UMIN-CTR Clinical Trial

Basic information
Public title	PET Imaging of Brain Amyloid Using 11C-PIB in Neurological Diseases
Acronym	11C-PIB PET in Neurological Diseases
Scientific Title	PET Imaging of Brain Amyloid Using 11C-PIB in Neurological Diseases
Scientific Title:Acronym	11C-PIB PET in Neurological Diseases
Region	Japan

Condition
Condition	Alzheimer's disease Neurodegenerative diseases
Classification by specialty	Neurology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Recent advances in the development of PET tracers such as 11C-PIB can assess noninvasive brain amyloid deposits, which are the specific biomarker for Alzheimer's disease and can be an important method for early diagnosis or differential diagnosis in Alzheimer's disease or other neurolodegenerative diseases. The purpose of this study is to evaluate 11C-PIB PET imaging for diagnosis of Alzheimer's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	11C-PIB PET imaging
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	11C-PIB PET
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with cognitive dysfunction and suspicion of Alzheimer's disease
Key exclusion criteria	1. Patients who cannot stay rest on a scanner bed at least for 20 minutes
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidenao Fukuyama
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Zip code
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3695
Email	fukuyama@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoya Oishi
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Zip code
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-3695
Homepage URL
Email	noishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Human Brain Research Center, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	J-ADNI
Organization
Division
Category of Funding Organization
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	2010 Year 09 Month 13 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	2010 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date	2011 Year 03 Month 01 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	2010 Year 09 Month 13 Day
Last modified on	2016 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005042

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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