UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015607
Receipt number R000017821
Scientific Title Diagnosis of Alzheimer disease using 11C-PIB PET
Date of disclosure of the study information 2014/11/10
Last modified on 2016/05/31 11:24:07

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Basic information

Public title

Diagnosis of Alzheimer disease using 11C-PIB PET

Acronym

Diagnosis of Alzheimer disease using 11C-PIB PET

Scientific Title

Diagnosis of Alzheimer disease using 11C-PIB PET

Scientific Title:Acronym

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.


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



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

1st name
Middle name
Last name Hiroshi Honda

Organization

Kyushu University Hospital

Division name

Department of clinical radiology

Zip code


Address

3-1-1 Maidashi

TEL

092-642-5695

Email

honda@radiol.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Baba

Organization

Kyushu University

Division name

Clinical Radiology

Zip code


Address

3-1-1 Maidashi

TEL

092-642-5695

Homepage URL


Email

sbaba127@radiol.med.kyushu-u.ac.jp


Sponsor or person

Institute

kyushu university hospital

Institute

Department

Personal name



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)



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

2014 Year 11 Month 10 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

Preinitiation

Date of protocol fixation

2014 Year 09 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017821


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name