UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of Alzheimer disease using 11C-PIB PET
Title of the study (Brief title)	Diagnosis of Alzheimer disease using 11C-PIB PET
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of 11C-PIB PET in the differential diagnosis of Alzheimer's type dementia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	relationship between 11C-PIB PET avidity and change of cognitive function.
Key secondary outcomes	relationship between 11C-PIB PETpattern and change of cognitive function.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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
Interventions/Control_1	injection of PET tracer
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Mild dementia is suspected and is not typical AD 2) include atypical young patients 3) Regardless of sex 4) informed consent is available
Key exclusion criteria	1) typical AD 2) can not keep at rest during scan 3) bad general condition 4) receiving anti-amyloid antibody therapy 5) can not sign in the IC or can not understand the IC 6) Those who is thought to be inappropriate by researcher
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Honda
Organization	Kyushu University Hospital
Division name	Department of clinical radiology
Address	3-1-1 Maidashi
TEL	092-642-5695
Email	honda@radiol.med.kyushu-u.ac.jp

Public contact
Name of contact person	Shingo Baba
Organization	Kyushu University
Division name	Clinical Radiology
Address	3-1-1 Maidashi
TEL	092-642-5695
Homepage URL
Email	sbaba127@radiol.med.kyushu-u.ac.jp

Sponsor
Institute	kyushu university hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2014 Year 11 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 09 Month 24 Day
Anticipated trial start date	2014 Year 10 Month 10 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	2014 Year 11 Month 05 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017821