, Neuropsychological test, blood test
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects who have the ability to provide informed consent and adhere to the protocol. Normal controls: - Without past or current history of cognitive dysfunction - Without past or current history of disease and injury that influences the central nervous system - Mini-Mental State Exam score is 28 or more Alzheimer's disease: - Subject who meet the diagnostic criteria of Alzheimer's disease on International classification of Diseases 10th revision - Informed consents are obtained from patients and one of their family members Psychotic disroders: - Subject who meet the diagnostic criteria of F2 on International classification of Diseases 10th revision Mood disorders: - Subject who meet the diagnostic criteria of F3 on International classification of Diseases 10th revision Brain injury: Subjects with past history of traumatic brain injury Epilepsy: Subjects with past history of seizure and with electroencephalogram abnormality
Key exclusion criteria	- With past or current history of serious medical illness - With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy - Subjects who has possibility of pregnancy or is breast-feeding - Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv - Subjects who received contrast or radioactive agent within two days of the examination. - Subjects who scheduled receiving contrast or radioactive agent the day after the examination. - Subjects who are judged as not suitable for participation in this study
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yoshiro Middle name Last name Okubo
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Email	okubo-y@nms.ac.jp

Public contact
Name of contact person	1st name Amane Middle name Last name Tateno
Organization	Nippon Medical School
Division name	Department of Neuropsychiatry
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL	03-3822-2131
Homepage URL
Email	amtateno@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel	03-3822-2131
Email	clinicaltrial@nms.ac.jp

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	2014 Year 08 Month 18 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	Completed
Date of protocol fixation	2014 Year 08 Month 15 Day
Date of IRB	2014 Year 08 Month 18 Day
Anticipated trial start date	2014 Year 08 Month 21 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 08 Month 07 Day
Last modified on	2020 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017170